HypothermiaNCT02177903
Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes
A study testing Bair Paws Patient Adjustable Warming System in people with Hypothermia, run by Solventum US LLC at 1 site in Canada.
Trial summary
The application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers. The warmers are commonly used with both the supplied blankets and also with hospital blankets. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Hypothermia
- What is being tested?
- Bair Paws Patient Adjustable Warming System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Dec 2015
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective or "urgent" surgery under general anesthesia
- ≥19 years but ≤85 years of age
- Able to provide informed consent.
Who cannot join
- Refusal of Informed consent
- Metabolic derangement/drug therapy already affecting thermal homeostasis
- Preexisting hypothermia (<35.5 degreeC) or hyperthermia (>37.5 degreeC) (oral)
- Surgical procedure anticipated to be longer than 6 hours or less than 1 hour
- Emergency (category 1a) Surgery
- Patients undergoing exclusively spinal or epidural anesthesia
- Patients receiving aortic cross-clamping
- Patients receiving transdermal medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Prospective Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Perioperative Surgical Outcomes
The application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers. The warmers are commonly used with both the supplied blankets and also with hospital blankets.
Subjects receiving standard care will not benefit from this study. Subjects in the investigational group may benefit in several ways:
- Increased comfort in the pre-operative period by being warmer
- Decreased incidence of mild hypothermia
- Possible decreased incidence of transfusion with less bleeding
- Possible decreased pain and discomfort in the Post-Anesthesia Care Unit (PACU)
- Possible shorter stay in the PACU and overall Length of Stay (LOS)
- Possible decreased risk for surgical site infection
- Conditions
- Hypothermia
- Being tested
- Bair Paws Patient Adjustable Warming System
- Keywords
- hypothermia, surgical site infection, opioid usage, blood loss, pain severity, anxiety, Length of Stay
- Medical subject headings
- Hypothermia, Surgical Wound Infection, Hemorrhage, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bair Paws Patient Adjustable Warming SystemDevice
Also called Bair Paws Flex Gown
Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.
| Study group | Role | What they receive |
|---|---|---|
| Bair PawsPatient Adjustable Warming System | Other | Bair PawsPatient Adjustable Warming System for active pre-warming Receives: Device: Bair Paws Patient Adjustable Warming System |
| Passive pre-warming | Other | Passive pre-warming Receives: Device: Bair Paws Patient Adjustable Warming System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hypothermia
The primary endpoint is duration of hypothermia as measured by the area under the curve (AUC). This is achieved by recording patient temperature readings continuously from baseline (prior to initiation of 30 minutes if active or passive pre-warming) until PACU discharge.
Measured: Up to 12 hours, until PACU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Richard Merchant, MD, Principal investigator, Staff Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177903
- Sponsor's protocol ID
- EM-05-013093
- Status last verified
- Sep 2024
- First submitted
- 25 Jun 2014
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lau A, Lowlaavar N, Cooke EM, West N, German A, Morse DJ, Gorges M, Merchant RN. Effect of preoperative warming on intraoperative hypothermia: a randomized-controlled trial. Can J Anaesth. 2018 Sep;65(9):1029-1040. doi: 10.1007/s12630-018-1161-8. Epub 2018 Jun 5.
PubMed 29872966
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Perioperative Surgical Outcomes
- ClinicalTrials.gov ID
- NCT02177903
- Acronym / sponsor ID
- EM-05-013093
- Conditions
- Hypothermia
- Keywords
- hypothermia, surgical site infection, opioid usage, blood loss, pain severity, anxiety, Length of Stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Jun 2014 (estimated)
- 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 application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers. The warmers are commonly used with both the supplied blankets and also with hospital blankets.
Subjects receiving standard care will not benefit from this study. Subjects in the investigational group may benefit in several ways:
- Increased comfort in the pre-operative period by being warmer
- Decreased incidence of mild hypothermia
- Possible decreased incidence of transfusion with less bleeding
- Possible decreased pain and discomfort in the Post-Anesthesia Care Unit (PACU)
- Possible shorter stay in the PACU and overall Length of Stay (LOS)
- Possible decreased risk for surgical site infection
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bair PawsPatient Adjustable Warming System | Other | Device: Bair Paws Patient Adjustable Warming SystemBair PawsPatient Adjustable Warming System for active pre-warming |
| Passive pre-warming | Other | Device: Bair Paws Patient Adjustable Warming SystemPassive pre-warming |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective or "urgent" surgery under general anesthesia
- ≥19 years but ≤85 years of age
- Able to provide informed consent.
Key exclusion criteria (8 listed)
- Refusal of Informed consent
- Metabolic derangement/drug therapy already affecting thermal homeostasis
- Preexisting hypothermia (<35.5 degreeC) or hyperthermia (>37.5 degreeC) (oral)
- Surgical procedure anticipated to be longer than 6 hours or less than 1 hour
- Emergency (category 1a) Surgery
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 |
|---|---|---|
| Bair Paws Patient Adjustable Warming SystemAlso: Bair Paws Flex GownBair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming. | Device | Bair PawsPatient Adjustable Warming System, Passive pre-warming |
Primary outcome
Duration of hypothermia
Time frame: Up to 12 hours, until PACU discharge
The primary endpoint is duration of hypothermia as measured by the area under the curve (AUC). This is achieved by recording patient temperature readings continuously from baseline (prior to initiation of 30 minutes if active or passive pre-warming) until PACU discharge.
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 2 Oct 2024.
- Derived from this study: PubMed 29872966Lau A, Lowlaavar N, Cooke EM, West N, German A, Morse DJ, Gorges M, Merchant RN. Effect of preoperative warming on intraoperative hypothermia: a randomized-controlled trial. Can J Anaesth. 2018 Sep;65(9):1029-1040. doi: 10.1007/s12630-018-1161-8. Epub 2018 Jun 5.
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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.
Richard Merchant, MD principal investigator
Staff Anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bair Paws Patient Adjustable Warming System in people with Hypothermia, run by Solventum US LLC 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 8 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 2 Oct 2024. 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. 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?
Duration of hypothermia (time frame: Up to 12 hours, until PACU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02177903, which also lists 1 linked publication.
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 2 Oct 2024.