Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT01858727
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
2013-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Preoperative Warming on Postoperative 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-05', 'studyFirstSubmitDate': '2013-05-13', 'studyFirstSubmitQcDate': '2013-05-20', 'lastUpdatePostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To assess patient satisfaction', 'timeFrame': '12 hours', 'description': 'patient satisfaction scale (using a Likert scale type (range, 1 to 7) verbally administered questionnaire for patient satisfaction)'}], 'primaryOutcomes': [{'measure': 'Perioperative measurements of core temperature (centigrade ° C)', 'timeFrame': '2-3 hours', 'description': 'After the operation patients will be admitted to the PACU. Here, body temperature will be assessed and the incidence of hypothermic patients (body temperature \\< 36°C)will be measured.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of hemodynamic variables (arterial blood pressure)', 'timeFrame': '2-3 hours', 'description': 'systolic blood pressure (SBP) in mmHg, diastolic blood pressure (DBP) in mmHg, mean arterial pressure (MAP) in mmHg will be measured.'}, {'measure': 'Evaluation of hemodynamic variables (heart rate)', 'timeFrame': '2-3 hours', 'description': 'heart rate (HR) in beats per minute will be measured.'}, {'measure': 'Number of patients with postoperative shivering', 'timeFrame': '2-3 hours', 'description': 'After the operation patients will be admitted to the PACU. Here, postoperative shivering will be measured and graded by visual inspection.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['forced-air', 'hypothermia', 'TUR-P surgery', 'core temperatures', 'prewarming', 'general anaesthesia'], 'conditions': ['Preventing Hypothermia', 'Perioperative Hypothermia']}, 'descriptionModule': {'briefSummary': '36 patients American society of anesthesiology (ASA) physical status I,II and III undergoing general anesthesia for elective transurethral resection of the prostate (TUR-P) surgery will be included in the study. Patients will be randomized into two groups; first group(control group) and second group (forced-air warming). Resistive heating will start when patients are transferred to the operating room table; forced-air warming will start before preoperative 30 minute.', 'detailedDescription': 'The primary aim of this study was to compare the effect of prewarming on perioperative hypothermia in elderly patients undergoing TURP under general anesthesia. In addition, we aimed to evaluate the effects of prewarming on hemodynamic variables, PACU output time, tremor, patient comfort and satisfaction. The investigators plan to enroll 36 patients in 2 groups. Body temperature will be measured at the core temperature, hemodynamic variables. Shivering will be graded by visual inspection. Thermal discomfort scale, patient satisfaction will be evaluated. The investigators hypothesize will decrease the forced air prewarming incidence of perioperative hypothermia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 50-85 years undergoing general anesthesia for TURP surgery\n* ASA physical status I and III patients\n* Body mass index between 15 and 36 kg/m2\n* General anesthesia time is 30-90 minutes\n\nExclusion Criteria:\n\n* without written consent,\n* inadequate Turkish comprehension,\n* known impaired thermoregulation or thyroid disorders,\n* severe hypertension (systolic blood pressure \\[SBP\\]\\>180 mmHg or diastolic blood pressure \\[DBP\\] \\> 110 mmHg in the operating suite admission),\n* an angiotensin-converting enzyme inhibitor/angiotensin II receptor antagonist on the day of surgery,\n* secondary hypertension (e.g., renal artery stenosis, pheochromocytoma, Cushing's syndrome),\n* vascular disease,\n* poor cutaneous perfusion,\n* serious skin lesions\n* baseline temperature ≥37.5°C (degrees centigrade)"}, 'identificationModule': {'nctId': 'NCT01858727', 'briefTitle': 'The Effect of Preoperative Warming on Postoperative Hypothermia', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Diskapi Training and Research Hospital'}, 'officialTitle': 'The Effect of Preoperative Warming on Postoperative Hypothermia in TURP Surgery', 'orgStudyIdInfo': {'id': 'ESM0606'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'forced air warming group', 'description': '30 minutes before the preoperative will use forced air warming.', 'interventionNames': ['Other: forced air warming group', 'Other: control group']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'do not active heating group'}], 'interventions': [{'name': 'forced air warming group', 'type': 'OTHER', 'description': '30 minutes before the preoperative will use forced air warming', 'armGroupLabels': ['forced air warming group']}, {'name': 'control group', 'type': 'OTHER', 'description': 'do not heating group', 'armGroupLabels': ['forced air warming group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'Altindag', 'country': 'Turkey (Türkiye)', 'facility': 'Diskapi Teaching and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'fakelma 905327079113', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diskapi Teaching and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Diskapi Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. fatma kavak akelma', 'investigatorFullName': 'Fatma Kavak Akelma', 'investigatorAffiliation': "Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital"}}}}