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).

Study Overview

• Status: Completed
• Conditions: Hypothermia
• Intervention / Treatment: Device: Patient Warming with Forced Air; Device: Resistive Warming

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Oliver Kimberger

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Core Temperature at the end of surgery (at time of skin suture)	Single Measurement at Beginning of Skin Suture

Secondary Outcome Measures

Outcome Measure	Time Frame
Core temperature increase (°C/time)	From Beginning until End of Surgery

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: January 25, 2010
• First Submitted That Met QC Criteria: February 24, 2010
• First Posted (Estimate): February 25, 2010

Study Record Updates

• Last Update Posted (Estimate): January 15, 2015
• Last Update Submitted That Met QC Criteria: January 14, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Perioperative Hypothermia Prevention; Accidental Perioperative Hypothermia
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: HDBH3