Comparison Study of Intraoperative Patient Warming Systems

May 1, 2008 updated by: Dynatherm Medical Inc.

Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHEAT Temperature Management System(vH2)With the Arizant Bair Hugger System

Medications used to put people to sleep during surgical procedures also cause changes in the body's ability to control its temperature. These changes can make a person's temperature drop below normal. To minimize this drop in body temperature, different types of body warming products are used during surgery. This study is designed to compare the the temperatures of people under general anesthesia after 60 minutes of warming with each product. The study hypothesis is that the people warmed with the Dynatherm Medical vitalHEAT vH2 System will decrease less in the first 60 minutes of warming time than people warmed with the Arizant Bair Hugger System.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pts undergoing orthopedic surgical procedure with expected duration 2-3 hrs
  • General anesthesia required
  • ASA physical status I-III

Exclusion Criteria:

  • General anesthesia plus epidural anesthesia required
  • Skin abrasions/trauma to extremity selected as application site
  • History of peripheral vascular disease
  • History of malignant hyperthermia
  • Unwilling/unable to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Use of the Dynatherm Medical vitalHEAT vH2 Temperature Management System to warm patients undergoing orthopedic surgical procedures with an expected duration 2-3 hours and requiring general anesthesia.
Device: vitalHEAT vH2 Temperature Management System
The vH2 system utilizes a combination of localized heat and vacuum application to one hand & forearm; this application opens AVAs in the palm of the hand and warms the extremity thus effectively warming the blood flowing to the body's core.
Active Comparator: 2
Use of the Arizant Healthcare Bair Hugger Temperature Management System & Bair Hugger Upper Body Blanket to warm patients undergoing orthopedic surgical procedures with an expected duration 2-3 hours and requiring general anesthesia.
Device: Arizant Healthcare Bair Hugger Temperature Management System
The Bair Hugger system is a forced air system providing convective warming via the circulation of warmed air through specially designed blanket which is placed over a portion of the body

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare esophageal temperatures after 60 minutes of warming with each system
Time Frame: 60 minutes of patient warming
60 minutes of patient warming

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare esophageal temperature trends during surgical procedures
Time Frame: Every 15 minutes during procedure
Every 15 minutes during procedure
Compare sublingual temperatures of patients in PACU
Time Frame: Within 10 minutes of arrival in PACU
Within 10 minutes of arrival in PACU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dynatherm Medical Inc.

Investigators

  • Principal Investigator: Kent P Weinmeister, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

September 1, 2008

Study Completion (Anticipated)

November 1, 2008

Study Registration Dates

First Submitted

April 29, 2008

First Submitted That Met QC Criteria

May 1, 2008

First Posted (Estimate)

May 2, 2008

Study Record Updates

Last Update Posted (Estimate)

May 2, 2008

Last Update Submitted That Met QC Criteria

May 1, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M100 IRB07-003313
  • TP0010C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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