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NCT02342431 Clinical Trial

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

Hypothermia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02342431
Other study ID # momo_bh_1
Secondary ID
Status Withdrawn
Phase Phase 4
First received November 13, 2012
Last updated January 14, 2015
Start date October 2010
Est. completion date March 2011

Study information
Verified date January 2015
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Year
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- fever or therapeutic hypothermia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Forced air warming compressible
Warming with a compressible forced air mattress
• Forced air non-compressible
Warming with a non-compressible forced air mattress

Locations
Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of hypothermia during surgery (1 - 6 hours) No
Secondary Core Temperature Slope during surgery (1 - 6 hours) No
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