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Hypothermia Following AnesthesiaPREWARMINGNCT04601636

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

A study testing Active Prewarming in people with Hypothermia Following Anesthesia and Hypothermia, Accidental, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Active Prewarming
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteCanada
Study dates
26 Oct 2020to 31 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 9Show fewer
  • Medications affecting core body temperature (like levothyroxine)
  • Facial surgery
  • Use of a fluid warmer

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • CIUSSS de l'Est de l'Ile de Montreal

    Montreal, Quebec, H1T2M4

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Active Prewarming, Standard Care
Keywords
Outpatient Surgeries, Short Surgeries, Active Prewarming
Medical subject headings
Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active PrewarmingDevice

    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 CareOther

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

Study groups in NCT04601636
Study groupRoleWhat they receive
Active Prewarming group (PW group)Active comparatorGroup randomized to receive at least 30 minutes of active prewarming before induction of anesthesia, combined to active warming intraoperatively.
Receives: Device: Active Prewarming
Control group (C group)Placebo comparatorGroup randomized to receive the standard care : passive prewarming before induction of anesthesia combined to active warming intraoperatively.
Receives: Other: Standard Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Temperature at the end of surgery (°Celsius)

    Patient Temperature at the end of surgery

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

Secondary outcomes (6)
  1. Incidence of Hypothermia (presence or absence)

    Incidence of hypothermia, defined as a core body temperature below 36°Celsius

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

  2. Delta Temperature Loss (°Celsius)

    Maximum Temperature Loss intraoperatively (from the temperature at entry in the operating room to the minimum temperature reached during surgery )

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

  3. Shivering incidence (number of episodes)

    Number of shivering episodes at the recovery room

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

  4. 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)

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

  5. Recovery Room Length of Stay (minutes)

    Length of Stay in the Recovery Room

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

  6. 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)

    Measured: Right before entry in the operating room

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2020
  2. Study start26 Oct 2020
  3. Primary completion31 Jan 2021
  4. Study completion31 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04601636
Sponsor's protocol ID
2021-2427
Acronym
PREWARMING
Status last verified
Oct 2021
First submitted
20 Oct 2020
Last updated
4 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Active Prewarming in people with Hypothermia Following Anesthesia and Hypothermia, Accidental, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.

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