Comparison Study of Intraoperative Patient Warming Systems

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Dynatherm Medical Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Dynatherm Medical Inc.
ClinicalTrials.gov Identifier:
NCT00670826
First received: April 29, 2008
Last updated: May 1, 2008
Last verified: April 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Sponsors and Collaborators
Dynatherm Medical Inc.
Investigators
Principal Investigator: Kent P Weinmeister, MD Mayo Clinic
  More Information

No publications provided

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

Keywords provided by Dynatherm Medical Inc.:
Patient warming

ClinicalTrials.gov processed this record on July 20, 2014