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Surgeons change in preference for perioperative warming.
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The purpose of this study is to determine if placement of a forced-air warming device prior to institution of regional anesthesia improves perioperative temperature control in patients undergoing total hip arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Warming | Experimental |
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| Control | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bair-Paws Warming Device | Device | Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System.. | Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR. | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System. | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). | |
| Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-Warming | Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming. |
| FG001 | Control | Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Bair-Hugger Warming Device | Device | Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution). |
|
| The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). |
| Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System. | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). |
| Incidence of Postoperative Shivering in Recovery Room. | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). |
| Intraoperative Blood Loss. | Intraoperative blood loss in mL's. | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). |
| Incidence of Perioperative Cardiac Events. | Incidence of perioperative arrhythmias or myocardial ischemia. | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). |
| Temporal Artery Verus SpotOn (3M) Temperature Readings. | Temperature with temporal artery thermometer and SpotOn temperature monitoring device (3M) at time of incision. | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-Warming | Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming. |
| BG001 | Control | Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Temperature | Mean | Standard Deviation | Degrees Celisius |
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| 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 | Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System.. | Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR. | Posted | Mean | Standard Deviation | Degrees Celsius | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). |
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| Secondary | Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System. | Posted | Mean | Standard Deviation | Degrees Celsius | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). |
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| Secondary | Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System. | Posted | Mean | Standard Deviation | Degrees Celsius | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). |
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| Secondary | Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System. | Posted | Mean | Standard Deviation | Degrees Celsius | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). |
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| Secondary | Incidence of Postoperative Shivering in Recovery Room. | Posted | Number | Number of patients reporting shivering | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). |
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| Secondary | Intraoperative Blood Loss. | Intraoperative blood loss in mL's. | Posted | Mean | Standard Deviation | mL | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). |
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| Secondary | Incidence of Perioperative Cardiac Events. | Incidence of perioperative arrhythmias or myocardial ischemia. | Posted | Number | Patients | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). |
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| Secondary | Temporal Artery Verus SpotOn (3M) Temperature Readings. | Temperature with temporal artery thermometer and SpotOn temperature monitoring device (3M) at time of incision. | Posted | Mean | Standard Deviation | Degrees Celsius | The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment). |
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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 | Pre-Warming | Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming. | 0 | 47 | 0 | 47 | ||
| EG001 | Control | Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution). | 0 | 51 | 0 | 51 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kristopher Schroeder, MD | University of Wisconsin School of Medicine and Public Health | 608-263-8100 | kmschro1@wisc.edu |
| >=65 years |
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| Male |
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