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Completed

NCT Number: NCT05349734

Comparison of Upper Body and Full Underbody Forced Air Blanket in Pediatric Patients

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.

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Key information

Conditions

Hypothermia; Anesthesia Body Temperature Changes Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 day–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

upper body blanket

Other

applying upper body blanket with forced-air blower set to 43℃

full underbody blanket

Other

applying full underbody blanket with forced-air blower set to 43℃

Primary outcomes

  1. hypothermia

    Time frame: intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)

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

Secondary outcomes

  1. hyperthermia

    Time frame: intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)

    body temperature recorded over 37.5℃

  2. thermal comfort scale

    Time frame: 15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit

    asking subjects about the thermal sensation on a seven-point scale from cold(-3) to hot (+3)

  3. patient satifisfaction at post-anesthesia care unit

    Time frame: 15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit

    visual analog scale score for measuring the patient satisfaction after the surgery (0~10)

  4. shivering score at post-anesthesia care unit

    Time frame: 15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit

    4 grades of shivering score measured at post-anesthesia care unit

  5. clinical outcomes after the surgery

    Time frame: 5 days after the surgery

    postoperative complications during hospitalization

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2022
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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