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

Primary Purpose

Temperature Change, Body

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bair Hugger™ Temperature Management Unit Model 750
3M™ Bair Paws™ Flex Gown
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temperature Change, Body focused on measuring temperature, prewarming, convective warming, thermoregulation, gastrointestinal surgery, genitourinary surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I-IV
  • Other inclusion criteria as delineated in the TIGER anesthesia perioperative protocol

Exclusion Criteria:

  • Inability to obtain written informed consent
  • Inability to obtain core body temperature recordings
  • Family history of malignant hyperthermia
  • Preoperative temperature > 38° C
  • Other exclusion criteria as delineated in the TIGER anesthesia perioperative protocol

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Convective pre-warming

Standard of care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Skin Temperature
Change in skin temperature between arrival to the holding area and departure to the operating room, and arrival to the PACU
Intraoperative Temperatures
Core body temperature measured intraoperatively
Temperature Differences Between Different Age Groups
Differences in temperature changes between elderly (≥ 65 years) and younger patients (< 65 years).

Full Information

First Posted
March 13, 2019
Last Updated
September 29, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03876808
Brief Title
The Effect of Convective Pre-warming on Intra-operative Thermoregulatory Capabilities
Official Title
A Prospective Randomized Clinical Trial Evaluating the Effect of Convective Pre-warming on Intra-operative Thermoregulatory Capabilities in Patients Enrolled in the TIGER Anesthesia Perioperative Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Poor participant recruitment
Study Start Date
October 26, 2017 (Actual)
Primary Completion Date
November 7, 2018 (Actual)
Study Completion Date
November 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
By the year 2030 the geriatric presence in the United States, defined as any adult >65 years of age, is estimated to reach around 20% of the entire population. Thus, understanding medical concepts as they relate to the elderly is becoming increasingly important. One such concept is that of hypothermia - a core body temperature < 36°C - for which age >65 has been found to be an independent risk factor. This complication is especially prevalent intra-operatively due to use of general anesthetics, cool ambient operating room (OR) temperatures, and impaired thermal regulation in the elderly. The human body employs numerous mechanisms to maintain thermal homeostasis including: behavioral means of thermoregulation, sweating, pre-capillary vasodilation, non-shivering and shivering means of heat production, and arteriovenous shunt vasoconstriction. The first, and arguably most important, regulatory response to occur is that of vasoconstriction, which normally results in redistribution of blood from the relatively cool periphery to the warmer core compartment in order to confine metabolic heat to the central tissues. Patients undergoing general anesthesia experience reduced vasoconstriction due to decreased cold response thresholds while patients undergoing epidural anesthesia experience sympathetic blocks resulting in blunted vasoconstrictive responses. All patients experience the afore mentioned side effects of anesthetics, however it has been proven that the elderly are more susceptible to hypothermia due to lower vasoconstriction thresholds - determined by a temperature gradient of 4°C between the periphery and core. First explored by Kurz et al. in 1993, it was found that use of nitrous oxide and isoflurane anesthesia lead to an approximately 1.2°C lower vasoconstriction threshold of 33.9±0.6 in the elderly versus 35.1±0.3 in the young (p < .01). This subject was again looked at in a 1997 study wherein the vasoconstriction threshold during nitrous oxide and sevoflurane was observed to be decreased by approximately 0.8°C in the elderly at 35.0±0.8 versus 35.8±0.3 in the young (p < .01). This is relevant because intraoperative hypothermia has long been known to lead to adverse outcomes such as increased incidence of myocardial ischemia, arrhythmias, coagulopathic states, and wound infections. In a 2014 retrospective cohort study by Billeter et al. patient's experiencing core temperatures <35°C had a four times increase in mortality with complication rates increasing two fold and incidence of stroke increasing six fold. To counter this thermoregulatory failure in patients, numerous methods of warming have been practiced over time to augment the normal body response. One method used to decrease intraoperative hypothermia is warming patients before surgery via skin surface warmers. Numerous studies have found that even brief periods of pre-warming can improve intraoperative temperatures significantly for as long as 75-90 minutes after induction. In procedures lasting less than 90 minutes, Horn et al. found that as little as 10 minutes of pre-warming decreased incidence of intraoperative hypothermia from 69% to just 13% while Torossian et al. decreased the incidence from 60% to 38% in his study using a self-warming blanket for 30 minutes pre-operatively. Studies have also shown that longer pre-warming, of 45-60 minutes, can prevent hypothermia for up to 2 hours after induction. While significant research has been performed on the effects of warming patients before they undergo surgical procedures, scant evidence demonstrates the effect of pre-warming in the elderly. In one article specifically looking at pre-warming in the elderly (mean age ~72-73) it was found that, after pre-warming for 20 minutes, there was no significant change in incidence of hypothermia but there was a significant difference in severity of hypothermia when it did occur. This study focused only on men undergoing transurethral resection of the prostate however, and suffers from lack of generalizability. With the proportion of the geriatric population continuing to expand, and the potential adverse effects resulting from their increased susceptibility to intraoperative hypothermia, it is of the utmost importance to look into methods to counter this dilemma and expand the database on the topic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temperature Change, Body
Keywords
temperature, prewarming, convective warming, thermoregulation, gastrointestinal surgery, genitourinary surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Convective pre-warming
Arm Type
Experimental
Arm Description
Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Undergo standard of care, which includes providing each patient with blankets and sheets, as well as more blankets on patient request.
Intervention Type
Device
Intervention Name(s)
Bair Hugger™ Temperature Management Unit Model 750
Intervention Description
Forced-air temperature management unit used for preoperative and intraoperative participant warming
Intervention Type
Device
Intervention Name(s)
3M™ Bair Paws™ Flex Gown
Intervention Description
Bair Paws™ patient warming gown used for preoperative and intraoperative participant warming
Primary Outcome Measure Information:
Title
Core Body Temperature
Description
Change in core temperature between induction of anesthesia and end of skin preparation
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Skin Temperature
Description
Change in skin temperature between arrival to the holding area and departure to the operating room, and arrival to the PACU
Time Frame
Day 1
Title
Intraoperative Temperatures
Description
Core body temperature measured intraoperatively
Time Frame
Day 1
Title
Temperature Differences Between Different Age Groups
Description
Differences in temperature changes between elderly (≥ 65 years) and younger patients (< 65 years).
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I-IV Other inclusion criteria as delineated in the TIGER anesthesia perioperative protocol Exclusion Criteria: Inability to obtain written informed consent Inability to obtain core body temperature recordings Family history of malignant hyperthermia Preoperative temperature > 38° C Other exclusion criteria as delineated in the TIGER anesthesia perioperative protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Mraovic, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
24947647
Citation
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.
Results Reference
background
PubMed Identifier
1642343
Citation
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.
Results Reference
background
Citation
Sessler, Daniel I. Chapter 8: preoperative thermoregulation. Geriatric Anesthesia, 2nd ed., Springer, New York, NY: 107-118, 2008.
Results Reference
background
PubMed Identifier
8368549
Citation
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.
Results Reference
background
PubMed Identifier
8363070
Citation
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.
Results Reference
background
PubMed Identifier
9141926
Citation
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.
Results Reference
background
PubMed Identifier
16434206
Citation
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.
Results Reference
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PubMed Identifier
24193180
Citation
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.
Results Reference
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PubMed Identifier
22376088
Citation
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.
Results Reference
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PubMed Identifier
27687449
Citation
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.
Results Reference
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PubMed Identifier
12719051
Citation
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.
Results Reference
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PubMed Identifier
26571323
Citation
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.
Results Reference
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7879936
Citation
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.
Results Reference
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The Effect of Convective Pre-warming on Intra-operative Thermoregulatory Capabilities

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