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

Medical University of Vienna

Status and phase: Withdrawn; Phase 4

Conditions: Hypothermia

Treatments: Device: Forced air non-compressible; Device: Forced air warming compressible

Study type: Interventional

Funder types: Other

Identifiers

NCT02342431

momo_bh_1

Details and patient eligibility

About

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.

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• fever or therapeutic hypothermia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Forced air compressible warming

Active Comparator group

Description:

Warming with a compressible forced air mattress

Treatment:

Device: Forced air warming compressible

Forced air non-compressible

Experimental group

Description:

Warming with a non-compressible forced air mattress

Treatment:

Device: Forced air non-compressible