Hypothermia; AnesthesiaNCT05349734
Comparison of Upper Body and Full Underbody Forced Air Blanket in Pediatric Patients
A study testing upper body blanket and full underbody blanket in people with Hypothermia; Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to compare the underbody blanket and overbody blanket for forced air warming to maintain normothermia in pediatric patients undergoing cardiovascular interventions under general anesthesia. Read more about this study
- Who is it for?
- Ages 1 day to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothermia; Anesthesia
- What is being tested?
- upper body blanket and full underbody blanket
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 May 2022to 3 Mar 2023
- 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 1 day to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- pediatric patients under 15 years of age who are scheduled for cardiovascular interventions in angioroom
Who cannot join
- anticipated operating time < 1 hour
- body surface area that exposured by drape < 30% of total body surface area
- BMI > 30
- corrected age < 40 weeks
- preoperative body temperature is higher than 37℃ or less than 35.5℃
- patients with skin disease
- history of malignant hyperthermia
- patients who cannot use esophageal stethoscope
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Upper Body and Full Underbody Forced Air Blanket for Maintaining Normothermia in Pediatric Patients Undergoing Cardiovascular Interventions Under General Anesthesia: a Randomized Controlled Trial
The aim of this study is to compare the underbody blanket and overbody blanket for forced air warming to maintain normothermia in pediatric patients undergoing cardiovascular interventions under general anesthesia.
- Conditions
- Hypothermia; Anesthesia
- Being tested
- upper body blanket, full underbody blanket
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper body blanketOther
applying upper body blanket with forced-air blower set to 43℃
full underbody blanketOther
applying full underbody blanket with forced-air blower set to 43℃
| Study group | Role | What they receive |
|---|---|---|
| upper body | Experimental | Not described Receives: Other: upper body blanket |
| full underbody | Active comparator | Not described Receives: Other: full underbody blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypothermia
time weighted average out of normothernia (body temperature over 37.5℃ and under 36.5℃) in intraoperative period
Measured: intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)
Secondary outcomes (5)
hyperthermia
body temperature recorded over 37.5℃
Measured: intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)
thermal comfort scale
asking subjects about the thermal sensation on a seven-point scale from cold(-3) to hot (+3)
Measured: 15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit
patient satifisfaction at post-anesthesia care unit
visual analog scale score for measuring the patient satisfaction after the surgery (0~10)
Measured: 15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit
shivering score at post-anesthesia care unit
4 grades of shivering score measured at post-anesthesia care unit
Measured: 15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit
clinical outcomes after the surgery
postoperative complications during hospitalization
Measured: 5 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start12 May 2022
- Primary completion2 Mar 2023
- Study completion3 Mar 2023
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 Hypothermia; AnesthesiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349734
- Sponsor's protocol ID
- 2005-016-1121
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2022
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Park JB, Kim TW, Ji SH, Jang YE, Lee JH, Kim JT, Kim HS, Kim EH. Comparison between upper body and full underbody forced-air warming blanket in pediatric patients undergoing cardiovascular interventions under general anesthesia: a randomized controlled trial. BMC Anesthesiol. 2025 May 21;25(1):254. doi: 10.1186/s12871-025-03100-3.
PubMed 40399788
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Upper Body and Full Underbody Forced Air Blanket for Maintaining Normothermia in Pediatric Patients Undergoing Cardiovascular Interventions Under General Anesthesia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05349734
- Acronym / sponsor ID
- 2005-016-1121
- Conditions
- Hypothermia; Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 27 Apr 2022 (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 aim of this study is to compare the underbody blanket and overbody blanket for forced air warming to maintain normothermia in pediatric patients undergoing cardiovascular interventions under general anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| upper body | Experimental | Other: upper body blanket |
| full underbody | Active comparator | Other: full underbody blanket |
Who may qualify
- Ages
- 1 day to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pediatric patients under 15 years of age who are scheduled for cardiovascular interventions in angioroom
Key exclusion criteria (8 listed)
- anticipated operating time < 1 hour
- body surface area that exposured by drape < 30% of total body surface area
- BMI > 30
- corrected age < 40 weeks
- preoperative body temperature is higher than 37℃ or less than 35.5℃
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 |
|---|---|---|
| upper body blanketapplying upper body blanket with forced-air blower set to 43℃ | Other | upper body |
| full underbody blanketapplying full underbody blanket with forced-air blower set to 43℃ | Other | full underbody |
Primary outcome
hypothermia
Time frame: intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)
time weighted average out of normothernia (body temperature over 37.5℃ and under 36.5℃) in intraoperative period
5 secondary outcomes
hyperthermia
Time frame: intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)
thermal comfort scale
Time frame: 15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit
patient satifisfaction at post-anesthesia care unit
Time frame: 15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit
shivering score at post-anesthesia care unit
Time frame: 15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit
clinical outcomes after the surgery
Time frame: 5 days after the surgery
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 24 Apr 2025.
- Derived from this study: PubMed 40399788Park JB, Kim TW, Ji SH, Jang YE, Lee JH, Kim JT, Kim HS, Kim EH. Comparison between upper body and full underbody forced-air warming blanket in pediatric patients undergoing cardiovascular interventions under general anesthesia: a randomized controlled trial. BMC Anesthesiol. 2025 May 21;25(1):254. doi: 10.1186/s12871-025-03100-3.
- Individual participant dataSharing planned: Undecided
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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 upper body blanket and full underbody blanket in people with Hypothermia; Anesthesia, 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 1 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 24 Apr 2025. 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?
hypothermia (time frame: intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)). 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 NCT05349734, 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 24 Apr 2025.