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

Not Applicable

Completed

• Conditions: Hypothermia; Anesthesia
• Interventions: Other: overbody blanket; Other: underbody blanket

• Registration Number: NCT05349734
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-09
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-27
• Study Start: 2022-05-12
• Primary Completion: 2023-03-02
• Study Completion: 2023-03-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
overbody blanket	overbody blanket	-
underbody blanket	underbody blanket	-

Primary Outcome Measures

Name	Time	Method
hypothermia	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

Secondary Outcome Measures

Name	Time	Method
hyperthermia	intraoperative 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℃
shivering score at post-anesthesia care unit	15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit	4 grades of shivering score measured at post-anesthesia care unit
thermal comfort scale	15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit	asking subjects about the thermal sensation on a seven-point scale from cold(-3) to hot (+3)
clinical outcomes after the surgery	5 days after the surgery	postoperative complications during hospitalization
patient satifisfaction at post-anesthesia care unit	15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit	visual analog scale score for measuring the patient satisfaction after the surgery (0\~10)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of