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Comparison of Active Prewarming Versus Standard Care to Prevent Perioperative Hyporthermia in Short Outpatient Surgery Under General Anesthesia (PREWARMING)

Primary Purpose

Hypothermia Following Anesthesia, Hypothermia, Accidental

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Active Prewarming
Standard Care
Sponsored by
Ciusss de L'Est de l'Île de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia Following Anesthesia focused on measuring Outpatient Surgeries, Short Surgeries, Active Prewarming

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA Physical Status I to III
  • Elective Outpatient Surgery under General Anesthesia
  • Surgery Length from 30 to 120 minutes (from induction of anesthesia to extubation)

Exclusion Criteria:

  • Patient refusal or inability to consent
  • Neuraxial (spinal or epidural) anesthesia
  • BMI over 40 (Flex gown limitation)
  • Pregnancy
  • Active infection
  • Systemic disease which impairs thermoregulation (hypothyroidism or hyperthyroidism, adrenal insufficiency, major burns, para / quadriplegia)
  • Medications affecting core body temperature (like levothyroxine)
  • Facial surgery
  • Use of a fluid warmer

Sites / Locations

  • CIUSSS de l'Est de l'Ile de Montreal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Prewarming group (PW group)

Control group (C group)

Arm Description

Group randomized to receive at least 30 minutes of active prewarming before induction of anesthesia, combined to active warming intraoperatively.

Group randomized to receive the standard care : passive prewarming before induction of anesthesia combined to active warming intraoperatively.

Outcomes

Primary Outcome Measures

Temperature at the end of surgery (°Celsius)
Patient Temperature at the end of surgery

Secondary Outcome Measures

Incidence of Hypothermia (presence or absence)
Incidence of hypothermia, defined as a core body temperature below 36°Celsius
Delta Temperature Loss (°Celsius)
Maximum Temperature Loss intraoperatively (from the temperature at entry in the operating room to the minimum temperature reached during surgery )
Shivering incidence (number of episodes)
Number of shivering episodes at the recovery room
Grade of Shivering (likert scale 0 to 4)
Grade of Shivering according to Crossley and Mahajan grading scale of intraoperative shivering (from 0 to 4)
Recovery Room Length of Stay (minutes)
Length of Stay in the Recovery Room
Patient Comfort Level (likert scale 0 to 10)
Evaluation of the Patient's Thermal Comfort Level according to a verbal numerical rating scale (from 0 - extremely uncomfortable ; to 10 - extremely comfortable)

Full Information

First Posted
October 20, 2020
Last Updated
October 1, 2021
Sponsor
Ciusss de L'Est de l'Île de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT04601636
Brief Title
Comparison of Active Prewarming Versus Standard Care to Prevent Perioperative Hyporthermia in Short Outpatient Surgery Under General Anesthesia
Acronym
PREWARMING
Official Title
Comparison of Continuous Active Prewarming Using Flex Warming Gown (3M) Versus Standard Care to Prevent Perioperative Hyporthermia in Short Outpatient Surgery Under General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ciusss de L'Est de l'Île de Montréal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this prospective randomized controlled study is to compare the efficiency in preventing perioperative hypothermia of a continuous active prewarming combined with active intraoperative warming versus passive prewarming plus intraoperative warming for short outpatient surgery.
Detailed Description
The prevalence of accidental perioperative hypothermia is high, ranging from 20 to 90% in the literature, and its prevention still remains a major issue despite the many existing prevention techniques. Perioperative hypothermia is defined as a core body temperature below 36.0 ° Celsius. The deleterious effects of perioperative hypothermia are well known : increased risk of wound infection, adverse cardiac events and blood loss. Moreover, the pharmacology of anesthetic agents can be altered by hypothermia, which in turn could lengthen the emergence of anesthesia. Patient comfort and satisfaction are also related to hypothermia and the feeling of cold generated. Thus, hypothermia may be associated with prolonged length of stay in the recovery room and in the hospital for outpatient surgeries. Therefore, hypothermia can indirectly increase the costs of an intervention. Several techniques have been described for the prevention of perioperative hypothermia. Passive warming is a method used to prevent heat loss such as warm cotton blankets, drapes or plastics whereas active warming consist in adding heat to the body surface using a warming system such as forced-air warming to increase mean body temperature. So, the use of a prewarming, an active warming before induction of anesthesia, could reduce the potential for redistribution, the main mechanism of hypothermia under general anesthesia. Based on a literature review, the combined use of active prewarming with intraoperative active warming appears to be the most effective technique in preventing hypothermia upon arrival in the recovery room for inpatient surgeries lasting longer than 30 minutes. In the literature, the majority of publications on prewarming focus on surgeries lasting at least one hour, despite strong recommendations to use active warming for surgeries of 30 minutes or more. There is not so much data regarding the efficiency of continuous prewarming for short outpatient surgeries, from the preoperative unit to induction of anesthesia. This prospective randomized controlled study is designed to evaluate if the combination of a continuous active prewarming of at least 30 minutes (Flex Warming Gown, Bair Paws, 3M) with an active intraoperative warming (Bair Hugger, 3M) would be effective in demonstrating a significant difference in temperature at the end of surgery between the two groups (control and intervention) for short (30 to 120 minutes) outpatient surgeries under general anesthesia. This intervention will be compared to the standard care which are a passive warming preoperatively with an active intraoperative warming.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia Following Anesthesia, Hypothermia, Accidental
Keywords
Outpatient Surgeries, Short Surgeries, Active Prewarming

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Prewarming group (PW group)
Arm Type
Active Comparator
Arm Description
Group randomized to receive at least 30 minutes of active prewarming before induction of anesthesia, combined to active warming intraoperatively.
Arm Title
Control group (C group)
Arm Type
Placebo Comparator
Arm Description
Group randomized to receive the standard care : passive prewarming before induction of anesthesia combined to active warming intraoperatively.
Intervention Type
Device
Intervention Name(s)
Active Prewarming
Intervention Description
Active prewarming with Flex Warming Gown (Bair Paws, 3M) for at least 30 minutes before induction of anesthesia, with active warming intraoperatively with Bair Hugger (3M)
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Standard care with a passive prewarming (warm cotton blankets) before induction of anesthesia, with active warming intraoperatively with (Bair Hugger, 3M)
Primary Outcome Measure Information:
Title
Temperature at the end of surgery (°Celsius)
Description
Patient Temperature at the end of surgery
Time Frame
Measure taken at the end of surgery, before the patient leaves the operating room for the recovery room (below 120 minutes)
Secondary Outcome Measure Information:
Title
Incidence of Hypothermia (presence or absence)
Description
Incidence of hypothermia, defined as a core body temperature below 36°Celsius
Time Frame
Intraoperative (time frame when patient is in the operative room - below 120 minutes)
Title
Delta Temperature Loss (°Celsius)
Description
Maximum Temperature Loss intraoperatively (from the temperature at entry in the operating room to the minimum temperature reached during surgery )
Time Frame
Intraoperative (time frame when patient is in the operative room - below 120 minutes)
Title
Shivering incidence (number of episodes)
Description
Number of shivering episodes at the recovery room
Time Frame
Length of Stay in the Recovery Room (maximum 2h)
Title
Grade of Shivering (likert scale 0 to 4)
Description
Grade of Shivering according to Crossley and Mahajan grading scale of intraoperative shivering (from 0 to 4)
Time Frame
Length of Stay in the Recovery Room (maximum 2h)
Title
Recovery Room Length of Stay (minutes)
Description
Length of Stay in the Recovery Room
Time Frame
Length of Stay in the Recovery Room (maximum 2h)
Title
Patient Comfort Level (likert scale 0 to 10)
Description
Evaluation of the Patient's Thermal Comfort Level according to a verbal numerical rating scale (from 0 - extremely uncomfortable ; to 10 - extremely comfortable)
Time Frame
Right before entry in the operating room

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA Physical Status I to III Elective Outpatient Surgery under General Anesthesia Surgery Length from 30 to 120 minutes (from induction of anesthesia to extubation) Exclusion Criteria: Patient refusal or inability to consent Neuraxial (spinal or epidural) anesthesia BMI over 40 (Flex gown limitation) Pregnancy Active infection Systemic disease which impairs thermoregulation (hypothyroidism or hyperthyroidism, adrenal insufficiency, major burns, para / quadriplegia) Medications affecting core body temperature (like levothyroxine) Facial surgery Use of a fluid warmer
Facility Information:
Facility Name
CIUSSS de l'Est de l'Ile de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T2M4
Country
Canada

12. IPD Sharing Statement

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Comparison of Active Prewarming Versus Standard Care to Prevent Perioperative Hyporthermia in Short Outpatient Surgery Under General Anesthesia

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