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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02342431

Enrollment

Registered

2015-01-21

Start date

2010-10-31

Completion date

2011-03-31

Last updated

2015-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia

Keywords

Thermoregulation, Pediatric Anesthesia, Cardiac Catheterization

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.

Interventions

DEVICEForced air warming compressible

Warming with a compressible forced air mattress

DEVICEForced air non-compressible

Warming with a non-compressible forced air mattress

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* fever or therapeutic hypothermia

Design outcomes

Primary

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

Secondary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026