A Phase 4 interventional study of Bair-Paws Warming Device and Bair-Hugger Warming Device in Perioperative Hypothermia, sponsored by University of Wisconsin, Madison. Terminated at 1 site in United States. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-08-15.
Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Treatment
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.
499 studies on the registry are indexed under Hypothermia; 53 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 350 interventional studies indexed under Hypothermia.
Browse Hypothermia studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Bair-Paws Warming Device
Device: Bair-Hugger Warming Device
Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
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.
Time frame: 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 Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
| Milestone | Pre-Warming | Control |
|---|---|---|
| Started | 49 | 51 |
| Completed | 47 | 51 |
| Not completed | 2 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR.
| Degrees Celsius | Pre-Warming | Control |
|---|---|---|
| Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System.. | 35.7 ± 0.47 | 35.4 ± 0.49 |
| Degrees Celsius | Pre-Warming | Control |
|---|---|---|
| Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System. | 36.7 ± 0.4 | 36.6 ± 0.4 |
| Degrees Celsius | Pre-Warming | Control |
|---|---|---|
| Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System. | 35.7 ± 0.4 | 35.4 ± 0.4 |
| Degrees Celsius | Pre-Warming | Control |
|---|---|---|
| Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System. | 35.4 ± 0.8 | 35.1 ± 0.6 |
| Number of patients reporting shivering | Pre-Warming | Control |
|---|---|---|
| Incidence of Postoperative Shivering in Recovery Room. | 1 | 14 |
Intraoperative blood loss in mL's.
| mL | Pre-Warming | Control |
|---|---|---|
| Intraoperative Blood Loss. | 263 ± 109 | 307 ± 116 |
Incidence of perioperative arrhythmias or myocardial ischemia.
| Patients | Pre-Warming | Control |
|---|---|---|
| Incidence of Perioperative Cardiac Events. | 1 | 0 |
Temperature with temporal artery thermometer and SpotOn temperature monitoring device (3M) at time of incision.
| Degrees Celsius | Temporal Artery Thermometer | SpotOn (3M) Temperature Readings. |
|---|---|---|
| Temporal Artery Verus SpotOn (3M) Temperature Readings. | 36.5 ± 0.5 | 36.5 ± 0.5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre-Warming | — | 0/47 (0%) | 0/47 (0%) |
| Control | — | 0/51 (0%) | 0/51 (0%) |
| Age, Categorical(Participants) | Pre-Warming | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 23 | 44 |
| >=65 years | 26 | 28 | 54 |
| Age, Continuous(years) | Pre-Warming | Control | Total |
|---|---|---|---|
| Mean | 66.1 ± 6.37 | 66.5 ± 7.41 | 66.3 ± 6.9 |
| Sex: Female, Male(Participants) | Pre-Warming | Control | Total |
|---|---|---|---|
| Female | 27 | 24 | 51 |
| Male | 20 | 27 | 47 |
| Region of Enrollment(participants) | Pre-Warming | Control | Total |
|---|---|---|---|
| United States | 47 | 51 | 98 |
| Baseline Temperature(Degrees Celisius) | Pre-Warming | Control | Total |
|---|---|---|---|
| Mean | 36.6 ± 0.4 | 36.7 ± 0.37 | 36.6 ± 0.39 |
This study is terminated, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison