Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-01 @ 3:50 AM
Study NCT ID:
NCT05625256
Status:
WITHDRAWN
Last Update Posted:
2023-08-07
First Post:
2022-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2022-11-06', 'studyFirstSubmitQcDate': '2022-11-21', 'lastUpdatePostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy', 'timeFrame': 'During hospital admission', 'description': 'The difference between SentiCor-300 and the actual intra-arterial blood pressure for systolic and diastolic pressures.'}], 'secondaryOutcomes': [{'measure': 'Change', 'timeFrame': 'During hospital admission', 'description': 'Comparison of continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements during hemodynamic changes at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in various postures and positions.'}, {'measure': 'Calibration Duration', 'timeFrame': 'During hospital admission', 'description': 'To determine how long an oscillometric calibration of the SentiCor-300 lasts.'}, {'measure': 'Gender and Fitzpatrick index', 'timeFrame': 'During hospital admission', 'description': 'To compare perform class analysis on accuracy versus gender and Fitzpatrick index.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Blood Pressure']}, 'descriptionModule': {'briefSummary': 'To compare continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in supine position.', 'detailedDescription': 'Analysis of number and magnitude of BP changes Adjust endpoint calculation definitions and methods based on this lead in results Estimate sample size for main study Demonstration of capability to quantify and annotate interference in the arterial line signal and detect and changes in patient orientation Parallel recording of SentiCor-300 PPG sensor\n\nMain study:\n\nValidate SentiCor-300 noninvasive blood pressure against direct arterial pressure measurements.\n\nUp to 200 (10 run-in, the balance- study) Run in phase will be performed with Senticor-100, data will be used for sample size estimation of balance study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consenting adults scheduled for elective major surgery that requires an arterial catheter will be recruited into the study. There will be no restriction on race or ethnicity.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical indication for arterial catheter insertion;\n* Age ≥18 years;\n* American Society of Anesthesiologists (ASA) physical status class ≤3;\n* Enrollment will be adjusted as necessary so the final population includes at least 40% men and 40% women;\n* Planned length of surgery \\>60 minutes;\n* Anticipated supine positioning;\n* Anticipated initial recovery in the post-anesthesia care unit.\n\nExclusion criteria:\n\n* Severe peripheral vascular disease;\n* Surgery that involves manipulation of large arteries\n* Bypass surgery\n* Positive Allen's test\n* Inability to insert a catheter into an upper extremity artery;\n* Patients with an arterial-venous shunt for hemodialysis;\n* Inability to measure NIBP on the arm with the arterial catheter;\n* Atria l fibrillation;\n* Body Mass Index (BMI) \\>35kg/m2;\n* Esophageal or nasopharyngeal pathology, coarctation of the aorta;\n* Emergency surgery.\n* Surgery which involves manipulation of major arteries"}, 'identificationModule': {'nctId': 'NCT05625256', 'briefTitle': 'Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Clinical Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure Against Invasive Arterial Blood Pressure', 'orgStudyIdInfo': {'id': '22-511'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Accuracy of Continuous Noninvasive Blood Pressure at Various Stages of Anesthesia', 'description': 'To compare noninvasive continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in various positions.', 'interventionNames': ['Device: SentiCor-300']}], 'interventions': [{'name': 'SentiCor-300', 'type': 'DEVICE', 'description': 'Continuous blood pressure measurement with the SentiCor-300.', 'armGroupLabels': ['Accuracy of Continuous Noninvasive Blood Pressure at Various Stages of Anesthesia']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alparslan Turan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}