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Comparison Study of Intraoperative Patient Warming Systems

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ClinicalTrials.gov Identifier: NCT00670826
Recruitment Status : Unknown
Verified April 2008 by Dynatherm Medical Inc..
Recruitment status was:  Not yet recruiting
First Posted : May 2, 2008
Last Update Posted : May 2, 2008
Sponsor:
Information provided by:
Dynatherm Medical Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Orthopedic Surgery General Anesthesia Device: vitalHEAT vH2 Temperature Management System Device: Arizant Healthcare Bair Hugger Temperature Management System Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHEAT Temperature Management System(vH2)With the Arizant Bair Hugger System
Study Start Date : July 2008
Estimated Primary Completion Date : September 2008
Estimated Study Completion Date : November 2008

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



Primary Outcome Measures :
  1. Compare esophageal temperatures after 60 minutes of warming with each system [ Time Frame: 60 minutes of patient warming ]

Secondary Outcome Measures :
  1. Compare esophageal temperature trends during surgical procedures [ Time Frame: Every 15 minutes during procedure ]
  2. Compare sublingual temperatures of patients in PACU [ Time Frame: Within 10 minutes of arrival in PACU ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Sponsors and Collaborators
Dynatherm Medical Inc.
Investigators
Principal Investigator: Kent P Weinmeister, MD Mayo Clinic

Responsible Party: Kent Weinmeister, MD, Mayo Clinic Scottsdale
ClinicalTrials.gov Identifier: NCT00670826     History of Changes
Other Study ID Numbers: M100 IRB07-003313
TP0010C
First Posted: May 2, 2008    Key Record Dates
Last Update Posted: May 2, 2008
Last Verified: April 2008

Keywords provided by Dynatherm Medical Inc.:
Patient warming