Total Knee ArthroplastyPhase 3NCT00711867
Comparison of Intraoperative Warming Devices
A Phase 3 study testing VH2 and Bair Hugger in people with Total Knee Arthroplasty, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- VH2 and Bair Hugger
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHeat™ Temperature Management System (vH2) and the Arizant Bair Hugger System
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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- VH2, Bair Hugger
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VH2Device
Dynatherm vitalHeat2 (VH2) temperature management system.
Bair HuggerDevice
Arizant Bair Hugger temperature management system.
| Study group | Role | What they receive |
|---|---|---|
| VH2 | Experimental | Dynatherm vitalHeat2 (VH2) temperature management system. Receives: Device: VH2 |
| Bair Hugger | Active comparator | Arizant Bair Hugger temperature management system. Receives: Device: Bair Hugger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sublingual Temperature.
Measured: Within 10 minutes of arrival in PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Dynatherm Medical Inc.
- Investigators
- Kent Weinmeister, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711867
- Sponsor's protocol ID
- 07-003313
- Status last verified
- Dec 2009
- First submitted
- 7 Jul 2008
- Last updated
- 15 Dec 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 19779953
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHeat™ Temperature Management System (vH2) and the Arizant Bair Hugger System
- ClinicalTrials.gov ID
- NCT00711867
- Acronym / sponsor ID
- 07-003313
- Conditions
- Total Knee Arthroplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Dynatherm Medical Inc.
- Study start
- Jul 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Posted 2 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VH2 | Experimental | Device: VH2Dynatherm vitalHeat2 (VH2) temperature management system. |
| Bair Hugger | Active comparator | Device: Bair HuggerArizant Bair Hugger temperature management system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VH2Dynatherm vitalHeat2 (VH2) temperature management system. | Device | VH2 |
| Bair HuggerArizant Bair Hugger temperature management system. | Device | Bair Hugger |
Primary outcome
Sublingual Temperature.
Time frame: Within 10 minutes of arrival in PACU
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19779953Trentman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kent Weinmeister, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VH2 and Bair Hugger in people with Total Knee Arthroplasty, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sublingual Temperature. (time frame: Within 10 minutes of arrival in PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00711867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2009.