Comparison Study of Intraoperative Patient Warming Systems

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00670826
• Other study ID #: M100 IRB07-003313
• Secondary ID: TP0010C
• Status: Not yet recruiting
• Phase: N/A
• First received: April 29, 2008
• Last updated: May 1, 2008
• Start date: July 2008
• Est. completion date: November 2008

Study information

• Verified date: April 2008
• Source: Dynatherm Medical Inc.
• Contact: Kent P Weinmeister, MD
• Phone: 480-342-2446
• Email: weinmeister.kent[@]mayo.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• General Anesthesia
• Orthopedic Surgery

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Dynatherm Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare esophageal temperatures after 60 minutes of warming with each system		60 minutes of patient warming	No
Secondary	Compare esophageal temperature trends during surgical procedures		Every 15 minutes during procedure	No
Secondary	Compare sublingual temperatures of patients in PACU		Within 10 minutes of arrival in PACU	No