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Comparison of Upper Body and Full Underbody Forced Air Blanket in Pediatric Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05349734
Enrollment
92
Registered
2022-04-27
Start date
2022-05-12
Completion date
2023-03-03
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia; Anesthesia

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.

Interventions

OTHERupper body blanket

applying upper body blanket with forced-air blower set to 43℃

OTHERfull underbody blanket

applying full underbody blanket with forced-air blower set to 43℃

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Days to 15 Years
Healthy volunteers
Yes

Inclusion criteria

* pediatric patients under 15 years of age who are scheduled for cardiovascular interventions in angioroom

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
hypothermiaintraoperative 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

Secondary

MeasureTime frameDescription
hyperthermiaintraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)body temperature recorded over 37.5℃
thermal comfort scale15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unitasking subjects about the thermal sensation on a seven-point scale from cold(-3) to hot (+3)
patient satifisfaction at post-anesthesia care unit15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unitvisual analog scale score for measuring the patient satisfaction after the surgery (0\ 10)
shivering score at post-anesthesia care unit15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit4 grades of shivering score measured at post-anesthesia care unit
clinical outcomes after the surgery5 days after the surgerypostoperative complications during hospitalization

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026