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 (Responsible Party):

Oliver Kimberger, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT01075724

First received: January 25, 2010

Last updated: January 14, 2015

Last verified: January 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

January 25, 2010

Last Updated Date

January 14, 2015

Start Date ^ICMJE

January 2010

Primary Completion Date

July 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01075724 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment

Condition ^ICMJE

Hypothermia

Intervention ^ICMJE

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

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2010

Primary Completion Date

July 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Austria

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01075724

Other Study ID Numbers ^ICMJE

HDBH3

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Oliver Kimberger, Medical University of Vienna

Study Sponsor ^ICMJE

Medical University of Vienna

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Medical University of Vienna

Verification Date

January 2015

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

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