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

January 25, 2010
July 28, 2010
January 2010
July 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01075724 on ClinicalTrials.gov Archive Site
Core temperature increase (°C/time) [ Time Frame: From Beginning until End of Surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of a New Patient Warming System Using a Polymer Conductive Warming Under-body and Upper-body Blanket With Forced Air Warming
Comparison of a New Patient Warming System Using a Polymer Conductive Warming Under-body and Upper-body Blanket With Forced Air Warming During Surgery

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hypothermia
  • Device: Patient Warming with Forced Air
    Forced Air warming via BairHugger
  • Device: Resistive Warming
    Resistive Warming via HotDog device
  • Active Comparator: Forced air
    Forced Air Warming
    Intervention: Device: Patient Warming with Forced Air
  • Experimental: Resistive HotDog Warming
    Warming by resistive Warming
    Intervention: Device: Resistive Warming
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01075724
HDBH3
No
Oliver Kimberger, Medical University of Vienna
Medical University of Vienna
Not Provided
Not Provided
Medical University of Vienna
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP