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

M

Michael Garron Hospital

Status

Completed

Conditions

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

Treatments

Device: 3M Bair Paws Warming System

Study type

Interventional

Funder types

Other

Identifiers

NCT02518815
550-1304-Mis-213

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

Female

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

42 participants in 2 patient groups

Prewarming group
Experimental group
Description:
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.
Treatment:
Device: 3M Bair Paws Warming System
Control group
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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