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

Not Applicable

Completed

• Conditions: Hypothermia Following Anesthesia; Hypothermia; Hypothermia, Accidental; Body Temperature Changes; Hypothermia Due to Anesthetic
• Interventions: Device: 3M Bair Paws Warming System

• Registration Number: NCT02518815
• Lead Sponsor: Michael Garron Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2013-05
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2015-07-22
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-05
• Last Update Submitted: 2015-08-05
• Study First Posted: 2015-08-10
• Last Update Posted: 2015-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prewarming group	3M Bair Paws Warming System	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.

Primary Outcome Measures

Name	Time	Method
Oral temperature immediately postoperatively	Immediately post-operatively	Immediate postoperative oral temperature on admission to the post-anesthetic care unit.

Secondary Outcome Measures

Name	Time	Method
Oral temperature at discharge from post-anesthetic care unit	Discharge from post-anesthetic care unit (average 99 minutes)	Oral temperature upon discharge from the post-anesthetic care unit.
11-point Pain score	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
Oral temperature 30 minutes postoperatively	30 min after admission to post-anesthetic care unit	Oral temperature 30 minutes after admission to the post-anesthetic care unit.

Trial Locations

Locations (1)

Toronto East General Hospital; 🇨🇦 Toronto, Ontario, Canada