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

NCT02715076 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2021-05-11

Study results available
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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.

Conditions

  • Major Surgery Under General Anesthesia

Interventions

OTHER

Ambient Temperature 19°C

Ambient Temperature 19°C

OTHER

Ambient Temperature 21°C

Ambient Temperature 21°C

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.

OTHER

Passive insulation

Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • LiJian Pei, MD · Associate Prof. of Dept. of Anesthesiology, PUMCH

  • Yuguang Huang, MD · Chair of Dept. of Anesthesiology, PUMCH

  • Daniel I Sessler, MD · Chair of Dept. of Outcomes Research, Anesthesiology Institute, Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02715076 on ClinicalTrials.gov