Comparison of Underbody and Overbody Forced Air Blanket in Pediatric Patients Undergoing Cardiovascular Interventions

Hypothermia; Anesthesia Clinical Trial

Official title:

Comparison of Underbody and Overbody Forced Air Blanket for Maintaining Normothermia in Pediatric Patients Undergoing Cardiovascular Interventions Under General Anesthesia: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05349734
• Other study ID #: 2005-016-1121
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2022
• Est. completion date: May 11, 2023

Study information

• Verified date: February 2023
• Source: Seoul National University Hospital
• Contact: Hee-Soo Kim, MD, PhD
• Phone: 02-2072-3659
• Email: dami0605[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 11, 2023
• Est. primary completion date: May 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia; Anesthesia

Intervention

Other:
• overbody blanket
applying overbody blanket with forced-air blower set to 43?
• underbody blanket
applying underbody blanket with forced-air blower set to 43?

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	clinical outcomes after the surgery	postoperative complications during hospitalization	5 days after the surgery