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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypothermia; Anesthesia

Intervention / Treatment
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* Other: overbody blanket
* Other: underbody blanket


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: overbody blanket<br> | Other: overbody blanket<br>* applying overbody blanket with forced-air blower set to 43℃<br>|
| Active Comparator: underbody blanket<br> | Other: underbody blanket<br>* applying underbody blanket with forced-air blower set to 43℃<br>|

What is the study measuring?
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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 |