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| Name | Class |
|---|---|
| Dynatherm Medical Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VH2 | Experimental | Dynatherm vitalHeat2 (VH2) temperature management system. |
|
| Bair Hugger | Active Comparator | Arizant Bair Hugger temperature management system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VH2 | Device | Dynatherm vitalHeat2 (VH2) temperature management system. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sublingual Temperature. | Within 10 minutes of arrival in PACU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kent Weinmeister, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19779953 | Derived | 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. |
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75 consented. 9 cancelled surgery or were rescheduled. 36 assigned to VH2 and 30 assigned to Bair Hugger. 6 excluded from VH2 group after randomization (2 vacuum not established, 2 research staff not available, 2 arterial line used). 5 excluded from Bair Hugger group after randomization (4 laryngeal mask airway used, 1 epidural anesthesia used).
Patients were recruited sequentially and assigned to vitalHeat2 (VH2) or Bair Hugger temperature management at random in a 1:1 ratio.
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| ID | Title | Description |
|---|---|---|
| FG000 | VH2 Temperature Management | Dynatherm vitalHeat2 (VH2) temperature management system. |
| FG001 | Bair Hugger Temperature Management | Arizant Bair Hugger temperature management system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VH2 Temperature Management | Dynatherm vitalHeat2 (VH2) temperature management system. |
| BG001 | Bair Hugger Temperature Management | Arizant Bair Hugger temperature management system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sublingual Temperature. | Per protocol. | Posted | Mean | Standard Deviation | C | Within 10 minutes of arrival in PACU |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VH2 Temperature Management | Dynatherm vitalHeat2 (VH2) temperature management system. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terrence L Trentman MD | Mayo Clinic | 480-301-8000 | trentman.terrence@mayo.edu |
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| Bair Hugger |
| Device |
Arizant Bair Hugger temperature management system. |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Bair Hugger Temperature Management | Arizant Bair Hugger temperature management system. | 0 | 25 | 0 | 25 |
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