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

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 Overview

• Status: Completed
• Conditions: Hypothermia; Anesthesia
• Intervention / Treatment: Other: upper body blanket; Other: full underbody blanket

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 15 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: upper body	Other: upper body blanket; applying upper body blanket with forced-air blower set to 43℃
Active Comparator: full underbody	Other: full underbody blanket; applying full underbody blanket with forced-air blower set to 43℃

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
hyperthermia	body temperature recorded over 37.5℃	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)	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)	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	15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit
clinical outcomes after the surgery	postoperative complications during hospitalization	5 days after the surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): March 2, 2023
• Study Completion (Actual): March 3, 2023

Study Registration Dates

• First Submitted: April 9, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: 2005-016-1121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No