Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-31 @ 7:09 PM
Study NCT ID:
NCT05847634
Status:
RECRUITING
Last Update Posted:
2024-12-06
First Post:
2023-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Depth of Sedation and Its Impact on Cerebrovascular Reactivity in Acute Respiratory Distress Syndrome: a Pilot Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2023-04-27', 'studyFirstSubmitQcDate': '2023-04-27', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment', 'timeFrame': '20 months', 'description': 'Recruitment of two patients per month, allowing for seasonal variation in ARDS.'}, {'measure': 'Data Quality', 'timeFrame': '7 days', 'description': 'Physiologic signal with greater than 80% data quality to allow for calculation of SEDopt'}], 'secondaryOutcomes': [{'measure': 'SEDopt', 'timeFrame': '7 days', 'description': 'Optimal depth of sedation that minimizes correlation between tissue oxygenation (StO2) and total hemoglobin (THb) as measure by O3 NIRS and processed EEG monitoring as defined by SedLine PSi.'}, {'measure': 'MAPopt', 'timeFrame': '7 days', 'description': 'Optimal depth of sedation that minimizes correlation between tissue oxygenation (StO2) and mean arterial pressure as measured by invasive arterial line.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Near-Infrared Spectroscopy', 'Depth of Sedation', 'Intensive Care Unit', 'Electroencephalography', 'Acute Respiratory Distress Syndrome'], 'conditions': ['ARDS, Human']}, 'descriptionModule': {'briefSummary': 'Investigation of the feasibility of monitoring processed transcutaneous electroencephalography (EEG), a method of interpreting brain activity, and near-infrared spectroscopy (NIRS), a method of determining levels of tissue oxygenation (StO2) in the brain, for patients with acute respiratory distress syndrome (ARDS) in the ICU.', 'detailedDescription': 'The aim of this study is to determine the feasibility of using Masimo SedLine processed EEG monitoring and Masimo O3 NIRS to monitor optimal depth of sedation for patients with ARDS in the ICU.\n\nTo achieve this, non-invasive devices will be applied to the participant to measure processed EEG signal and StO2. Cerebrovascular reactivity will be determined using the following two values:\n\n1. SEDopt: The optimal depth of sedation that minimizes correlation between StO2 and processed EEG monitoring.\n2. MAPopt: The optimal blood pressure that minimizes correlation between StO2 and MAP.\n\nDemographic information (age, sex, height, weight), past medical history, etiology of ARDS, Disease severity, routine bloodwork, and dose of sedation will also be documented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults admitted to the ICU with ARDS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient admitted to the ICU\n* ARDS confirmed according to the Berlin Definition\n* Invasive mechanical ventilation\n* Deep sedation and/or neuromuscular blockade required for ARDS treatment at the discretion of the treating medical team\n* Application of monitoring devices feasible\n\nExclusion Criteria:\n\n* More than 24 hours elapsed since ICU admission\n* Death is deemed imminent and inevitable during the next 24 hours\n* Known allergy to a textile component of the device\n* Consent declined from patient or authorized third party\n* The treating clinician believes that participation in the study would not be in the best interest of the patient'}, 'identificationModule': {'nctId': 'NCT05847634', 'briefTitle': 'Depth of Sedation and Its Impact on Cerebrovascular Reactivity in Acute Respiratory Distress Syndrome: a Pilot Analysis', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Depth of Sedation and Its Impact on Cerebrovascular Reactivity in Acute Respiratory Distress Syndrome: a Pilot Analysis', 'orgStudyIdInfo': {'id': 'HS25505'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute Respiratory Distress Syndrome', 'description': 'Adults admitted to ICU with ARDS confirmed according to Berlin Definition', 'interventionNames': ['Device: Masimo O3 NIRS cerebral oximetry and SedLine processed EEG']}], 'interventions': [{'name': 'Masimo O3 NIRS cerebral oximetry and SedLine processed EEG', 'type': 'DEVICE', 'description': 'Non-invasive neuromonitoring device for observational study', 'armGroupLabels': ['Acute Respiratory Distress Syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3T2N2', 'city': 'Winnipeg', 'state': 'Manitoba', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Asher Mendelson, MD PhD', 'role': 'CONTACT', 'email': 'asher.mendelson@umanitoba.ca', 'phone': '2047878059'}], 'facility': 'Health Sciences Centre Winnipeg', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'centralContacts': [{'name': 'Asher Mendelson, MD PhD', 'role': 'CONTACT', 'email': 'asher.mendelson@umanitoba.ca', 'phone': '204-787-8059'}], 'overallOfficials': [{'name': 'Asher Mendelson, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Asher Mendelson', 'investigatorAffiliation': 'University of Manitoba'}}}}