Comparison of Intraoperative Warming Devices
Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHeat™ Temperature Management System (vH2) and the Arizant Bair Hugger System
1 other identifier
interventional
55
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 7, 2008
CompletedFirst Posted
Study publicly available on registry
July 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
December 2, 2009
CompletedDecember 15, 2009
December 1, 2009
5 months
July 7, 2008
October 28, 2009
December 9, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Sublingual Temperature.
Within 10 minutes of arrival in PACU
Study Arms (2)
VH2
EXPERIMENTALDynatherm vitalHeat2 (VH2) temperature management system.
Bair Hugger
ACTIVE COMPARATORArizant Bair Hugger temperature management system.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Dynatherm Medical Inc.collaborator
Study Sites (1)
Mayo Clinic
Phoenix, Arizona, 85054, United States
Related Publications (1)
Trentman TL, Weinmeister KP, Hentz JG, Laney MB, Simula DV. Randomized non-inferiority trial of the vitalHEAT temperature management system vs the Bair Hugger warmer during total knee arthroplasty. Can J Anaesth. 2009 Dec;56(12):914-20. doi: 10.1007/s12630-009-9199-2. Epub 2009 Sep 25.
PMID: 19779953DERIVED
Results Point of Contact
- Title
- Terrence L Trentman MD
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Kent Weinmeister, M.D.
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 7, 2008
First Posted
July 9, 2008
Study Start
July 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
December 15, 2009
Results First Posted
December 2, 2009
Record last verified: 2009-12