Hypothermia, AccidentalNCT03408197
Two Warming Methods in Knee Arthroplasty
A study testing EasyWarm and BairHugger in people with Hypothermia, Accidental, run by Tampere University Hospital at 1 site in Finland.
Trial summary
In this study two warming methods will be compared in knee arthroplasty surgery. Barrier EasyWarm will be used in the study group and BairHugger upper body warming blanket in the control group. Both groups will be prewarmed 30 minutes before spinal anaesthesia. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Hypothermia, Accidental
- What is being tested?
- EasyWarm and BairHugger
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFinland
- Study dates
- 19 Nov 2018to 31 May 2020
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI 25-40
- ASA class I-III
- elective primary unilateral kneearthroplasty
- spinal anaesthesia
Who cannot join
- ASA class > III
- unstable coronary artery disease
- revision surgery, bilateral arthroplasty
- general anaesthesia
- decreased mental status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Warming Methods in Knee Arthroplasty. A Prospective, Randomized Non-inferiority Trial.
In this study two warming methods will be compared in knee arthroplasty surgery. Barrier EasyWarm will be used in the study group and BairHugger upper body warming blanket in the control group. Both groups will be prewarmed 30 minutes before spinal anaesthesia. In the operating room warming will be continued with the same warming method. Primary end point is core temperature after arriving to post anaesthesia care unit. Hypothesis is that Barrier EasyWarm is not inferior to BairHugger in preventing inadvertent intraoperative hypothermia.
Few methods exist to measure the core temperature non-invasively. Zero-heat-flux technique is used in this study. During the study we will test the accuracy of the 3M BairHugger Temperature Monitoring System by placing two sensors onto the patients (n = 30) fore head. After that the accuracy of the Dräger Tcore is examined by comparing it with the 3M BairHugger Temperature Monitoring System. So the patients (n=30) have both these different core temperature monitoring systems on their foreheads. This observational monitoring study is performed from the patient number 80 until the end.
- Conditions
- Hypothermia, Accidental
- Being tested
- EasyWarm, BairHugger
- Keywords
- inadvertent, intraoperative hypothermia, prewarming, core temperature monitoring
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EasyWarmDevice
Perioperative warming with EasyWarm to prevent inadvertent hypothermia during anaesthesia
BairHuggerDevice
Perioperative warming with BairHugger to prevent inadvertent hypothermia during anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| EasyWarm | Experimental | Not described Receives: Device: EasyWarm |
| BairHugger | Active comparator | Not described Receives: Device: BairHugger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core temperature after arriving to the post-anaesthesia care unit
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start19 Nov 2018
- Primary completion11 Nov 2019
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypothermia, AccidentalStudies 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
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maija-Liisa Kalliomäki, Study director, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408197
- Sponsor's protocol ID
- R17136
- Status last verified
- Jan 2021
- First submitted
- 17 Jan 2018
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lauronen SL, Kalliovalkama J, Aho A, Makinen MT, Huhtala H, Yli-Hankala AM, Kalliomaki ML. Self-warming blanket versus forced-air warming blanket during total knee arthroplasty under spinal anaesthesia: A randomised non-inferiority trial. Acta Anaesthesiol Scand. 2023 Sep;67(8):1102-1109. doi: 10.1111/aas.14283. Epub 2023 May 28.
PubMed 37246242Lauronen SL, Kalliomaki ML, Kalliovalkama J, Aho A, Huhtala H, Yli-Hankala AM, Makinen MT. Comparison of zero heat flux and double sensor thermometers during spinal anaesthesia: a prospective observational study. J Clin Monit Comput. 2022 Oct;36(5):1547-1555. doi: 10.1007/s10877-021-00799-6. Epub 2022 Jan 3.
PubMed 34978656
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Warming Methods in Knee Arthroplasty. A Prospective, Randomized Non-inferiority Trial.
- ClinicalTrials.gov ID
- NCT03408197
- Acronym / sponsor ID
- R17136
- Conditions
- Hypothermia, Accidental
- Keywords
- inadvertent, intraoperative hypothermia, prewarming, core temperature monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 23 Jan 2018 (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.
In this study two warming methods will be compared in knee arthroplasty surgery. Barrier EasyWarm will be used in the study group and BairHugger upper body warming blanket in the control group. Both groups will be prewarmed 30 minutes before spinal anaesthesia. In the operating room warming will be continued with the same warming method. Primary end point is core temperature after arriving to post anaesthesia care unit. Hypothesis is that Barrier EasyWarm is not inferior to BairHugger in preventing inadvertent intraoperative hypothermia.
Few methods exist to measure the core temperature non-invasively. Zero-heat-flux technique is used in this study. During the study we will test the accuracy of the 3M BairHugger Temperature Monitoring System by placing two sensors onto the patients (n = 30) fore head. After that the accuracy of the Dräger Tcore is examined by comparing it with the 3M BairHugger Temperature Monitoring System. So the patients (n=30) have both these different core temperature monitoring systems on their foreheads. This observational monitoring study is performed from the patient number 80 until the end.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EasyWarm | Experimental | Device: EasyWarm |
| BairHugger | Active comparator | Device: BairHugger |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI 25-40
- ASA class I-III
- elective primary unilateral kneearthroplasty
- spinal anaesthesia
Key exclusion criteria (5 listed)
- ASA class > III
- unstable coronary artery disease
- revision surgery, bilateral arthroplasty
- general anaesthesia
- decreased mental status
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 |
|---|---|---|
| EasyWarmPerioperative warming with EasyWarm to prevent inadvertent hypothermia during anaesthesia | Device | EasyWarm |
| BairHuggerPerioperative warming with BairHugger to prevent inadvertent hypothermia during anaesthesia | Device | BairHugger |
Primary outcome
Core temperature after arriving to the post-anaesthesia care unit
Time frame: one hour
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 22 Jan 2021.
- Derived from this study: PubMed 37246242Lauronen SL, Kalliovalkama J, Aho A, Makinen MT, Huhtala H, Yli-Hankala AM, Kalliomaki ML. Self-warming blanket versus forced-air warming blanket during total knee arthroplasty under spinal anaesthesia: A randomised non-inferiority trial. Acta Anaesthesiol Scand. 2023 Sep;67(8):1102-1109. doi: 10.1111/aas.14283. Epub 2023 May 28.
- Derived from this study: PubMed 34978656Lauronen SL, Kalliomaki ML, Kalliovalkama J, Aho A, Huhtala H, Yli-Hankala AM, Makinen MT. Comparison of zero heat flux and double sensor thermometers during spinal anaesthesia: a prospective observational study. J Clin Monit Comput. 2022 Oct;36(5):1547-1555. doi: 10.1007/s10877-021-00799-6. Epub 2022 Jan 3.
- Individual participant dataSharing planned: No
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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.
Maija-Liisa Kalliomäki study director
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EasyWarm and BairHugger in people with Hypothermia, Accidental, run by Tampere University Hospital at 1 site in Finland.
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 4 inclusion and 5 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 22 Jan 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 Finland. 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?
Core temperature after arriving to the post-anaesthesia care unit (time frame: one hour). 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 NCT03408197, which also lists 2 linked publications.
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 22 Jan 2021; AzTrials last refreshed its copy on 29 Oct 2026.