WithdrawnNCT02342431Updated Jan 21, 2015

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

A Phase 4 interventional study of Forced air warming compressible and Forced air non-compressible in Hypothermia, sponsored by Medical University of Vienna. Withdrawn at 1 site in Austria. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2015-01-21.

Sponsored by Medical University of Vienna · Phase 4, Interventional, and Treatment

Why this study was withdrawn

Cardiac Catheterization no longer part of the anesthesia department A (no belonging to cardiac anesthesia, which is a different department)

Phase: Phase 4
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: Up to 1 Year
Sex: All

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 studied

Hypothermia

Browse trials for

Hypothermia 499

Keywords

Thermoregulation
Pediatric Anesthesia
Cardiac Catheterization

In context

Hypothermia

499 studies on the registry are indexed under Hypothermia; 54 are open to participants now.

Browse Hypothermia studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 1 Year
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

fever or therapeutic hypothermia

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 0 participants (actual)

Study arms

Active comparator
Forced air compressible warming
Warming with a compressible forced air mattress
Device: Forced air warming compressible
Experimental
Forced air non-compressible
Warming with a non-compressible forced air mattress
Device: Forced air non-compressible

Interventions

DeviceForced air warming compressible
Warming with a compressible forced air mattress
DeviceForced air non-compressible
Warming with a non-compressible forced air mattress

What researchers measure

Primary outcomes

Incidence of hypothermia
Time frame: during surgery (1 - 6 hours)

Secondary outcomes

Core Temperature Slope
Time frame: during surgery (1 - 6 hours)

Study locations

1 site

Medical University of Vienna
Vienna, 1090, Austria

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02342431
Lead sponsor: Medical University of Vienna
Responsible party: Oliver Kimberger (Assoc.Prof PD Dr. MSc, Medical University of Vienna) — Principal investigator
First posted: Jan 21, 2015
Start date: Oct 2010
Primary completion: Mar 2011 (estimated)
Completion: Mar 2011 (estimated)
Last update: Jan 21, 2015

Study contacts

Oliver Kimberger, PD, MD

principal investigator · Medical University of Vienna

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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