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.
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
- Conditions the study is for
- Hypothermia Following Anesthesia, Hypothermia, Accidental
- 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)
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- Medications affecting core body temperature (like levothyroxine)
- Facial surgery
- Use of a fluid warmer
Trial locations and contacts
1 site in 1 country.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
Shivering incidence (number of episodes)
Number of shivering episodes at the recovery room
Measured: Length of Stay in the Recovery Room (maximum 2h)
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)
Recovery Room Length of Stay (minutes)
Length of Stay in the Recovery Room
Measured: Length of Stay in the Recovery Room (maximum 2h)
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.
- First posted26 Oct 2020
- Study start26 Oct 2020
- Primary completion31 Jan 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia Following AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Richebe, Ciusss de L'Est de l'Île de Montréal
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04601636
- Acronym / sponsor ID
- PREWARMING / 2021-2427
- Keywords
- Outpatient Surgeries, Short Surgeries, Active Prewarming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Prewarming group (PW group) | Active comparator | Device: Active PrewarmingGroup randomized to receive at least 30 minutes of active prewarming before induction of anesthesia, combined to active warming intraoperatively. |
| Control group (C group) | Placebo comparator | Other: Standard CareGroup randomized to receive the standard care : passive prewarming before induction of anesthesia combined to active warming intraoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- Patient refusal or inability to consent
- Neuraxial (spinal or epidural) anesthesia
- BMI over 40 (Flex gown limitation)
- Pregnancy
- Active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active PrewarmingActive 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) | Device | Active Prewarming group (PW group) |
| Standard CareStandard care with a passive prewarming (warm cotton blankets) before induction of anesthesia, with active warming intraoperatively with (Bair Hugger, 3M) | Other | Control group (C group) |
Primary outcome
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
6 secondary outcomes
Incidence of Hypothermia (presence or absence)
Time frame: Intraoperative (time frame when patient is in the operative room - below 120 minutes)
Delta Temperature Loss (°Celsius)
Time frame: Intraoperative (time frame when patient is in the operative room - below 120 minutes)
Shivering incidence (number of episodes)
Time frame: Length of Stay in the Recovery Room (maximum 2h)
Grade of Shivering (likert scale 0 to 4)
Time frame: Length of Stay in the Recovery Room (maximum 2h)
Recovery Room Length of Stay (minutes)
Time frame: Length of Stay in the Recovery Room (maximum 2h)
Patient Comfort Level (likert scale 0 to 10)
Time frame: Right before entry in the operating room
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.