Comparison of a New Patient Warming System Using a Polymer Conductive Warming Under-body and Upper-body Blanket With Forced Air Warming

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01075724
First received: January 25, 2010
Last updated: July 28, 2010
Last verified: July 2010
  Purpose

Intraoperative active warming is usually performed by skin warming. There are several forced-air systems on the market; forced air warming is generally described as the most effective yet feasible method of patient warming.

Augustine Biomedical (Eden Prairie, MN, USA) recently introduced a new patient warming system named "Hot Dog" with an active polymer warming upper-body blanket and a new under-body warming mattress. The polymer-heating devices consist of an electronic regulator and the polymer blankets, which are covered with a washable fabric. Conventional mains power the system. The manufacturer claims, that the new system "Hot Dog" (with combination of under body and upper body warming) is as effective as forced air warming, while not having any disadvantages of the forced air system, like: airborne infection, noise, high power consumption and hard-to-clean hose.

The investigators will compare the new Hot Dog patient warming device combination (under body + upper body) with the established warming system, which blows warm air via a mattress over the body of the patients).


Condition Intervention Phase
Hypothermia
Device: Patient Warming with Forced Air
Device: Resistive Warming
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of a New Patient Warming System Using a Polymer Conductive Warming Under-body and Upper-body Blanket With Forced Air Warming During Surgery

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Core Temperature at the end of surgery (at time of skin suture) [ Time Frame: Single Measurement at Beginning of Skin Suture ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Core temperature increase (°C/time) [ Time Frame: From Beginning until End of Surgery ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Forced air
Forced Air Warming
Device: Patient Warming with Forced Air
Forced Air warming via BairHugger
Experimental: Resistive HotDog Warming
Warming by resistive Warming
Device: Resistive Warming
Resistive Warming via HotDog device

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The investigators will study 40 patients (18-90 years) undergoing elective orthopedic lower limb surgery at the trauma surgery unit. The patients must have normal weight (20-30 BMI), the duration of surgery should last between 2 - 3 hours.

Exclusion Criteria:

  • There will be no other exclusion criteria (except severe peripheral arterial disease in the warmed extremity), as forced air patient warming is routinely used for all patients during this procedure.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01075724

Locations
Austria
Oliver Kimberger
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Oliver Kimberger, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01075724     History of Changes
Other Study ID Numbers: HDBH3
Study First Received: January 25, 2010
Last Updated: July 28, 2010
Health Authority: Austria: Federal Insitute for Medicinal Products

Keywords provided by Medical University of Vienna:
Perioperative Hypothermia Prevention
Accidental Perioperative Hypothermia

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014