Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT04017702
Status:
COMPLETED
Last Update Posted:
2022-04-01
First Post:
2019-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Postoperative Respiratory Depression in High Risk Patients Utilizing Minute Ventilation Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-31', 'studyFirstSubmitDate': '2019-07-09', 'studyFirstSubmitQcDate': '2019-07-11', 'lastUpdatePostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of postoperative respiratory depression', 'timeFrame': '1 year', 'description': 'To define the incidence of postoperative respiratory depression between 2 devices.'}], 'secondaryOutcomes': [{'measure': 'Detection of postoperative respiratory depression in high risk patients.', 'timeFrame': '1 year', 'description': 'To determine the agreement between these 2 devices in detection of postoperative respiratory depression in high risk patients.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Respiratory Depression']}, 'descriptionModule': {'briefSummary': 'Respiratory volume monitor (RVM) (ExSpiron) is superior to continuous pulse oximetry in detection of postoperative respiratory depression in high risk patients.', 'detailedDescription': 'Aims are to: 1) Estimate the incidence of postoperative respiratory depression in high risk patients as detected by continuous pulse oximetry 2) Estimate the incidence of postoperative respiratory depression in high risk patients as detected by continuous respiratory volume monitor (RVM) (ExSpiron) 3) Assess the agreement between the continuous pulse oximetry and continuous respiratory volume monitor (RVM) (ExSpiron) in detection of postoperative respiratory depression in high risk patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Group A; which will involve pregnant women with gestational age between 32-40 weeks. It will take place at:\n\ni. Labor and delivery floor/obstetric floor: 100 patients scheduled for cesarean section under neuraxial anesthesia with 150 mcg intrathecal or 3-mg epidural morphine.\n\nii. Antenatal care: (obstetric floor, Long Wharf women clinic, Women center at Yale)\n\nGroup B; in post anesthesia care units (PACU) and surgical floor: 100 patients scheduled to receive General Anesthesia (GA) and planned to receive opioid intravenously (boluses/patient controlled analgesia (PCA).\n\nGroup C: in step down/ICU; 50 patients suffered from rib fracture and 50 patients after weaning from mechanical ventilation and extubation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who suffered rib fractures or patients who are weaned from mechanical ventilation and recently extubated.\n\nExclusion Criteria:\n\n* Have known contraindication/allergy to neuroaxial/paravertebral nerve block anesthesia\n* Patients allergic to morphine.\n* Have an ASA class \\> IV'}, 'identificationModule': {'nctId': 'NCT04017702', 'briefTitle': 'Detection of Postoperative Respiratory Depression in High Risk Patients Utilizing Minute Ventilation Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Detection of Postoperative Respiratory Depression in High Risk Patients Utilizing Minute Ventilation Monitoring', 'orgStudyIdInfo': {'id': '2000021197'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women with gestational age between 32-40 weeks.', 'description': '100 patients scheduled for cesarean section under neuraxial anesthesia with 150 mcg intrathecal or 3-mg epidural morphine.'}, {'label': 'Patients post anesthesia care units (PACU) and surgical floor.', 'description': '100 patients scheduled to receive General Anesthesia (GA) and planned to receive opioid intravenously (boluses/patient controlled analgesia (PCA).'}, {'label': 'Patients in step down/ICU.', 'description': '50 patients suffered from rib fracture and 50 patients after weaning from mechanical ventilation and extubation.The Expiron will provide continuous information about the respiratory status (tidal volume, respiratory rate and minute ventilation) of non-intubated patients specifically: sleeping or awake; with the use of incentive spirometry; the response to medications and other interventions (such as paravertebral/epidural block); the need for endotracheal re-intubation.', 'interventionNames': ['Device: Expiron respirator']}], 'interventions': [{'name': 'Expiron respirator', 'type': 'DEVICE', 'description': 'Respiratory volume monitor (RVM) (ExSpiron, is a non-invasive FDA approved device that monitors minute ventilation (MV) and provides an early indication of respiratory status in non-intubated patients. The system consists of a lightweight monitor, a patient cable, and a disposable electrode PadSet, which detects changes in breathing.', 'armGroupLabels': ['Patients in step down/ICU.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519-1362', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Aymen Alian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}