Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-03-12 @ 2:13 AM
Study NCT ID:
NCT03193905
Status:
COMPLETED
Last Update Posted:
2017-06-21
First Post:
2017-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}, {'id': 'D007738', 'term': 'Kyphosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-19', 'studyFirstSubmitDate': '2017-01-11', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core temperature > 36 degrees Celsius', 'timeFrame': 'Althrough completion of the study 5 months from now', 'description': 'Core temperature at the start of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypothermia Following Anesthesia', 'Neurosurgery', 'Scoliosis', 'Kyphosis', 'Forced Air Warming', 'Major Spinal Fusion']}, 'descriptionModule': {'briefSummary': 'Background\n\nMajor spinal surgery tend to be lengthy with an increased risk of hypothermia. A quality improvement project of patients undergoing major spinal surgery showed that 67 % were hypothermic at the beginning of surgery. Several patients expressed a feeling of coldness at the arrival of the operating theatre.\n\nAim\n\nTo evaluate if Bairhuggers Full Access Underbody blanket can prevent hypothermia at initiation if used as prewarming and intraoperative warming compared to the results from the local quality improvement project. In addition we aim to explore patients´ experiences of comfort in relation to their temperature.\n\nMethod\n\nTemperature of patients undergoing major spinal surgery (n=30) will be assessed at arrival to the theatre, after insertion of bladder catheter, at the start and end of surgery using a bladder temperature. The patients´ experiences of comfort will be evaluated with a 5 point Likert at the arrival to the operating theatre and after ten minutes of active prewarming with Bairhuggers Full Access Underbody blanket. Preoperatively ten randomly chosen patients will be observed and later interviewed in order to obtain further information regarding their experiences of comfort in relation to their temperature.\n\nConclusion and perspectives\n\nBy increasing the investigators knowledge on Bairhuggers Full Access Underbody blanket and its effects in preventing hypothermia as well as gaining insight to patients´ experiences of comfort in relation to temperature, the investigators anticipate to improve pre-anesthetic care and minimize risk factors associated with hypothermia for patients undergoing major spinal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients for elective major spinal surgery\n* Patients ≥ 14 years\n* Danish language\n\nExclusion Criteria:\n\n* Patients\\> 110 kg\n* Patients with a temperature \\> 37.5 ° C\n* Patients with a temperature ≤ 35 ° C\n* Cognitive impairment to such an extent that the patient does not understand the purpose of, nor is able to cooperate, with the project'}, 'identificationModule': {'nctId': 'NCT03193905', 'briefTitle': 'Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery', 'orgStudyIdInfo': {'id': 'BFAU blanket 2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cotton blanket', 'description': '30 hypothermia patients undergo the standard procedure with a cotton blanket during major spinal surgery', 'interventionNames': ['Procedure: Cotton blanket - control group']}, {'type': 'OTHER', 'label': 'Bairhugger Full Access Underbody blanket', 'description': '30 hypothermia patients undergo the Bairhugger Full Access Underbody blanket procedure during major spinal surgery (new procedure)', 'interventionNames': ['Procedure: Bairhugger Full Access Underbody Blanket']}], 'interventions': [{'name': 'Bairhugger Full Access Underbody Blanket', 'type': 'PROCEDURE', 'description': '30 patients undergo new procedure with a Bairhugger Full Access Underbody Blanket', 'armGroupLabels': ['Bairhugger Full Access Underbody blanket']}, {'name': 'Cotton blanket - control group', 'type': 'PROCEDURE', 'description': '30 patients undergo standard procedure with a cotton blanket', 'armGroupLabels': ['Cotton blanket']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mia Nørgaard Granum', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anaesthetic nurse', 'investigatorFullName': 'Mia Nørgaard Granum', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}