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

NCT ID: NCT02342431

Last Updated: 2015-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Forced air compressible warming

Warming with a compressible forced air mattress

Group Type ACTIVE_COMPARATOR

Forced air warming compressible

Intervention Type DEVICE

Warming with a compressible forced air mattress

Forced air non-compressible

Warming with a non-compressible forced air mattress

Group Type EXPERIMENTAL

Forced air non-compressible

Intervention Type DEVICE

Warming with a non-compressible forced air mattress

Interventions

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Forced air warming compressible

Warming with a compressible forced air mattress

Intervention Type DEVICE

Forced air non-compressible

Warming with a non-compressible forced air mattress

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* fever or therapeutic hypothermia
Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Oliver Kimberger

Assoc.Prof PD Dr. MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oliver Kimberger, PD, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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momo_bh_1

Identifier Type: -

Identifier Source: org_study_id

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