Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-03-04 @ 11:44 AM
Study NCT ID:
NCT02177903
Status:
COMPLETED
Last Update Posted:
2024-10-02
First Post:
2014-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2014-06-25', 'studyFirstSubmitQcDate': '2014-06-27', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of hypothermia', 'timeFrame': 'Up to 12 hours, until PACU discharge', 'description': 'The primary endpoint is duration of hypothermia as measured by the area under the curve (AUC). This is achieved by recording patient temperature readings continuously from baseline (prior to initiation of 30 minutes if active or passive pre-warming) until PACU discharge.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hypothermia', 'surgical site infection', 'opioid usage', 'blood loss', 'pain severity', 'anxiety', 'Length of Stay'], 'conditions': ['Hypothermia']}, 'referencesModule': {'references': [{'pmid': '29872966', 'type': 'DERIVED', 'citation': 'Lau A, Lowlaavar N, Cooke EM, West N, German A, Morse DJ, Gorges M, Merchant RN. Effect of preoperative warming on intraoperative hypothermia: a randomized-controlled trial. Can J Anaesth. 2018 Sep;65(9):1029-1040. doi: 10.1007/s12630-018-1161-8. Epub 2018 Jun 5.'}]}, 'descriptionModule': {'briefSummary': 'The application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers. The warmers are commonly used with both the supplied blankets and also with hospital blankets.\n\nSubjects receiving standard care will not benefit from this study. Subjects in the investigational group may benefit in several ways:\n\n* Increased comfort in the pre-operative period by being warmer\n* Decreased incidence of mild hypothermia\n* Possible decreased incidence of transfusion with less bleeding\n* Possible decreased pain and discomfort in the Post-Anesthesia Care Unit (PACU)\n* Possible shorter stay in the PACU and overall Length of Stay (LOS)\n* Possible decreased risk for surgical site infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective or "urgent" surgery under general anesthesia\n* ≥19 years but ≤85 years of age\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Refusal of Informed consent\n* Metabolic derangement/drug therapy already affecting thermal homeostasis\n* Preexisting hypothermia (\\<35.5 degreeC) or hyperthermia (\\>37.5 degreeC) (oral)\n* Surgical procedure anticipated to be longer than 6 hours or less than 1 hour\n* Emergency (category 1a) Surgery\n* Patients undergoing exclusively spinal or epidural anesthesia\n* Patients receiving aortic cross-clamping\n* Patients receiving transdermal medications'}, 'identificationModule': {'nctId': 'NCT02177903', 'briefTitle': 'Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solventum US LLC'}, 'officialTitle': 'Randomized, Prospective Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Perioperative Surgical Outcomes', 'orgStudyIdInfo': {'id': 'EM-05-013093'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Bair PawsPatient Adjustable Warming System', 'description': 'Bair PawsPatient Adjustable Warming System for active pre-warming', 'interventionNames': ['Device: Bair Paws Patient Adjustable Warming System']}, {'type': 'OTHER', 'label': 'Passive pre-warming', 'description': 'Passive pre-warming', 'interventionNames': ['Device: Bair Paws Patient Adjustable Warming System']}], 'interventions': [{'name': 'Bair Paws Patient Adjustable Warming System', 'type': 'DEVICE', 'otherNames': ['Bair Paws Flex Gown'], 'description': 'Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.', 'armGroupLabels': ['Bair PawsPatient Adjustable Warming System', 'Passive pre-warming']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V3L 3W7', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Royal Columbian Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Richard Merchant, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Staff Anesthesiologist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solventum US LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}