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

NCT04601636 | Completed

• 1 other identifier: 2021-2427
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia Following Anesthesia; Hypothermia, Accidental

Keywords

Outpatient Surgeries; Short Surgeries; Active Prewarming

Outcome Measures

Primary Outcomes (1)

• Temperature at the end of surgery (°Celsius)

  Patient Temperature at the end of surgery

  Measure taken at the end of surgery, before the patient leaves the operating room for the recovery room (below 120 minutes)

Secondary Outcomes (6)

• Incidence of Hypothermia (presence or absence)

  Intraoperative (time frame when patient is in the operative room - below 120 minutes)

• Delta Temperature Loss (°Celsius)

  Intraoperative (time frame when patient is in the operative room - below 120 minutes)

• Shivering incidence (number of episodes)

  Length of Stay in the Recovery Room (maximum 2h)

• Grade of Shivering (likert scale 0 to 4)

  Length of Stay in the Recovery Room (maximum 2h)

• Recovery Room Length of Stay (minutes)

  Length of Stay in the Recovery Room (maximum 2h)

Study Arms (2)

Active Prewarming group (PW group)

ACTIVE COMPARATOR

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

Device: Active Prewarming

Control group (C group)

PLACEBO COMPARATOR

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

Other: Standard Care

Interventions

Active Prewarming DEVICE

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)

Active Prewarming group (PW group)

Standard Care OTHER

Standard care with a passive prewarming (warm cotton blankets) before induction of anesthesia, with active warming intraoperatively with (Bair Hugger, 3M)

Control group (C group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

CIUSSS de l'Est de l'Ile de Montreal

Montreal, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Hypothermia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD, DESAR, Chair of Research

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: October 26, 2020
• Primary Completion: January 31, 2021
• Study Completion: May 31, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-10

Locations

CA (1)