Preoperative Warming Prevents Postoperative Hypothermia in Laparoscopic Gynecologic Surgery. A Randomized Control Trial
Primary Purpose
Hypothermia Following Anesthesia, Hypothermia, Hypothermia, Accidental
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
3M Bair Paws Warming System
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia Following Anesthesia
Eligibility Criteria
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
Sites / Locations
- Toronto East General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Prewarming group
Control group
Arm 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.
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.
Outcomes
Primary Outcome Measures
Oral temperature immediately postoperatively
Immediate postoperative oral temperature on admission to the post-anesthetic care unit.
Secondary Outcome Measures
Oral temperature 30 minutes postoperatively
Oral temperature 30 minutes after admission to the post-anesthetic care unit.
Oral temperature at discharge from post-anesthetic care unit
Oral temperature upon discharge from the post-anesthetic care unit.
11-point Pain score
11-point VAS pain score postoperatively measured 30 minutes after admission to the post-anesthetic care unit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02518815
Brief Title
Preoperative Warming Prevents Postoperative Hypothermia in Laparoscopic Gynecologic Surgery. A Randomized Control Trial
Official Title
Preoperative Active Warming Prevents Postoperative Hypothermia in Patients Undergoing Laparoscopic Gynecologic Surgery. A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Michael Garron Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia Following Anesthesia, Hypothermia, Hypothermia, Accidental, Body Temperature Changes, Hypothermia Due to Anesthetic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prewarming group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
3M Bair Paws Warming System
Intervention Description
20 minutes of prewarming immediately pre-operatively using 3M Bair Paws warming system
Primary Outcome Measure Information:
Title
Oral temperature immediately postoperatively
Description
Immediate postoperative oral temperature on admission to the post-anesthetic care unit.
Time Frame
Immediately post-operatively
Secondary Outcome Measure Information:
Title
Oral temperature 30 minutes postoperatively
Description
Oral temperature 30 minutes after admission to the post-anesthetic care unit.
Time Frame
30 min after admission to post-anesthetic care unit
Title
Oral temperature at discharge from post-anesthetic care unit
Description
Oral temperature upon discharge from the post-anesthetic care unit.
Time Frame
Discharge from post-anesthetic care unit (average 99 minutes)
Title
11-point Pain score
Description
11-point VAS pain score postoperatively measured 30 minutes after admission to the post-anesthetic care unit
Time Frame
30 min after admission to post-anesthetic care unit
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Kulchyk, MD
Organizational Affiliation
Michael Garron Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto East General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
12. IPD Sharing Statement
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Preoperative Warming Prevents Postoperative Hypothermia in Laparoscopic Gynecologic Surgery. A Randomized Control Trial
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