Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-01-01 @ 8:49 AM
Study NCT ID:
NCT06805435
Status:
COMPLETED
Last Update Posted:
2025-02-07
First Post:
2025-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Continuous Non-Invasive Monitoring Accurate When Used on the Lower Extremity: Finger Vs Toe?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2025-01-28', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between output from the continuous non-invasive blood pressure cuff placed on the volunteers index finger compared to the output from the continuous non-invasive blood pressure cuff placed on the volunteers 2nd toe.', 'timeFrame': 'Continuous non-invasive blood pressure measurements will be collected for 10 minutes', 'description': 'The continuous non-invasive blood pressure cuff measures mean arterial pressure which will be compared between the index finger and 2nd toe of the same volunteer.'}], 'secondaryOutcomes': [{'measure': 'Effects of length and circumference of the middle phalanx of the 2nd toe on the accuracy of the continuous non-invasive blood pressure cuff measurements compared to the measurements taken from the index finger.', 'timeFrame': 'Continuous non-invasive blood pressure measurements will be collected for 10 minutes.', 'description': 'To compare the measurements from the index finger cuff to the 2nd toe cuff based on the length and circumference of the middle phalanx of the 2nd toe.'}, {'measure': 'Validity of the continuous non-invasive blood pressure monitoring cuff on the toe compared to automatic blood pressure cuff measurements on the contralateral lower extremity.', 'timeFrame': 'Continuous non-invasive blood pressure measurements will be collected for 10 minutes', 'description': 'To compare and assess the validity of the continuous non-invasive blood pressure monitoring cuff on the 2nd toe compared to measurements taken via an automatic blood pressure cuff from the contralateral lower extremity.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Acumen IQ cuff', 'continuous non-invasive blood pressure monitoring', 'Toe'], 'conditions': ['Validation', 'Blood Pressure', 'Device']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to assess the validity of a continuous non-invasive blood pressure monitoring device, Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA), when used on the toe in healthy volunteers. The main questions it aims to answer is:\n\n• Can a continuous non-invasive blood pressure monitoring device accurately measure hemodynamic parameters when placed on a toe as compared to the finger in a healthy volunteer?\n\nSecondary Outcomes:\n\n* What are the effects of length and circumference of the middle phalanx of the 2nd toe on the accuracy of the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) measurements compared to the measurements taken from the finger?\n* What are the effects of a Valsalva maneuver on the measurements taken from the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) on a toe compared to the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) placed on the finger.\n\nParticipants will:\n\n* Have blood pressures taken using an automatic blood pressure cuff (both arms and both calves)\n* Have a continuous non-invasive blood pressure monitoring sensor placed on their finger and toe simultaneously for 10 minutes\n* Be asked to valsalva briefly to induce a change in blood pressure to be observed by the dual sensors', 'detailedDescription': 'For each volunteer the investigators will measure the length from the proximal interphalangeal (PIP) joint to the distal interphalangeal (DIP) joint of the 2nd toe as well as the circumference at the center of the middle phalanx of the 2nd toe which the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) will be placed on. Data including the hemodynamic measurements from the toe and finger cuffs will be collected. Laterality of cuff placement on finger and toes will be noted. Age, gender, height, and weight of the volunteers will be recorded.\n\nDuring the trials the monitors will not be visible once necessary adjustments have been made and before data collection has begun. The two data sets from each sensor (finger and toe) will be linked together at the time of data collection. The investigators will not be able to tell which volunteer the data belongs to when analyzing the data.\n\nPrior to the placing the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA), baseline blood pressures will be taken at the start of the study from each extremity using an automatic blood pressure cuff.\n\nThe healthy volunteer will have one Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) placed on the 2nd toe and one Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) place on the index finger. The study will be performed in a break room with minimal external stimulus. The volunteer will be asked to lie supine for approximately 3 minutes until the sensors have calibrated. They will remain in the supine position for another 5 minutes for data collection. An automatic blood pressure cuff on the contralateral lower extremity to the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) will measure blood pressures at 0, 2.5, and 5 minutes. They will then be asked to perform a Valsalva maneuver at their own discretion for no longer than 5 seconds. The research protocol will be performed by the research coordinator on staff. Data collection occurs automatically every 20 seconds, but manual recording of data will be performed. The two continuous monitoring devices will be synced at the beginning of the study by simultaneously inputting a flagged event from which the start time will be inferred during data analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consistent of a convenience sample of available healthy volunteer medical students or residents.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years or older\n* Medical student or resident\n\nExclusion Criteria:\n\n* Medical history of Raynaud's or peripheral vascular disease\n* Allergy to adhesive"}, 'identificationModule': {'nctId': 'NCT06805435', 'briefTitle': 'Is Continuous Non-Invasive Monitoring Accurate When Used on the Lower Extremity: Finger Vs Toe?', 'organization': {'class': 'OTHER', 'fullName': 'Riverside University Health System Medical Center'}, 'officialTitle': 'Is Continuous Non-Invasive Monitoring Accurate When Used on the Lower Extremity?: a Pilot Study', 'orgStudyIdInfo': {'id': '2219626-3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy volunteers', 'description': 'Healthy volunteers consisting of medical students and residents at our institution.', 'interventionNames': ['Device: Continuous non-invasive blood pressure monitoring']}], 'interventions': [{'name': 'Continuous non-invasive blood pressure monitoring', 'type': 'DEVICE', 'description': 'A continuous non-invasive blood pressure monitoring cuff will be placed on the volunteers index finger (as intended) and 2nd toe (primary outcome).', 'armGroupLabels': ['Healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92555', 'city': 'Moreno Valley', 'state': 'California', 'country': 'United States', 'facility': 'Riverside University Health System Medical Center', 'geoPoint': {'lat': 33.93752, 'lon': -117.23059}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan is in place to share IPD at this time.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riverside University Health System Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Coordinator', 'investigatorFullName': 'Christopher Baker', 'investigatorAffiliation': 'Riverside University Health System Medical Center'}}}}