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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05349734
Other study ID # 2005-016-1121
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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