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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

Primary Purpose

Hypothermia

Status

Withdrawn

Phase

Phase 4

Locations

Austria

Study Type

Interventional

Intervention

Forced air warming compressible

Forced air non-compressible

About this trial

This is an interventional treatment trial for Hypothermia focused on measuring Thermoregulation, Pediatric Anesthesia, Cardiac Catheterization

Eligibility Criteria

undefined - 1 Year (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

fever or therapeutic hypothermia

Sites / Locations

Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Forced air compressible warming

Forced air non-compressible

Arm Description

Warming with a compressible forced air mattress

Warming with a non-compressible forced air mattress

Outcomes

Primary Outcome Measures

Incidence of hypothermia

Secondary Outcome Measures

Core Temperature Slope

Full Information

NCT ID

NCT02342431

First Posted

November 13, 2012

Last Updated

January 14, 2015

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT02342431

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Withdrawn

Why Stopped

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

Study Start Date

October 2010 (undefined)

Primary Completion Date

March 2011 (Anticipated)

Study Completion Date

March 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypothermia

Keywords

Thermoregulation, Pediatric Anesthesia, Cardiac Catheterization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Forced air compressible warming

Arm Type

Active Comparator

Arm Description

Warming with a compressible forced air mattress

Arm Title

Forced air non-compressible

Arm Type

Experimental

Arm Description

Warming with a non-compressible forced air mattress

Intervention Type

Device

Intervention Name(s)

Forced air warming compressible

Intervention Description

Warming with a compressible forced air mattress

Intervention Type

Device

Intervention Name(s)

Forced air non-compressible

Intervention Description

Warming with a non-compressible forced air mattress

Primary Outcome Measure Information:

Title

Incidence of hypothermia

Time Frame

during surgery (1 - 6 hours)

Secondary Outcome Measure Information:

Title

Core Temperature Slope

Time Frame

during surgery (1 - 6 hours)

10. Eligibility

Sex

All

Maximum Age & Unit of Time

1 Year

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pediatric patient scheduled for cardiac catheterization (diagnostic and/or interventional)< 1 year old Exclusion Criteria: fever or therapeutic hypothermia

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oliver Kimberger, PD, MD

Organizational Affiliation

Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

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

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