Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
Study NCT ID:
NCT04410068
Status:
UNKNOWN
Last Update Posted:
2021-10-06
First Post:
2020-05-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Electric Heating Pad Versus Forced-air Warming to Prevent Inadvertent Perioperative Hypothermia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2023-09-26', 'unreleaseDate': '2023-09-27'}, {'releaseDate': '2023-09-29', 'unreleaseDate': '2023-09-29'}, {'resetDate': '2024-04-12', 'releaseDate': '2023-10-20'}], 'estimatedResultsFirstSubmitDate': '2023-09-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2020-05-29', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core body temperature', 'timeFrame': 'through study completion, an average of 12 months', 'description': 'temperatured recorded in esophagus'}], 'secondaryOutcomes': [{'measure': 'Rescues number', 'timeFrame': 'through study completion, an average of 12 months', 'description': 'Compare number of rescues required by each system to avoid mild hypothermia'}, {'measure': 'skin lesions', 'timeFrame': 'through study completion, an average of 12 months', 'description': 'Detect possible skin complications related to heating'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Temperature Change, Body', 'Hypothermia; Anesthesia']}, 'referencesModule': {'references': [{'pmid': '30447894', 'type': 'BACKGROUND', 'citation': 'Calvo Vecino JM, Casans Frances R, Ripolles Melchor J, Marin Zaldivar C, Gomez Rios MA, Perez Ferrer A, Zaballos Bustingorri JM, Abad Gurumeta A; Grupo de trabajo de la GPC de Hipotermia Perioperatoria No Intencionada de la SEDAR. Clinical practice guideline. Unintentional perioperative hypothermia. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Dec;65(10):564-588. doi: 10.1016/j.redar.2018.07.006. Epub 2018 Nov 15. English, Spanish.'}, {'pmid': '12697600', 'type': 'BACKGROUND', 'citation': 'Matsuzaki Y, Matsukawa T, Ohki K, Yamamoto Y, Nakamura M, Oshibuchi T. Warming by resistive heating maintains perioperative normothermia as well as forced air heating. Br J Anaesth. 2003 May;90(5):689-91. doi: 10.1093/bja/aeg106.'}, {'pmid': '17042850', 'type': 'BACKGROUND', 'citation': 'Ng V, Lai A, Ho V. Comparison of forced-air warming and electric heating pad for maintenance of body temperature during total knee replacement. Anaesthesia. 2006 Nov;61(11):1100-4. doi: 10.1111/j.1365-2044.2006.04816.x.'}, {'pmid': '26787794', 'type': 'BACKGROUND', 'citation': 'John M, Crook D, Dasari K, Eljelani F, El-Haboby A, Harper CM. Comparison of resistive heating and forced-air warming to prevent inadvertent perioperative hypothermia. Br J Anaesth. 2016 Feb;116(2):249-54. doi: 10.1093/bja/aev412.'}]}, 'descriptionModule': {'briefSummary': 'Compare core body temperature after laparoscopic surgery using the forced air heating system versus the WARMTAC® (a carbon fiber electric blanket).', 'detailedDescription': 'In order to prevent perioperative hypothermia, we will compare two different heating sistems, one of them is an electric pad made with carbon fiber and the other system is a forced-air blanket. Both of them will be situated under the patient during all the laparoscopic surgey.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age at the time of the preoperative visit.\n* Patients who will undergo elective laparoscopic surgery\n* Patients who sign the informed consent indicating that they have been informed of all relevant aspects of the trial.\n\nExclusion Criteria:\n\n* Axillary temperature\\> 37.5ºC\n* Active infection\n* Dysfunction of the autonomic system'}, 'identificationModule': {'nctId': 'NCT04410068', 'briefTitle': 'Comparison of Electric Heating Pad Versus Forced-air Warming to Prevent Inadvertent Perioperative Hypothermia', 'organization': {'class': 'OTHER', 'fullName': 'Parc de Salut Mar'}, 'officialTitle': 'Comparison of Electric Heating Pad Versus Forced-air Warming to Prevent Inadvertent Perioperative Hypothermia: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2019-8860-I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electrical heating pad', 'description': 'Electrical heating pad (WARMTAC device). Patients will be randomized to one arm.\n\nIn this arm, the WARMTAC device will be conected and warmed to 41 degrees before patients lay down.', 'interventionNames': ['Device: WARMTAC']}, {'type': 'EXPERIMENTAL', 'label': 'forced-air warming device', 'description': 'Forced-air warming device (3M device). In this arm, the 3M blanket will be conected to forced-air machine and warmed to 41 degrees before patients lay down.', 'interventionNames': ['Device: 3M Bair Hugger']}], 'interventions': [{'name': 'WARMTAC', 'type': 'DEVICE', 'description': 'Randomization to one of the arms previous to surgery.', 'armGroupLabels': ['Electrical heating pad']}, {'name': '3M Bair Hugger', 'type': 'DEVICE', 'description': 'Randomization to one of the arms previous to surgery.', 'armGroupLabels': ['forced-air warming device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08029', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'LLUIS GALLART GALLEGO', 'role': 'CONTACT', 'email': 'lluis@gallart.cat', 'phone': '680986184'}], 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Mirea Chanza', 'role': 'CONTACT', 'email': 'mchanza@parcdesalutmar.cat', 'phone': '0034667550215'}], 'overallOfficials': [{'name': 'Mireia Chanza, Physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PSMar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc de Salut Mar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-09-26', 'type': 'RELEASE'}, {'date': '2023-09-27', 'type': 'UNRELEASE'}, {'date': '2023-09-29', 'type': 'RELEASE'}, {'date': '2023-09-29', 'type': 'UNRELEASE'}, {'date': '2023-10-20', 'type': 'RELEASE'}, {'date': '2024-04-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Parc de Salut Mar'}}}}