NCT02342431

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2012

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

5 months

First QC Date

November 13, 2012

Last Update Submit

January 14, 2015

Conditions

Hypothermia

Keywords

ThermoregulationPediatric AnesthesiaCardiac Catheterization

Outcome Measures

Primary Outcomes (1)

  • Incidence of hypothermia

    during surgery (1 - 6 hours)

Secondary Outcomes (1)

  • Core Temperature Slope

    during surgery (1 - 6 hours)

Study Arms (2)

Forced air compressible warming

ACTIVE COMPARATOR

Warming with a compressible forced air mattress

Device: Forced air warming compressible

Forced air non-compressible

EXPERIMENTAL

Warming with a non-compressible forced air mattress

Device: Forced air non-compressible

Interventions

Forced air warming compressibleDEVICE

Warming with a compressible forced air mattress

Forced air compressible warming
Forced air non-compressibleDEVICE

Warming with a non-compressible forced air mattress

Forced air non-compressible

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • fever or therapeutic hypothermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Oliver Kimberger, PD, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof PD Dr. MSc

Study Record Dates

First Submitted

November 13, 2012

First Posted

January 21, 2015

Study Start

October 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations

AU(1)