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

Primary Purpose

Hypothermia; Anesthesia

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
overbody blanket
underbody blanket
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypothermia; Anesthesia

Eligibility Criteria

1 Day - 15 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

overbody blanket

underbody blanket

Arm Description

Outcomes

Primary Outcome Measures

hypothermia
time weighted average out of normothernia (body temperature over 37.5℃ and under 36.5℃) in intraoperative period

Secondary Outcome Measures

hyperthermia
body temperature recorded over 37.5℃
thermal comfort scale
asking subjects about the thermal sensation on a seven-point scale from cold(-3) to hot (+3)
patient satifisfaction at post-anesthesia care unit
visual analog scale score for measuring the patient satisfaction after the surgery (0~10)
shivering score at post-anesthesia care unit
4 grades of shivering score measured at post-anesthesia care unit
clinical outcomes after the surgery
postoperative complications during hospitalization

Full Information

First Posted
April 9, 2022
Last Updated
February 8, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05349734
Brief Title
Comparison of Underbody and Overbody Forced Air Blanket in Pediatric Patients Undergoing Cardiovascular Interventions
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
May 11, 2023 (Anticipated)
Study Completion Date
May 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia; Anesthesia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
overbody blanket
Arm Type
Experimental
Arm Title
underbody blanket
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
overbody blanket
Intervention Description
applying overbody blanket with forced-air blower set to 43℃
Intervention Type
Other
Intervention Name(s)
underbody blanket
Intervention Description
applying underbody blanket with forced-air blower set to 43℃
Primary Outcome Measure Information:
Title
hypothermia
Description
time weighted average out of normothernia (body temperature over 37.5℃ and under 36.5℃) in intraoperative period
Time Frame
intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)
Secondary Outcome Measure Information:
Title
hyperthermia
Description
body temperature recorded over 37.5℃
Time Frame
intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)
Title
thermal comfort scale
Description
asking subjects about the thermal sensation on a seven-point scale from cold(-3) to hot (+3)
Time Frame
15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit
Title
patient satifisfaction at post-anesthesia care unit
Description
visual analog scale score for measuring the patient satisfaction after the surgery (0~10)
Time Frame
15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit
Title
shivering score at post-anesthesia care unit
Description
4 grades of shivering score measured at post-anesthesia care unit
Time Frame
15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit
Title
clinical outcomes after the surgery
Description
postoperative complications during hospitalization
Time Frame
5 days after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee-Soo Kim, MD, PhD
Phone
02-2072-3659
Ext
82
Email
dami0605@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heesoo Kim

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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