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NCT Number: NCT02518815

Preoperative Warming Prevents Postoperative Hypothermia in 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.

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Key information

Conditions

Hypothermia Following Anesthesia Body Temperature Changes Hypothermia Hypothermia Due to Anesthetic Hypothermia, Accidental Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Toronto East General Hospital

Toronto, Ontario, M4C 3E7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3M Bair Paws Warming System

Device

20 minutes of prewarming immediately pre-operatively using 3M Bair Paws warming system

Primary outcomes

  1. Oral temperature immediately postoperatively

    Time frame: Immediately post-operatively

    Immediate postoperative oral temperature on admission to the post-anesthetic care unit.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Michael Garron Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 10, 2015
Registry last updated
Aug 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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