Comparison of a New Patient Warming System Using Polymer Conductive Warming With Forced Air Warming During Surgery
HDV
1 other identifier
interventional
80
1 country
1
Brief Summary
Two patient warming systems will be compared with 40 patients each in a convective warming group (BairHugger, Arizant) and in a conductive warming group (HotDog, Augustine Biomedical). The patients will undergo small to medium trauma surgery and will be warmed with the randomized device - the hypothesis is, that the area under the standardized core temperature / time curve is significantly greater in the conductive warming group. Secondary outcome is the mean skin temperature / time area under the curve.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2008
Shorter than P25 for phase_3
1 active site
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, 2008
CompletedFirst Submitted
Initial submission to the registry
October 14, 2008
CompletedFirst Posted
Study publicly available on registry
October 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedSeptember 21, 2009
September 1, 2009
8 months
October 14, 2008
September 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area under the standardized "core temperature * time" curve
intraoperatively
Secondary Outcomes (1)
Area under "mean skin temperature * time" curve
intraoperatively
Study Arms (2)
Forced Air
ACTIVE COMPARATORWarming with forced air (BairHugger)
Conductive Warming
EXPERIMENTALWarming with the conductive device (HotDog)
Interventions
Warming device set to maximum (43 °C)
Eligibility Criteria
You may qualify if:
- The patients must have normal weight (20-30 BMI), the duration of surgery should last between 3 - 4 hours.
You may not qualify if:
- Severe peripheral artery disease in the warmed extremity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, Vienna, 1090, Austria
Related Publications (1)
Brandt S, Oguz R, Huttner H, Waglechner G, Chiari A, Greif R, Kurz A, Kimberger O. Resistive-polymer versus forced-air warming: comparable efficacy in orthopedic patients. Anesth Analg. 2010 Mar 1;110(3):834-8. doi: 10.1213/ANE.0b013e3181cb3f5f. Epub 2009 Dec 30.
PMID: 20042442DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Kimberger, M.D.
Medical University of Vienna
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 14, 2008
First Posted
October 15, 2008
Study Start
October 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
September 21, 2009
Record last verified: 2009-09