Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-30 @ 5:21 AM
Study NCT ID:
NCT05906368
Status:
COMPLETED
Last Update Posted:
2025-11-04
First Post:
2023-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'limkg2@upmc.edu', 'phone': '412-641-1778', 'title': 'Dr. Katherine Grace Lim', 'organization': 'UPMC, University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '36+ weeks gestation to 12-weeks postpartum per subject', 'eventGroups': [{'id': 'EG000', 'title': 'Conventional Care', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ClearSight Monitoring', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.\n\nClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time-to-treatment of Hypotension (Minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Care', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}, {'id': 'OG001', 'title': 'ClearSight Monitoring', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.\n\nClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.8', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '23.1', 'spread': '17.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From epidural placement until 4-hours post-infusion start', 'description': 'The difference in time between diagnosis of hypotension and treatment by clinical staff between CM and HPI groups', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with a hypotensive event were analyzed for this outcome measure (n=20)'}, {'type': 'PRIMARY', 'title': 'Ease of Use by Clinical Staff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Care', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}, {'id': 'OG001', 'title': 'ClearSight Monitoring', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.\n\nClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}], 'classes': [{'categories': [{'title': 'Disagree', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Neither agree nor disagree', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Agree', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Completely Agree', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'report at 4-hour post-infusion', 'description': 'Clinical nurse reports of ease of use of ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant\'s responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device seems easy to use."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ease of Hypotension Detection by Clinical Staff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Care', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}, {'id': 'OG001', 'title': 'ClearSight Monitoring', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.\n\nClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}], 'classes': [{'categories': [{'title': 'Disagree', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Completely Agree', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Neither agree nor disagree', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Agree', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'report at 4-hour post-infusion', 'description': 'Clinical nurse reports of ease of hypotension detection using ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant\'s responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device seems suitable."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Satisfaction of ClearSight Use by Clinical Staff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Care', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}, {'id': 'OG001', 'title': 'ClearSight Monitoring', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.\n\nClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}], 'classes': [{'categories': [{'title': 'Disagree', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Completely Agree', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Agree', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Neither agree nor disagree', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'report at 4-hour post-infusion', 'description': 'Clinical nurse reports of satisfaction of use of ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant\'s responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device meets my approval."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Time in Hypotension With Mean Arterial Pressure (MAP) <65 mmHg (in Minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Care', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}, {'id': 'OG001', 'title': 'ClearSight Monitoring', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.\n\nClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Epidural placement to 4-hours post-infusion start', 'description': 'Average number of minutes patients spent within hypotensive events for each group (CM and CM + HPI).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nausea (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Care', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}, {'id': 'OG001', 'title': 'ClearSight Monitoring', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.\n\nClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}], 'classes': [{'categories': [{'title': 'Yes Nausea', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'No Nausea', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Epidural placement to 4-hours post-infusion start', 'description': 'Proportion of patients by group reporting nausea within 4-hours of post-epidural placement', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vomiting (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Care', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}, {'id': 'OG001', 'title': 'ClearSight Monitoring', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.\n\nClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}], 'classes': [{'categories': [{'title': 'Yes Vomiting', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No Vomiting', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Epidural placement to 4-hours post-infusion start', 'description': 'Proportion of patients by group reporting Vomiting within 4-hours of post-epidural placement', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Phenylephrine, mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Care', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}, {'id': 'OG001', 'title': 'ClearSight Monitoring', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.\n\nClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '223.3', 'spread': '242.1', 'groupId': 'OG000'}, {'value': '506.7', 'spread': '410.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Epidural placement to 4-hours post-infusion start', 'description': 'Average phenylephrine dose(s) given to patients in CM and CM+HPI groups', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with a hypotensive event and received phenylephrine were analyzed for this outcome measure (n=9)'}, {'type': 'SECONDARY', 'title': 'Total Ephedrine, mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Care', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}, {'id': 'OG001', 'title': 'ClearSight Monitoring', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.\n\nClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '23.3', 'spread': '23.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Epidural placement to 4-hours post-infusion start', 'description': 'Average ephedrine dose(s) given to patients in CM and CM+HPI groups', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with a hypotensive event and received epinephrine were analyzed for this outcome measure (n=19)'}, {'type': 'SECONDARY', 'title': 'Total Intravenous Fluids, mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Care', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}, {'id': 'OG001', 'title': 'ClearSight Monitoring', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.\n\nClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}], 'classes': [{'categories': [{'measurements': [{'value': '550.0', 'spread': '169.6', 'groupId': 'OG000'}, {'value': '535.7', 'spread': '94.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Epidural placement to 4-hours post-infusion start', 'description': 'Average volume of fluids given to patients in CM and CM+HPI groups', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with a hypotensive event and received IV fluids were analyzed for this outcome measure (n=16)'}, {'type': 'SECONDARY', 'title': 'Total Number of Reported Changes in Fetal Heart Rate Category (From Healthy to Deceleration or Excelleration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Care', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}, {'id': 'OG001', 'title': 'ClearSight Monitoring', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.\n\nClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}], 'classes': [{'categories': [{'title': 'Yes - Changes in fetal heart rate', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'No - Changes in fetal heart rate', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Epidural placement to 4-hours post-infusion start', 'description': 'Total number of participants who experienced changes in fetal heart rate category (any)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fetal Heart Rate Decelerations Within 1 Hour of Initiation of ELA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Care', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}, {'id': 'OG001', 'title': 'ClearSight Monitoring', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.\n\nClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Epidural placement to 1-hour post-infusion start', 'description': 'Percentage of patients who experience any fetal heart rate deceleration event \\[Presence (Yes) or absence (No)\\] within 1-hour of epidural placement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Conventional Care', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}, {'id': 'FG001', 'title': 'ClearSight Monitoring', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.\n\nClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Ineligibility criteria identified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Conventional Care', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}, {'id': 'BG001', 'title': 'ClearSight Monitoring', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.\n\nClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response\n\nStandard of Care Blood Pressure Monitoring: Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '29.8', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '29.6', 'spread': '5.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '34.9', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '33.7', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-07', 'size': 231055, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-06T11:11', 'hasProtocol': True}, {'date': '2024-05-07', 'size': 481379, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-25T09:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will wear both a conventional blood pressure cuff and the ClearSight finger cuff throughout the duration of the 4-hours post-epidural placement.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomized to receive standard clinical care (SCC) blood pressure measurement or blood pressure monitoring of HPI via ClearSight with SCC.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2023-05-08', 'resultsFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2023-06-06', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-10', 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-to-treatment of Hypotension (Minutes)', 'timeFrame': 'From epidural placement until 4-hours post-infusion start', 'description': 'The difference in time between diagnosis of hypotension and treatment by clinical staff between CM and HPI groups'}, {'measure': 'Ease of Use by Clinical Staff', 'timeFrame': 'report at 4-hour post-infusion', 'description': 'Clinical nurse reports of ease of use of ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant\'s responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device seems easy to use."'}, {'measure': 'Ease of Hypotension Detection by Clinical Staff', 'timeFrame': 'report at 4-hour post-infusion', 'description': 'Clinical nurse reports of ease of hypotension detection using ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant\'s responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device seems suitable."'}, {'measure': 'Satisfaction of ClearSight Use by Clinical Staff', 'timeFrame': 'report at 4-hour post-infusion', 'description': 'Clinical nurse reports of satisfaction of use of ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant\'s responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device meets my approval."'}], 'secondaryOutcomes': [{'measure': 'Total Time in Hypotension With Mean Arterial Pressure (MAP) <65 mmHg (in Minutes)', 'timeFrame': 'Epidural placement to 4-hours post-infusion start', 'description': 'Average number of minutes patients spent within hypotensive events for each group (CM and CM + HPI).'}, {'measure': 'Nausea (Yes/No)', 'timeFrame': 'Epidural placement to 4-hours post-infusion start', 'description': 'Proportion of patients by group reporting nausea within 4-hours of post-epidural placement'}, {'measure': 'Vomiting (Yes/No)', 'timeFrame': 'Epidural placement to 4-hours post-infusion start', 'description': 'Proportion of patients by group reporting Vomiting within 4-hours of post-epidural placement'}, {'measure': 'Total Phenylephrine, mg', 'timeFrame': 'Epidural placement to 4-hours post-infusion start', 'description': 'Average phenylephrine dose(s) given to patients in CM and CM+HPI groups'}, {'measure': 'Total Ephedrine, mg', 'timeFrame': 'Epidural placement to 4-hours post-infusion start', 'description': 'Average ephedrine dose(s) given to patients in CM and CM+HPI groups'}, {'measure': 'Total Intravenous Fluids, mL', 'timeFrame': 'Epidural placement to 4-hours post-infusion start', 'description': 'Average volume of fluids given to patients in CM and CM+HPI groups'}, {'measure': 'Total Number of Reported Changes in Fetal Heart Rate Category (From Healthy to Deceleration or Excelleration)', 'timeFrame': 'Epidural placement to 4-hours post-infusion start', 'description': 'Total number of participants who experienced changes in fetal heart rate category (any)'}, {'measure': 'Fetal Heart Rate Decelerations Within 1 Hour of Initiation of ELA', 'timeFrame': 'Epidural placement to 1-hour post-infusion start', 'description': 'Percentage of patients who experience any fetal heart rate deceleration event \\[Presence (Yes) or absence (No)\\] within 1-hour of epidural placement.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Anesthesia, Epidural', 'Hypotension']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot trial is to examine the feasibility and ease of use of monitoring by ClearSight in laboring and delivering patients with the intent to compare time-to-treatment of hypotension between conventionally monitored patients (Group CM) and those receiving HPI (Group CM + HPI) monitoring by ClearSight, in a population of healthy laboring women who receive epidural analgesia.', 'detailedDescription': 'In a prospective study, we will achieve the following aims:\n\nTo determine the feasibility and ease of use of the ClearSight monitoring system in the labor-delivery room (LDR) in detecting and monitoring hypotensive events post-epidural labor analgesia placement.\n\nTo compare the Time-to-Treatment of hypotensive events between the conventionally monitored patients (Group CM) and those receiving HPI (Group CM + HPI) monitoring by ClearSight.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant\n* Age ≥ 18 years of age\n* Planning vaginal delivery\n* Receiving epidural labor analgesia (ELA)\n\nExclusion Criteria:\n\n* Non-reassuring fetal tracing at the time of ELA request\n* Contraindications to ELA\n* Significant cardiac arrhythmias or aortic regurgitation\n* Arrhythmia\n* Treatment with antihypertensive medications\n* Pre-eclampsia with or without severe features\n* Preoperative infection\n* Inability to use ClearSight device for any reason\n* Non-English fluency\n* Sustains unintentional dural puncture\n* Incomplete data'}, 'identificationModule': {'nctId': 'NCT05906368', 'briefTitle': 'Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension -- Pilot Study', 'orgStudyIdInfo': {'id': 'STUDY23030009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Conventional Care', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.', 'interventionNames': ['Diagnostic Test: Standard of Care Blood Pressure Monitoring']}, {'type': 'EXPERIMENTAL', 'label': 'ClearSight Monitoring', 'description': 'Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.', 'interventionNames': ['Diagnostic Test: ClearSight HPI Monitoring system', 'Diagnostic Test: Standard of Care Blood Pressure Monitoring']}], 'interventions': [{'name': 'ClearSight HPI Monitoring system', 'type': 'DIAGNOSTIC_TEST', 'description': 'Continuous blood pressure monitoring for precision hypotensive event response', 'armGroupLabels': ['ClearSight Monitoring']}, {'name': 'Standard of Care Blood Pressure Monitoring', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.', 'armGroupLabels': ['ClearSight Monitoring', 'Conventional Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee Womens Hospital of UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Grace Lim, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grace Lim, MD, MS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Associate Professor, Chief Obstetric & Women's Anesthesiology", 'investigatorFullName': 'Grace Lim, MD, MS', 'investigatorAffiliation': 'University of Pittsburgh'}}}}