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Completed

NCT Number: NCT04601636

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CIUSSS de l'Est de l'Ile de Montreal

Montreal, Quebec, H1T2M4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Standard care

Other

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Ciusss de L'Est de l'Île de Montréal

Other

Registry information

Official study 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

Acronym: PREWARMING

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 26, 2020
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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