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

Tracking Information

• First Submitted Date: January 25, 2010
• First Posted Date: February 25, 2010
• Last Update Posted Date: January 15, 2015
• Study Start Date: January 2010
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 24, 2010): Core Temperature at the end of surgery (at time of skin suture) [ Time Frame: Single Measurement at Beginning of Skin Suture ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: February 24, 2010): Core temperature increase (°C/time) [ Time Frame: From Beginning until End of Surgery ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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).

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Hypothermia

Intervention

• Device: Patient Warming with Forced Air
  Forced Air warming via BairHugger
• Device: Resistive Warming
  Resistive Warming via HotDog device

Study Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 24, 2010): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2010
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT01075724
• Other Study ID Numbers: HDBH3
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Oliver Kimberger, Medical University of Vienna
• Study Sponsor: Medical University of Vienna
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Medical University of Vienna
• Verification Date: January 2015