The Effects of Ambient Temperature and Forced-air Warming on Intraoperative Core Temperature

April 22, 2021 updated by: Lijian Pei, Peking Union Medical College Hospital

The purpose of this study is to determine:

  1. the effect of ambient temperature on the rate of core temperature change from 1 to 3 hours after induction of anesthesia (linear phase of the hypothermia curve) in major operations lasting at least a couple of hours and
  2. whether the relationship between ambient temperature and rate of core temperature change is different for patients who are or are not warmed with forced-air.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Each patient will be randomly assigned to ambient temperature of 19°C, 21°C, or 23°C. Using a factorial approach, patients will also be randomly assigned to passive insulation or forced-air warming, stratified by the three types of surgery listed below. Group allocation will be based on computer generated codes (randomly permuted block sizes) prepared by Department of OUTCOMES RESEARCH statisticians using SAS statistical software. Allocation of consented patients to designated ambient temperature and forced-air vs. passive insulation will be via a web site that will be accessed by investigators in Bejing about 90 minutes before surgery.

Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. A lower-body cover (about 91 by 221 cm) will be positioned so the lower end of the forced-air segments extend from the ankles upward for the entire length of the cover in thoracic and abdominal cases. The cover's foot drape will extend over the feet, and in turn be covered by the surgical drape. An upper-body forced-air cover will similarly be applied for patients having hip arthroplasties. The forced-air cover will be connected to a Bair Hugger blower and #635 covers set to "high" (≈43°C).

Ambient temperature will be adjusted to the designated temperature about an hour before a patient enters the operating room and adjusted as necessary to maintain the designated temperature throughout surgery. General anesthesia will be induced as per usual clinical routine. Neuraxial (epidural or spinal) and other regional blocks are permitted.

Any patients whose core temperature decreases to less than 34.5°C will be actively warmed with forced air and the ambient temperature increases to the extent practical.

Study Type

Interventional

Enrollment (Actual)

292

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Dept. of Anesthesiology, PUMCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults scheduled for major open thoracic surgery or video assist thoracic surgery or major abdominal surgery under general anesthesia expected to last at least two hours

Exclusion Criteria:

  • Special risk for bleeding or myocardial infarction (as determined by the attending anesthesiologist)
  • Patients who would otherwise have been actively warmed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ambient Temp 19°C & Passive Insulation
Ambient Temperature 19°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.
Other: Ambient Temperature 19°C
Ambient Temperature 19°C
Other: Passive insulation
Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.
Experimental: Ambient Temp 19°C & Forced-air Warming
Ambient Temperature 19°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.
Other: Ambient Temperature 19°C
Ambient Temperature 19°C
Device: Forced-air cover (Bair hugger 63500, 3M)
Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.
Experimental: Ambient Temp 21°C & Passive Insulation
Ambient Temperature 21°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.
Other: Passive insulation
Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.
Other: Ambient Temperature 21°C
Ambient Temperature 21°C
Experimental: Ambient Temp 21°C & Forced-air Warming
Ambient Temperature 21°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.
Device: Forced-air cover (Bair hugger 63500, 3M)
Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.
Other: Ambient Temperature 21°C
Ambient Temperature 21°C
Experimental: Ambient Temp 23°C & Passive Insulation
Ambient Temperature 23°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.
Other: Passive insulation
Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.
Other: Ambient Temperature 23°C
Ambient Temperature 23°C
Experimental: Ambient Temp 23°C & Forced-air Warming
Ambient Temperature 23°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.
Device: Forced-air cover (Bair hugger 63500, 3M)
Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.
Other: Ambient Temperature 23°C
Ambient Temperature 23°C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Core Temperature Change
Time Frame: from 1 to 3 hours after induction of anesthesia
Rate of core temperature change from 1 to 3 hours after induction of anesthesia (°C/hour ) linear mixed-effects model to assess the effects of ambient temperature, forced-air warming and their interaction on the rate of core temperature change during 1 to 3h after induction
from 1 to 3 hours after induction of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

The Cleveland Clinic

Investigators

  • Principal Investigator: Lijian Pei, MD, Associate Prof. of Dept. of Anesthesiology, PUMCH
  • Study Chair: Yuguang Huang, MD, Chair of Dept. of Anesthesiology, PUMCH
  • Study Director: Daniel I Sessler, MD, Chair of Dept. of Outcomes Research, Anesthesiology Institute, Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (Estimate)

March 22, 2016

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ZS-878

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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