Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-01 @ 12:47 AM
Study NCT ID:
NCT04935632
Status:
COMPLETED
Last Update Posted:
2023-02-28
First Post:
2021-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Collection of Temperatures and Hypothermia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-24', 'studyFirstSubmitDate': '2021-06-11', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of intraoperative hypothermia', 'timeFrame': 'Up to 24 hours', 'description': 'From the time of entry into the operating room to the time of exit from the operating room. Hypothermia is defined as a core body temperature below 36°Celsius (presence or absence).'}], 'secondaryOutcomes': [{'measure': 'Incidence of hypothermia in the post-anesthesia care unit (PACU)', 'timeFrame': 'Up to 24 hours', 'description': 'From the time of entry into the PACU, hypothermia is defined as a core body temperature below 36°Celsius (presence or absence).'}, {'measure': 'Tympanic temperature in the post-anaesthesia care unit (PACU)', 'timeFrame': 'Up to 24 hours', 'description': 'From the time of entry into the PACU to the time of exit from the PACU.'}, {'measure': 'Intraoperative tympanic temperature', 'timeFrame': 'Up to 24 hours', 'description': 'From the time of entry into the operating room to the time of exit from the operating room.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypothermia', 'Hypothermia; Anesthesia', 'Hypothermia, Accidental']}, 'referencesModule': {'references': [{'pmid': '33616248', 'type': 'BACKGROUND', 'citation': 'Sari S, Aksoy SM, But A. The incidence of inadvertent perioperative hypothermia in patients undergoing general anesthesia and an examination of risk factors. Int J Clin Pract. 2021 Jun;75(6):e14103. doi: 10.1111/ijcp.14103. Epub 2021 Feb 28.'}]}, 'descriptionModule': {'briefSummary': "Accidental perioperative hypothermia is a frequent complication of anesthesia that favors the occurrence of infections, bleeding and perioperative cardiovascular accidents, and is responsible for perioperative excess mortality. Although preventive measures are widely used, it remains very frequent in France. This observation led a group of experts to draft, under the aegis of the Société Française d'Anesthésie et de Réanimation (SFAR), several recommendations aimed at improving the prevention of perioperative accidental hypothermia.\n\nPerioperative hypothermia is defined as a core body temperature below 36.0 ° Celsius.\n\nThis study aims to evaluate the impact of hypothermia prevention training on the proportion of hypothermic patients in the operating room."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients operated on at the Léon Bérard Centre, whether for scheduled, emergency or outpatient surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>= 18 years old\n* surgeries performed at the Centre Léon Bérard\n\nExclusion Criteria:\n\n* Digestive endoscopy, interventional radiology, brachytherapy (operating rooms outside the central operating room)\n* Patient who decline to participate in the study\n* Active systemic infection\n* Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Intrathoracic Chemotherapy (HITeC)\n* Deprivation of liberty\n* operation performed under local anesthesia only'}, 'identificationModule': {'nctId': 'NCT04935632', 'acronym': 'ROTHY', 'briefTitle': 'Perioperative Collection of Temperatures and Hypothermia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Leon Berard'}, 'officialTitle': "Perioperative Collection of Temperatures and Hypothermia (Recueil périOpératoire Des Températures et de l'Hypothermie - ROTHY)", 'orgStudyIdInfo': {'id': 'ROTHY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Before implementation', 'description': 'Prior to the implementation of the measures resulting from the SFAR recommendations on the prevention of accidental perioperative hypothermia'}, {'label': 'After implementation', 'description': 'After implementation of the measures resulting from the SFAR recommendations on the prevention of accidental perioperative hypothermia', 'interventionNames': ['Behavioral: prevention training']}, {'label': 'at a distance from the implementation', 'description': 'Approximately 8 months after implementation of the measures resulting from the SFAR recommendations on the prevention of accidental perioperative hypothermia.', 'interventionNames': ['Behavioral: prevention training']}], 'interventions': [{'name': 'prevention training', 'type': 'BEHAVIORAL', 'description': 'Evaluate the impact of hypothermia prevention training on the proportion of patients hypothermic patients in the operating room', 'armGroupLabels': ['After implementation', 'at a distance from the implementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69008', 'city': 'Lyon', 'state': 'Rhone', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Leon Berard', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}