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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715076
Recruitment Status : Unknown
Verified March 2016 by Lijian Pei, Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : March 22, 2016
Last Update Posted : March 22, 2016
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Lijian Pei, Peking Union Medical College Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Major Surgery Under General Anesthesia Other: Ambient Temperature 19°C Other: Ambient Temperature 21°C Other: Ambient Temperature 23°C Device: Forced-air cover (Bair hugger 63500, 3M) Other: Passive insulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 394 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of Ambient Temperature and Forced-air Warming on Intraoperative Core Temperature
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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: Ambient Temperature 21°C
Ambient Temperature 21°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 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.
Other: Ambient Temperature 21°C
Ambient Temperature 21°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 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: Ambient Temperature 23°C
Ambient Temperature 23°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 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.
Other: Ambient Temperature 23°C
Ambient Temperature 23°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.




Primary Outcome Measures :
  1. 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 )


Secondary Outcome Measures :
  1. Redistribution hypothermia [ Time Frame: during the first hour after induction of anesthesia ]
    Decrease in core temperature during the first hour after induction of anesthesia (°C)

  2. Final intraoperative core temperature [ Time Frame: intraoperative ]
    Final intraoperative core temperature at the end of anesthesia (°C)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715076


Contacts
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Contact: LiJian Pei, MD +86 10 65294278 hazelbeijing@vip.163.com

Locations
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China
Dept. of Anesthesiology, PUMCH Recruiting
Beijing, China, 100730
Contact: LiJian Pei, MD    +86 10 65294278    hazelbeijing@vip.163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
The Cleveland Clinic
Investigators
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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:

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Responsible Party: Lijian Pei, Associate Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02715076    
Other Study ID Numbers: ZS-878
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lijian Pei, Peking Union Medical College Hospital:
Thoracic Surgery
Thoracic surgery, Video assisted
Open Abdominal Surgery
Anesthesia, General