Comparison of Upper Body and Full Underbody Forced Air Blanket in Pediatric Patients
1 other identifier
interventional
92
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2022
CompletedFirst Posted
Study publicly available on registry
April 27, 2022
CompletedStudy Start
First participant enrolled
May 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2023
CompletedApril 24, 2025
April 1, 2025
10 months
April 9, 2022
April 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
hypothermia
time weighted average out of normothernia (body temperature over 37.5℃ and under 36.5℃) in intraoperative period
intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)
Secondary Outcomes (5)
hyperthermia
intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)
thermal comfort scale
15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit
patient satifisfaction at post-anesthesia care unit
15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit
shivering score at post-anesthesia care unit
15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit
clinical outcomes after the surgery
5 days after the surgery
Study Arms (2)
upper body
EXPERIMENTALfull underbody
ACTIVE COMPARATORInterventions
applying full underbody blanket with forced-air blower set to 43℃
Eligibility Criteria
You may qualify if:
- pediatric patients under 15 years of age who are scheduled for cardiovascular interventions in angioroom
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 40399788DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 9, 2022
First Posted
April 27, 2022
Study Start
May 12, 2022
Primary Completion
March 2, 2023
Study Completion
March 3, 2023
Last Updated
April 24, 2025
Record last verified: 2025-04