The Effect of Convective Pre-warming on Intra-operative Thermoregulatory Capabilities

NCT03876808 | Terminated Results FDA Device

• 1 other identifier: 2008755
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized clinical trial will assess the effect of pre-operative convective warming on intra-operative thermoregulation in patients undergoing gastrointestinal or genitourinary surgical procedures with the Tiger anesthesia perioperative protocol.

Conditions

Temperature Change, Body

Keywords

temperature; prewarming; convective warming; thermoregulation; gastrointestinal surgery; genitourinary surgery

Outcome Measures

Primary Outcomes (1)

• Core Body Temperature

  Change in core temperature between induction of anesthesia and end of skin preparation

  Day 1

Secondary Outcomes (3)

• Skin Temperature

  Day 1

• Intraoperative Temperatures

  Day 1

• Temperature Differences Between Different Age Groups

  Day 1

Study Arms (2)

Convective pre-warming

EXPERIMENTAL

Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room

Device: Bair Hugger™ Temperature Management Unit Model 750; Device: 3M™ Bair Paws™ Flex Gown

Standard of care

NO INTERVENTION

Undergo standard of care, which includes providing each patient with blankets and sheets, as well as more blankets on patient request.

Interventions

Bair Hugger™ Temperature Management Unit Model 750 DEVICE

Forced-air temperature management unit used for preoperative and intraoperative participant warming

Convective pre-warming

3M™ Bair Paws™ Flex Gown DEVICE

Bair Paws™ patient warming gown used for preoperative and intraoperative participant warming

Convective pre-warming

Eligibility Criteria

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

You may qualify if:

• ASA I-IV

You may not qualify if:

• Inability to obtain written informed consent
• Inability to obtain core body temperature recordings
• Family history of malignant hyperthermia
• Preoperative temperature \> 38° C

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University Hospital

Columbia, Missouri, 65212, United States

Location

Related Publications (14)

• Centers for Disease Control and Prevention. The state of aging and health in America 2013. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services, 2013.

  BACKGROUND

• Billeter AT, Hohmann SF, Druen D, Cannon R, Polk HC Jr. Unintentional perioperative hypothermia is associated with severe complications and high mortality in elective operations. Surgery. 2014 Nov;156(5):1245-52. doi: 10.1016/j.surg.2014.04.024. Epub 2014 Jun 16.

  PMID: 24947647 BACKGROUND

• Frank SM, Beattie C, Christopherson R, Norris EJ, Rock P, Parker S, Kimball AW Jr. Epidural versus general anesthesia, ambient operating room temperature, and patient age as predictors of inadvertent hypothermia. Anesthesiology. 1992 Aug;77(2):252-7. doi: 10.1097/00000542-199208000-00005.

  PMID: 1642343 BACKGROUND

• Sessler, Daniel I. Chapter 8: preoperative thermoregulation. Geriatric Anesthesia, 2nd ed., Springer, New York, NY: 107-118, 2008.

  BACKGROUND

• Glosten B, Hynson J, Sessler DI, McGuire J. Preanesthetic skin-surface warming reduces redistribution hypothermia caused by epidural block. Anesth Analg. 1993 Sep;77(3):488-93. doi: 10.1213/00000539-199309000-00012.

  PMID: 8368549 BACKGROUND

• Kurz A, Plattner O, Sessler DI, Huemer G, Redl G, Lackner F. The threshold for thermoregulatory vasoconstriction during nitrous oxide/isoflurane anesthesia is lower in elderly than in young patients. Anesthesiology. 1993 Sep;79(3):465-9. doi: 10.1097/00000542-199309000-00008.

  PMID: 8363070 BACKGROUND

• Ozaki M, Sessler DI, Matsukawa T, Ozaki K, Atarashi K, Negishi C, Suzuki H. The threshold for thermoregulatory vasoconstriction during nitrous oxide/sevoflurane anesthesia is reduced in the elderly. Anesth Analg. 1997 May;84(5):1029-33. doi: 10.1097/00000539-199705000-00014.

  PMID: 9141926 BACKGROUND

• Kim JY, Shinn H, Oh YJ, Hong YW, Kwak HJ, Kwak YL. The effect of skin surface warming during anesthesia preparation on preventing redistribution hypothermia in the early operative period of off-pump coronary artery bypass surgery. Eur J Cardiothorac Surg. 2006 Mar;29(3):343-7. doi: 10.1016/j.ejcts.2005.12.020. Epub 2006 Jan 24.

  PMID: 16434206 BACKGROUND

• Perl T, Peichl LH, Reyntjens K, Deblaere I, Zaballos JM, Brauer A. Efficacy of a novel prewarming system in the prevention of perioperative hypothermia. A prospective, randomized, multicenter study. Minerva Anestesiol. 2014 Apr;80(4):436-43. Epub 2013 Oct 3.

  PMID: 24193180 BACKGROUND

• Horn EP, Bein B, Bohm R, Steinfath M, Sahili N, Hocker J. The effect of short time periods of pre-operative warming in the prevention of peri-operative hypothermia. Anaesthesia. 2012 Jun;67(6):612-7. doi: 10.1111/j.1365-2044.2012.07073.x. Epub 2012 Feb 29.

  PMID: 22376088 BACKGROUND

• Torossian A, Van Gerven E, Geertsen K, Horn B, Van de Velde M, Raeder J. Active perioperative patient warming using a self-warming blanket (BARRIER EasyWarm) is superior to passive thermal insulation: a multinational, multicenter, randomized trial. J Clin Anesth. 2016 Nov;34:547-54. doi: 10.1016/j.jclinane.2016.06.030. Epub 2016 Jul 17.

  PMID: 27687449 BACKGROUND

• Vanni SM, Braz JR, Modolo NS, Amorim RB, Rodrigues GR Jr. Preoperative combined with intraoperative skin-surface warming avoids hypothermia caused by general anesthesia and surgery. J Clin Anesth. 2003 Mar;15(2):119-25. doi: 10.1016/s0952-8180(02)00512-3.

  PMID: 12719051 BACKGROUND

• Jo YY, Chang YJ, Kim YB, Lee S, Kwak HJ. Effect of Preoperative Forced-Air Warming on Hypothermia in Elderly Patients Undergoing Transurethral Resection of the Prostate. Urol J. 2015 Nov 14;12(5):2366-70.

  PMID: 26571323 BACKGROUND

• Sessler DI, Schroeder M, Merrifield B, Matsukawa T, Cheng C. Optimal duration and temperature of prewarming. Anesthesiology. 1995 Mar;82(3):674-81. doi: 10.1097/00000542-199503000-00009.

  PMID: 7879936 BACKGROUND

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination due to low subject recruitment leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. Boris Mraovic, Professor of Clinical Anesthesiology
• Organization: University of Missouri - Columbia

mraovicb@health.missouri.edu

573-882-2568

Study Officials

• Boris Mraovic, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: At time of consent the randomization is masked for the participant, care provider, and investigator. Once randomization has occurred there is no masking as you clearly know what group has been assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 15, 2019
• Study Start: October 26, 2017
• Primary Completion: November 7, 2018
• Study Completion: November 7, 2018
• Last Updated: October 2, 2023
• Results First Posted: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)