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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypothermia Following Anesthesia, Hypothermia, Hypothermia, Accidental, Body Temperature Changes, Hypothermia Due to Anesthetic

Intervention / Treatment
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* Device: 3M Bair Paws Warming System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prewarming group<br>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<br>* 20 minutes of prewarming immediately pre-operatively using 3M Bair Paws warming system<br>|
| No Intervention: Control group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral temperature immediately postoperatively | 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 | 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 | Oral temperature upon discharge from the post-anesthetic care unit. | Discharge from post-anesthetic care unit (average 99 minutes) | 
| 11-point Pain score | 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 |