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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

NCT02342431 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-01-21

No results posted yet for this study

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.

Conditions

  • Hypothermia

Interventions

DEVICE

Forced air warming compressible

Warming with a compressible forced air mattress

DEVICE

Forced air non-compressible

Warming with a non-compressible forced air mattress

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Oliver Kimberger, PD, MD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02342431 on ClinicalTrials.gov