Perioperative Active Warming Techniques in Colorectal Surgeries
NCT ID: NCT00913978
Last Updated: 2020-01-13
Study Results
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View full resultsBasic Information
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TERMINATED
NA
50 participants
INTERVENTIONAL
2017-04-13
2018-12-21
Brief Summary
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Detailed Description
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Group 1: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut.
Group 2: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation.
Both groups will have IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
Participation in the study is voluntary. The patients may choose not to enroll in the research. Patients who choose not to enroll will use the standard forced air warmer.
Preoperative and postoperative temperatures will be measured orally. Intraoperative core and skin temperatures will be monitored continuously at 1 minute intervals using an esophageal probe and skin temperature probe using a skin temp probe placed on the great toe and covered to prevent any contact with the warming devices.
Intraoperative period: The participants temperature will be monitored and documented at prescribed times.
Postoperative period: The participants will have temperature monitored in the post anesthesia care area.
Participation in this study will last for 30 days following surgery at which point study member will call patient for a 2-4 minute phone call.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1: VitaHeat
Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room.
Group 1: VitaHeat
Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
Group 2: Bair Hugger
Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room.
Group 2: Bair Hugger
Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
Interventions
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Group 1: VitaHeat
Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
Group 2: Bair Hugger
Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation. IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Emergent surgery
* Any patient with thyroid problems
* Any patient with preoperative fever
* Any patient who is pregnant
* Any adult patients unable to consent
* Prisoners
18 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Meltem Yilmaz
Associate Professor in Anesthesiology
Principal Investigators
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Meltim Yilmaz, M.D.
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern Memorial Hospital
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Countries
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References
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Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.
Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006.
Sessler DI, Schroeder M. Heat loss in humans covered with cotton hospital blankets. Anesth Analg. 1993 Jul;77(1):73-7. doi: 10.1213/00000539-199307000-00014.
Cheney FW, Posner KL, Caplan RA, Gild WM. Burns from warming devices in anesthesia. A closed claims analysis. Anesthesiology. 1994 Apr;80(4):806-10. doi: 10.1097/00000542-199404000-00012.
Taguchi A, Ratnaraj J, Kabon B, Sharma N, Lenhardt R, Sessler DI, Kurz A. Effects of a circulating-water garment and forced-air warming on body heat content and core temperature. Anesthesiology. 2004 May;100(5):1058-64. doi: 10.1097/00000542-200405000-00005.
Janicki PK, Higgins MS, Janssen J, Johnson RF, Beattie C. Comparison of two different temperature maintenance strategies during open abdominal surgery: upper body forced-air warming versus whole body water garment. Anesthesiology. 2001 Oct;95(4):868-74. doi: 10.1097/00000542-200110000-00014.
Hynson JM, Sessler DI. Intraoperative warming therapies: a comparison of three devices. J Clin Anesth. 1992 May-Jun;4(3):194-9. doi: 10.1016/0952-8180(92)90064-8.
Brauer A, Weyland W, Kazmaier S, Trostdorf U, Textor Z, Hellige G, Braun U. Efficacy of postoperative rewarming after cardiac surgery. Ann Thorac Cardiovasc Surg. 2004 Jun;10(3):171-7.
Smith CE, Desai R, Glorioso V, Cooper A, Pinchak AC, Hagen KF. Preventing hypothermia: convective and intravenous fluid warming versus convective warming alone. J Clin Anesth. 1998 Aug;10(5):380-5. doi: 10.1016/s0952-8180(98)00049-x.
Negishi C, Hasegawa K, Mukai S, Nakagawa F, Ozaki M, Sessler DI. Resistive-heating and forced-air warming are comparably effective. Anesth Analg. 2003 Jun;96(6):1683-1687. doi: 10.1213/01.ANE.0000062770.73862.B7.
Melton GB, Vogel JD, Swenson BR, Remzi FH, Rothenberger DA, Wick EC. Continuous intraoperative temperature measurement and surgical site infection risk: analysis of anesthesia information system data in 1008 colorectal procedures. Ann Surg. 2013 Oct;258(4):606-12; discussion 612-3. doi: 10.1097/SLA.0b013e3182a4ec0f.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STU00202644
Identifier Type: -
Identifier Source: org_study_id
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