Comparison of a Patient Warming System Using a Forced-air, Non-compressible Under-body Mattress Versus a Regular Forced-air Underbody Mattress System During Pediatric Cardiac Catheterization

Phase 4

Withdrawn

• Conditions: Hypothermia
• Interventions: Device: Forced air warming compressible; Device: Forced air non-compressible

• Registration Number: NCT02342431
• Lead Sponsor: Medical University of Vienna

Brief Summary

The study is a comparison of a patient warming system using a forced-air, non-compressible under-body mattress (Möck \& Möck, Hamburg, Germany) versus a regular forced-air underbody mattress system during pediatric cardiac catheterization in 40 patients.

The hypothesis is, that the non-compressible mattress provides better warming with less incidence of perioperative hypothermia (Core temperature \< 36 °C) and faster warming slope (°C / time). The study is prospective, randomized, controlled and single-blinded.

Inclusion criteria will be pediatric patients \< 1 year of age without fever or a treatment of therapeutic hypothermia.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2012-11-13
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-14
• Last Update Submitted: 2015-01-14
• Study First Posted: 2015-01-21
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Pediatric patient scheduled for cardiac catheterization (diagnostic and/or interventional)< 1 year old

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Exclusion Criteria

• fever or therapeutic hypothermia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Forced air compressible warming	Forced air warming compressible	Warming with a compressible forced air mattress
Forced air non-compressible	Forced air non-compressible	Warming with a non-compressible forced air mattress

Primary Outcome Measures

Name	Time	Method
Incidence of hypothermia	during surgery (1 - 6 hours)

Secondary Outcome Measures

Name	Time	Method
Core Temperature Slope	during surgery (1 - 6 hours)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria