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

• ClinicalTrials.gov Identifier: NCT01075724
• Recruitment Status: Completed
• First Posted: February 25, 2010
• Last Update Posted: January 15, 2015
• Sponsor: Medical University of Vienna
• Information provided by (Responsible Party): Oliver Kimberger, Medical University of Vienna

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Hypothermia	Device: Patient Warming with Forced Air; Device: Resistive Warming	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• 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
• Study Start Date: January 2010
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: July 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Core Temperature at the end of surgery (at time of skin suture) [ Time Frame: Single Measurement at Beginning of Skin Suture ]

Secondary Outcome Measures :

1. Core temperature increase (°C/time) [ Time Frame: From Beginning until End of Surgery ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: HDBH3
• 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