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

• ClinicalTrials.gov Identifier: NCT04601636
• Recruitment Status: Completed
• First Posted: October 26, 2020
• Last Update Posted: October 4, 2021
• Sponsor: Ciusss de L'Est de l'Île de Montréal
• Information provided by (Responsible Party): Philippe Richebe, Ciusss de L'Est de l'Île de Montréal

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.

Condition or disease	Intervention/treatment	Phase
Hypothermia Following Anesthesia; Hypothermia, Accidental	Device: Active Prewarming; Other: Standard Care	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: October 26, 2020
• Actual Primary Completion Date: January 31, 2021
• Actual Study Completion Date: May 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Active Prewarming group (PW group); Group randomized to receive at least 30 minutes of active prewarming before induction of anesthesia, combined to active warming intraoperatively.	Device: Active Prewarming; 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)
Placebo Comparator: Control group (C group); Group randomized to receive the standard care : passive prewarming before induction of anesthesia combined to active warming intraoperatively.	Other: Standard Care; Standard care with a passive prewarming (warm cotton blankets) before induction of anesthesia, with active warming intraoperatively with (Bair Hugger, 3M)

Outcome Measures

Primary Outcome Measures :

1. Temperature at the end of surgery (°Celsius) [ Time Frame: Measure taken at the end of surgery, before the patient leaves the operating room for the recovery room (below 120 minutes) ]
   Patient Temperature at the end of surgery

Secondary Outcome Measures :

1. Incidence of Hypothermia (presence or absence) [ Time Frame: Intraoperative (time frame when patient is in the operative room - below 120 minutes) ]
   Incidence of hypothermia, defined as a core body temperature below 36°Celsius
2. Delta Temperature Loss (°Celsius) [ Time Frame: Intraoperative (time frame when patient is in the operative room - below 120 minutes) ]
   Maximum Temperature Loss intraoperatively (from the temperature at entry in the operating room to the minimum temperature reached during surgery )
3. Shivering incidence (number of episodes) [ Time Frame: Length of Stay in the Recovery Room (maximum 2h) ]
   Number of shivering episodes at the recovery room
4. Grade of Shivering (likert scale 0 to 4) [ Time Frame: Length of Stay in the Recovery Room (maximum 2h) ]
   Grade of Shivering according to Crossley and Mahajan grading scale of intraoperative shivering (from 0 to 4)
5. Recovery Room Length of Stay (minutes) [ Time Frame: Length of Stay in the Recovery Room (maximum 2h) ]
   Length of Stay in the Recovery Room
6. Patient Comfort Level (likert scale 0 to 10) [ Time Frame: Right before entry in the operating room ]
   Evaluation of the Patient's Thermal Comfort Level according to a verbal numerical rating scale (from 0 - extremely uncomfortable ; to 10 - extremely comfortable)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, Quebec

CIUSSS de l'Est de l'Ile de Montreal

Montreal, Quebec, Canada, H1T2M4

Sponsors and Collaborators

Ciusss de L'Est de l'Île de Montréal

More Information

• Responsible Party: Philippe Richebe, Professor, MD, PhD, DESAR, Chair of Research, Ciusss de L'Est de l'Île de Montréal
• ClinicalTrials.gov Identifier: NCT04601636
• Other Study ID Numbers: 2021-2427
• First Posted: October 26, 2020
• Last Update Posted: October 4, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Philippe Richebe, Ciusss de L'Est de l'Île de Montréal:

Outpatient Surgeries; Short Surgeries; Active Prewarming

Additional relevant MeSH terms:

Hypothermia; Body Temperature Changes