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Comparison of forced air and conductive warming devices in outpatient orthopaedic surgeries.
Patients will be randomized into either the Forced Air group (FA) or Conductive Heat group (CH). Randomization will be based on computer-generated codes that will be maintained in sequentially numbered opaque envelopes. Fifty patients will be recruited with 25 patients being randomized into each group.
In patients assigned to the FA group, a Bair Hugger (Arizant Medical, Inc., Eden Prairie, Minnesota) forced-air cover will be positioned over the upper body (if lower extremity surgery) or lower body (if upper extremity surgery). The forced-air blower will be set and activated per standard practice usually after prepping and draping.
In patients assigned to the CH group, a VitaHeat (VitaHeat, Inc, Aurora, IL) conductive heating device will be placed under the torso of the patient. The device will be set and activated per standard practice usually just after positioning of the patient on the operating table.
Patients in both groups will be otherwise draped per surgical routine. Ambient temperature will be maintained near 20°C. Temperatures will be recorded using a temporal artery thermometer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Forced Air | Active Comparator | Bair Hugger |
|
| Conductive Warming | Active Comparator | VitaHeat |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bair Hugger | Device |
| ||
| VitaHeat |
| Measure | Description | Time Frame |
|---|---|---|
| Temperature | Measured by temporal artery thermometer | Intra-Operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Valley Orthopedics | Geneva | Illinois | 60134 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Forced Air | Bair Hugger Bair Hugger |
| FG001 | Conductive Warming | VitaHeat VitaHeat |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Forced Air | Bair Hugger Bair Hugger |
| BG001 | Conductive Warming | VitaHeat VitaHeat |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Temperature | Measured by temporal artery thermometer | Posted | Mean | Standard Deviation | degrees celsius | Intra-Operative |
|
|
1 year
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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 | Forced Air | Bair Hugger Bair Hugger | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vishal Mehta | Fox Valley Orthopaedic Institute | 6305841400 | vmehta@fvortho.com |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Conductive Warming | VitaHeat VitaHeat | 0 | 27 | 0 | 27 | 0 | 27 |
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