Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-27 @ 10:53 PM
Study NCT ID:
NCT07013734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Positioning and Its Influence on BIS, NOL, and Cerebral Oxygenation in Anesthetized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-06-02', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation in Bispectral Index (BIS)', 'timeFrame': 'Perioperative period'}], 'secondaryOutcomes': [{'measure': 'Variation of Nociception Level (NOL) Index', 'timeFrame': 'Perioperative period'}, {'measure': "Variation of the patient's cerebral saturation measured with cerebral oximetry", 'timeFrame': 'Perioperative period'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Monitoring of Depth of Anesthesia']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to find out how changes in body position during surgery might affect brain monitoring results in patients who are under general anesthesia.The main question it aims to answer is:\n\n\\- Does patient positioning have an impact on Bispectral Index (BIS) and Nociception Level (NOL) index monitoring (which are values of awareness in anesthesized patients).\n\nParticipants will undergo their surgery as planned, except for these extra features:\n\n* Extra monitors placed to check brain activity, pain response, and brain oxygen levels.\n* Before the surgery, while the patient is asleep, the patient's table will be moved into two different positions for 2 minutes each to see if the values on the monitor change.\n\nParticipants will then have to answer a short questionnaire after surgery about their memories before and after the anesthesia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from Maisonneuve-Rosemont Hospital undergoing elective surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fully consented, adult patients above 18 years old;\n* Supine positioning during the surgery;\n* Surgery requiring patient positioning with Vacuform mats.\n\nExclusion Criteria:\n\n* Patient with Body Mass Index (BMI) ≥ 35;\n* Patients over 80 years old.'}, 'identificationModule': {'nctId': 'NCT07013734', 'briefTitle': 'Patient Positioning and Its Influence on BIS, NOL, and Cerebral Oxygenation in Anesthetized Patients', 'organization': {'class': 'OTHER', 'fullName': "Ciusss de L'Est de l'Île de Montréal"}, 'officialTitle': 'Patient Positioning and Its Influence on BIS, NOL, and Cerebral Oxygenation in Anesthetized Patients', 'orgStudyIdInfo': {'id': '2025-3803'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Ciusss de L'Est de l'Île de Montréal", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}