At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 55 enrolled
Drug / intervention
VH2 +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHeat™ Temperature Management System (vH2) and the Arizant Bair Hugger System
In Brief
A Phase 3 clinical trial evaluating VH2 and Bair Hugger for Total Knee Arthroplasty. Completed, enrolled 55 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTotal Knee Arthroplasty
CountriesUnited States
CollaboratorsDynatherm Medical Inc.
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedJul 2008
Primary CompletionDec 2008
TodayJul 2026
First PostedJul 9, 2008
Enrollment StartJul 1, 2008
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 18.0 years ago
Interventions
VH2device
Dynatherm vitalHeat2 (VH2) temperature management system.
Bair Huggerdevice
Arizant Bair Hugger temperature management system.