Comparison of Intraoperative Warming Devices

Total Knee Arthroplasty Clinical Trial

Official title:

Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHeat™ Temperature Management System (vH2) and the Arizant Bair Hugger System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711867
• Other study ID #: 07-003313
• Status: Completed
• Phase: Phase 3
• First received: July 7, 2008
• Last updated: December 9, 2009
• Start date: July 2008
• Est. completion date: December 2008

Study information

• Verified date: December 2009
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The sublingual (under the tongue) core temperature within 10 minutes of arrival in the post anesthesia care unit (PACU) for patients warmed with the Dynatherm vitalHeat2 (VH2) System under general anesthesia for total knee arthroplasty will be equivalent to that of patients warmed with the Arizant Bair Hugger System.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Initial total knee arthroplasty.

• Expected duration of surgery at least 2 hours.

• General anesthesia.

• American Society of Anesthesiologists (ASA) classification I-III.

• Age >= 18 years.

Exclusion Criteria:

• Skin abrasion at the device application site.

• History of peripheral vascular disease.

• History of allergic skin conditions of the upper extremities.

• History of malignant hyperthermia.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Device:
• VH2
Dynatherm vitalHeat2 (VH2) temperature management system.
• Bair Hugger
Arizant Bair Hugger temperature management system.

Locations

Country	Name	City	State
United States	Mayo Clinic	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Dynatherm Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sublingual Temperature.		Within 10 minutes of arrival in PACU	No