Prospective Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Control Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients

Conditions
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Perioperative Hypothermia

Intervention / Treatment
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* Device: Bair-Paws Warming Device
* Device: Bair-Hugger Warming Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing total hip arthroplasty under neuraxial anesthesia, age 55-85, BMI 18-40 Exclusion Criteria: allergy to local anesthetics, patients electing to have general anesthesia for their total hip arthroplasty, pregnancy, prisoners, patients unable to give informed consent, English as a second language, active infectious or febrile illness (measured temperature > 37.5 degrees Celsius).

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-Warming<br> | Device: Bair-Paws Warming Device<br>* Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.<br>|
| Active Comparator: Control<br> | Device: Bair-Hugger Warming Device<br>* Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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). |