Preoperative Warming Prevents Postoperative Hypothermia in Laparoscopic Gynecologic Surgery. A Randomized Control Trial

August 5, 2015 updated by: Michael Garron Hospital

Preoperative Active Warming Prevents Postoperative Hypothermia in Patients Undergoing Laparoscopic Gynecologic Surgery. A Randomized Control Trial

This study examined whether 20 minutes of prewarming prior to gynecological laparoscopic surgery prevented inadvertent post-operative hypothermia. Treatment group received prewarming using a forced air body warming, control group received no active warming system. Both groups were then warmed with forced air warmer intraoperatively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inadvertent perioperative hypothermia is a well known perioperative complication. The behavioural response to hypothermia is the most powerful protective tool, more effective than any autonomic response, and is obviously removed in the operative setting. Anesthesia alters thermoregulation by profoundly changing the thresholds for vasoconstriction and shivering, making patients vulnerable to the adverse outcomes related to mild hypothermia. Inadvertent postoperative hypothermia can occur in up to 70% of surgical patients. It is defined as a core temperature below 36°C (96.8°F). The aim of this study was to determine if prewarming with an active warming system for 20 minutes preoperatively could prevent postoperative inadvertent hypothermia.

Study Type

Interventional

Enrollment (Actual)

42

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA I-III
  • undergoing elective laparoscopic gynecological surgical procedures
  • expected duration >60 minutes
  • BMI 18-45

Exclusion Criteria:

  • Current fever (temperature>38.1°C)
  • active endocrine disorders were exclusion criteria

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prewarming group
Prewarmed for 20 minutes prior to OR using 3M Bair Paws System, a forced air warming blanket. This warming blanket was then used intraoperatively throughout the case.
Device: 3M Bair Paws Warming System
20 minutes of prewarming immediately pre-operatively using 3M Bair Paws warming system
No Intervention: Control group
Patients received standard care, which is no active prewarming prior to OR. A full body, forced air warming blanket (same as treatment group) was used intraoperatively throughout the case.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral temperature immediately postoperatively
Time Frame: Immediately post-operatively
Immediate postoperative oral temperature on admission to the post-anesthetic care unit.
Immediately post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral temperature 30 minutes postoperatively
Time Frame: 30 min after admission to post-anesthetic care unit
Oral temperature 30 minutes after admission to the post-anesthetic care unit.
30 min after admission to post-anesthetic care unit
Oral temperature at discharge from post-anesthetic care unit
Time Frame: Discharge from post-anesthetic care unit (average 99 minutes)
Oral temperature upon discharge from the post-anesthetic care unit.
Discharge from post-anesthetic care unit (average 99 minutes)
11-point Pain score
Time Frame: 30 min after admission to post-anesthetic care unit
11-point VAS pain score postoperatively measured 30 minutes after admission to the post-anesthetic care unit
30 min after admission to post-anesthetic care unit

Collaborators and Investigators

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

Sponsor

Michael Garron Hospital

Investigators

  • Principal Investigator: James Kulchyk, MD, Michael Garron Hospital

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

May 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 22, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimate)

August 10, 2015

Study Record Updates

Last Update Posted (Estimate)

August 10, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 550-1304-Mis-213

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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