Perioperative Active Warming Techniques in Colorectal Surgeries

NCT00913978 | Terminated Results FDA Device

• 1 other identifier: STU00202644
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

We propose a study in which we compare two intraoperative active warming devices for maintenance of normothermia in patients undergoing colorectal surgery. A novel underbody resistive warming mattress (VitaHeat) will be compared to the forced air warming blanket (3M Bair Hugger) that is currently used in our institution. Our hypothesis is that the underbody resistive warming mattress will be equally effective as forced air warming in maintaining normothermia in colorectal surgery.

Conditions

Normothermia

Keywords

Normothermia; Colorectal Surgery; Bair Huggers; VitaHeat

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Measure Will be the Percentage of Intraoperative Time the Participants Body Temperature is Above 36 Degrees Celcius.

  The total percent of intraoperative time (time in the operating room) that the body temperature of the participant is above 36 degrees celcius measured using an esophageal temperature probe.

  1 day

Secondary Outcomes (1)

• Post Operative Temperature on Admission to Post Operative Care Unit (PACU)

  Immediately after surgery

Study Arms (2)

Group 1: VitaHeat

ACTIVE COMPARATOR

Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room.

Device: Group 1: VitaHeat

Group 2: Bair Hugger

ACTIVE COMPARATOR

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.

Device: Group 2: Bair Hugger

Interventions

Group 1: VitaHeat DEVICE

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 1: VitaHeat

Group 2: Bair Hugger DEVICE

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.

Group 2: Bair Hugger

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years old undergoing laparoscopic or open colorectal surgical procedures under general anesthesia.

You may not qualify if:

• Any patient who is less than 18 years old.
• Emergent surgery
• Any patient with thyroid problems
• Any patient with preoperative fever
• Any patient who is pregnant
• Any adult patients unable to consent
• Prisoners

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (2)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (11)

• 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.

  PMID: 26775126 BACKGROUND

• 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.

  PMID: 19137809 BACKGROUND

• 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.

  PMID: 8317751 BACKGROUND

• 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.

  PMID: 8024134 BACKGROUND

• 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.

  PMID: 15114200 BACKGROUND

• 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.

  PMID: 11605926 BACKGROUND

• 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.

  PMID: 1610573 BACKGROUND

• 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.

  PMID: 15312013 BACKGROUND

• 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.

  PMID: 9702617 BACKGROUND

• 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.

  PMID: 12760996 BACKGROUND

• 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.

  PMID: 23989047 BACKGROUND

Limitations and Caveats

The limitation of the results presented is that we did not reach full enrollment as referenced in the protocol because the sponsor terminated the study early.

Results Point of Contact

• Title: Meltem Yilmaz, MD
• Organization: Northwestern University

m-yilmaz@northwestern.edu

312-695-0061

Study Officials

• Meltim Yilmaz, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Anesthesiology

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 4, 2009
• Study Start: April 13, 2017
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)