Comparison Study of Intraoperative Patient Warming Systems - Full Text View

Purpose

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.

Condition	Intervention
Orthopedic Surgery General Anesthesia	Device: vitalHEAT vH2 Temperature Management System Device: Arizant Healthcare Bair Hugger Temperature Management System

MedlinePlus related topics:

Anesthesia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment

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

Further study details as provided by Dynatherm Medical Inc.:

Primary Outcome Measures:

Compare esophageal temperatures after 60 minutes of warming with each system [ Time Frame: 60 minutes of patient warming ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare esophageal temperature trends during surgical procedures [ Time Frame: Every 15 minutes during procedure ] [ Designated as safety issue: No ]
Compare sublingual temperatures of patients in PACU [ Time Frame: Within 10 minutes of arrival in PACU ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	July 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670826

Contacts


Contact: Kent P Weinmeister, MD	480-342-2446	weinmeister.kent@mayo.edu

Locations


United States, Arizona
	Mayo Clinic Hospital
	Phoenix, Arizona, United States, 85054
	Contact: Mary B Laney, CRNA 480-515-6296 ext 73209 laney.mary@mayo.edu

Sponsors and Collaborators

Dynatherm Medical Inc.

Investigators


Principal Investigator:	Kent P Weinmeister, MD	Mayo Clinic Scottsdale

More Information

Responsible Party:	Mayo Clinic Scottsdale ( Kent Weinmeister, MD )
Study ID Numbers:	M100 IRB07-003313, TP0010C
First Received:	April 29, 2008
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00670826
Health Authority:	United States: Institutional Review Board

Keywords provided by Dynatherm Medical Inc.:

Patient warming

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Dynatherm Medical Inc.
Information provided by:	Dynatherm Medical Inc.
ClinicalTrials.gov Identifier:	NCT00670826