Core Body TemperatureNCT02993666
Comparison of Upper and Lower Body Air Warming in Patients Undergoing Thoracic Surgery
A study testing Bair Hugger in people with Core Body Temperature, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is conducted to evaluate the effectiveness of forced air warming using upper and lower body blankets by measuring core body temperature in patients undergoing video-assisted thoracic surgery in the lateral decubitus position over 2 hours of general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Core Body Temperature
- What is being tested?
- Bair Hugger
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to Jun 2017
- 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
- patients undergoing video-assisted thoracic surgery over 2 hours
- ASA I, II and III
- age over 18 years
Who cannot join
- refuse to enroll
- patients with fever or hypothermia before surgery
- patients who required changes of position during surgery
Trial locations and contacts
1 site in 1 country.
About this study
This study is conducted to evaluate the effectiveness of forced air warming using upper and lower body blankets by measuring core body temperature in patients undergoing video-assisted thoracic surgery in the lateral decubitus position over 2 hours of general anesthesia.
- Conditions
- Core Body Temperature
- Being tested
- Bair Hugger
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bair HuggerDevice
forced air warming with Bair Hugger air warmer
| Study group | Role | What they receive |
|---|---|---|
| upper body | Experimental | warming with upper body blankets Receives: Device: Bair Hugger |
| lower body | Experimental | warming with lower body blankets Receives: Device: Bair Hugger |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative incidence of hypothermia
Measured: through surgery completion, up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2017
- Study completionJun 2017
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 Core Body TemperatureStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Hwa Seo, Seoul National University Hospital
- Investigators
- JH Seo, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993666
- Sponsor's protocol ID
- JHSeo_FAW
- Status last verified
- Jun 2017
- First submitted
- 1 Dec 2016
- Last updated
- 12 Jun 2017
- Results posted
- No
Publications
Min SH, Yoon S, Yoon SH, Bahk JH, Seo JH. Randomised trial comparing forced-air warming to the upper or lower body to prevent hypothermia during thoracoscopic surgery in the lateral decubitus position. Br J Anaesth. 2018 Mar;120(3):555-562. doi: 10.1016/j.bja.2017.11.091. Epub 2017 Dec 5.
PubMed 29452812
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Upper and Lower Body Air Warming in Patients Undergoing Thoracic Surgery
- ClinicalTrials.gov ID
- NCT02993666
- Acronym / sponsor ID
- JHSeo_FAW
- Conditions
- Core Body Temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 15 Dec 2016 (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.
This study is conducted to evaluate the effectiveness of forced air warming using upper and lower body blankets by measuring core body temperature in patients undergoing video-assisted thoracic surgery in the lateral decubitus position over 2 hours of general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| upper body | Experimental | Device: Bair Huggerwarming with upper body blankets |
| lower body | Experimental | Device: Bair Huggerwarming with lower body blankets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing video-assisted thoracic surgery over 2 hours
- ASA I, II and III
- age over 18 years
Key exclusion criteria (3 listed)
- refuse to enroll
- patients with fever or hypothermia before surgery
- patients who required changes of position during 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 Huggerforced air warming with Bair Hugger air warmer | Device | lower body, upper body |
Primary outcome
intraoperative incidence of hypothermia
Time frame: through surgery completion, up to 4 hours
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 12 Jun 2017.
- Derived from this study: PubMed 29452812Min SH, Yoon S, Yoon SH, Bahk JH, Seo JH. Randomised trial comparing forced-air warming to the upper or lower body to prevent hypothermia during thoracoscopic surgery in the lateral decubitus position. Br J Anaesth. 2018 Mar;120(3):555-562. doi: 10.1016/j.bja.2017.11.091. Epub 2017 Dec 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.
JH Seo principal investigator
Seoul National 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 Bair Hugger in people with Core Body Temperature, run by Seoul National University Hospital at 1 site in South Korea.
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 3 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 12 Jun 2017. 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 South Korea. 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?
intraoperative incidence of hypothermia (time frame: through surgery completion, up to 4 hours). 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 NCT02993666, 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 12 Jun 2017.