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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:
ClinicalTrials.gov Identifier:
NCT01075724
First Posted: February 25, 2010
Last Update Posted: January 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oliver Kimberger, Medical University of Vienna
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Oliver Kimberger, 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 ]

Secondary Outcome Measures:
  • Core temperature increase (°C/time) [ Time Frame: From Beginning until End of Surgery ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075724


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

Responsible Party: Oliver Kimberger, Assoc.Prof.PD Dr. MSc, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01075724     History of Changes
Other Study ID Numbers: HDBH3
First Submitted: January 25, 2010
First Posted: February 25, 2010
Last Update Posted: January 15, 2015
Last Verified: January 2015

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

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