Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT02416557
Status:
UNKNOWN
Last Update Posted:
2015-04-15
First Post:
2015-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of PEEP on Intraoperative Hypothermia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013122', 'term': 'Spinal Diseases'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-09', 'studyFirstSubmitDate': '2015-04-06', 'studyFirstSubmitQcDate': '2015-04-09', 'lastUpdatePostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body temperature as assessed by esophageal temperature probe', 'timeFrame': '180 minutes after the completion of anesthesia induction', 'description': 'Body temperature is assessed by esophageal temperature probe. The investigators used body temperature at 180 minutes after anesthesia induction as a primary outcome'}], 'secondaryOutcomes': [{'measure': 'Thermoregulatory vasoconstriction threshold', 'timeFrame': 'until 180 minutes after the completion of anesthesia induction', 'description': 'The time of the difference in skin temperature between forearm and fingertip becoming zero.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Diseases']}, 'referencesModule': {'references': [{'pmid': '25107714', 'type': 'BACKGROUND', 'citation': 'Yamasaki H, Tanaka K, Funai Y, Suehiro K, Ikenaga K, Mori T, Osugi H, Nishikawa K. The impact of intraoperative hypothermia on early postoperative adverse events after radical esophagectomy for cancer: a retrospective cohort study. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):943-7. doi: 10.1053/j.jvca.2014.02.013.'}, {'pmid': '11004013', 'type': 'BACKGROUND', 'citation': 'Nakajima Y, Mizobe T, Takamata A, Tanaka Y. Baroreflex modulation of peripheral vasoconstriction during progressive hypothermia in anesthetized humans. Am J Physiol Regul Integr Comp Physiol. 2000 Oct;279(4):R1430-6. doi: 10.1152/ajpregu.2000.279.4.R1430.'}, {'pmid': '25097736', 'type': 'BACKGROUND', 'citation': 'Jung KT, Kim SH, Lee HY, Jung JD, Yu BS, Lim KJ, So KY, Lee JY, An TH. Effect on thermoregulatory responses in patients undergoing a tympanoplasty in accordance to the anesthetic techniques during PEEP: a comparison between inhalation anesthesia with desflurane and TIVA. Korean J Anesthesiol. 2014 Jul;67(1):32-7. doi: 10.4097/kjae.2014.67.1.32. Epub 2014 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'Intraoperative hypothermia is associated with many clinical adverse outcomes. Many techniques were applied to prevent intraoperative hypothermia, and positive end-expiratory pressure (PEEP) has been known to blunt intraoperative hypothermia by increasing thermoregulatory vasoconstriction threshold. The investigators assessed the effect of PEEP on the prevention of intraoperative hypothermia during spine surgery in prone position.', 'detailedDescription': 'It is well known that intraoperative hypothermia is associated with postoperative adverse clinical outcomes in various study populations. Intraoperative hypothermia has various adverse effects including impaired drug clearance, cold diuresis and hypovolemia, immunosuppression with increased infection risk, electrolyte disorders, coagulopathy with impaired platelet function, negative nitrogen balance, shivering, insulin resistance, and myocardial events. Numerous methods have been introduced to prevent intraoperative hypothermia, such as warming of infusion fluid, forced-air warming, heat-pads, heated water mattress, and heated humidifiers. However, in patients undergoing lumbar spine surgery in the prone position, these methods to prevent intraoperative hypothermia may partially effective because these methods, in clinical practice, have a significant limitation in their application.\n\nPositive end-expiratory pressure (PEEP) reduces the venous return by increasing intrathoracic pressure. This causes carotid unloading, which leads to a secondary peripheral vasoconstriction by increasing thermoregulatory vasoconstriction threshold and blunts intraoperative hypothermia. Previous studies demonstrated that intraoperative PEEP significantly attenuated the extent of intraoperative hypothermia in patients undergoing tympanoplasty. However, the beneficial effect of PEEP on thermoregulation is not investigated in patients with the prone position for spinal surgery.\n\nThe investigators hypothesized that PEEP can reduce the extent of intraoperative hypothermia via thermoregulatory modulation. In this study, the investigators investigated the effect of PEEP on intraoperative core body temperature and the incidence of intraoperative hypothermia in patients undergoing spinal surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were scheduled for elective spine surgery requiring more than 3 hours\n\nExclusion Criteria:\n\n* Patients who do not agree to the study\n* Patients with or American Society of Anesthesiologists (ASA) physical status class 3 or more\n* Patients with thyroid disease, peripheral vascular diseases, uncontrolled diabetes or hypertension\n* Patients with morbid obesity (BMI \\>35 kg/m2)\n* Patients with clinically severe pulmonary disease\n* Patients undergoing simultaneous anterior and posterior lumbar fusion surgery were also excluded.\n* Patients with taking non-steroidal anti-inflammatory drug within two weeks\n* Patients with preoperative fever or hypothermia\n* Patients with intraoperative intentional hypothermia for neuroprotection'}, 'identificationModule': {'nctId': 'NCT02416557', 'briefTitle': 'Effect of PEEP on Intraoperative Hypothermia', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effect of Positive End Expiratory Pressure on Intraoperative Body Temperature in Patients Undergoing Spine Surgery; a Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'Intraoperative hypothermia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group P', 'description': 'Patients using positive end-expiratory pressure (PEEP) of 10 cmH2O (centimeter of water) intraoperatively', 'interventionNames': ['Procedure: PEEP']}, {'type': 'NO_INTERVENTION', 'label': 'Group C', 'description': 'Patients using no positive end-expiratory pressure (zero PEEP) intraoperatively'}], 'interventions': [{'name': 'PEEP', 'type': 'PROCEDURE', 'otherNames': ['positive end expiratory pressure'], 'description': 'application of 10 cmH2O (centimeter of water) positive end expiratory pressure during mechanical ventilation', 'armGroupLabels': ['Group P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-799', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University of Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hee Pyung Park, MD PhD', 'role': 'CONTACT', 'email': 'hppark@snu.ac.kr', 'phone': '82-2-2072-2466'}, {'name': 'Hyungseok Seo, MD', 'role': 'CONTACT', 'email': 'seohyungseok@gmail.com', 'phone': '82-2072-2469'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}