Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes

Study Overview
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Brief Summary
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The application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers. The warmers are commonly used with both the supplied blankets and also with hospital blankets. Subjects receiving standard care will not benefit from this study. Subjects in the investigational group may benefit in several ways: Increased comfort in the pre-operative period by being warmer Decreased incidence of mild hypothermia Possible decreased incidence of transfusion with less bleeding Possible decreased pain and discomfort in the Post-Anesthesia Care Unit (PACU) Possible shorter stay in the PACU and overall Length of Stay (LOS) Possible decreased risk for surgical site infection

Official Title
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Randomized, Prospective Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Perioperative Surgical Outcomes

Conditions
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Hypothermia

Intervention / Treatment
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* Device: Bair Paws Patient Adjustable Warming System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective or urgent surgery under general anesthesia ≥19 years but ≤85 years of age Able to provide informed consent. Exclusion Criteria: Refusal of Informed consent Metabolic derangement/drug therapy already affecting thermal homeostasis Preexisting hypothermia (<35.5 degreeC) or hyperthermia (>37.5 degreeC) (oral) Surgical procedure anticipated to be longer than 6 hours or less than 1 hour Emergency (category 1a) Surgery Patients undergoing exclusively spinal or epidural anesthesia Patients receiving aortic cross-clamping Patients receiving transdermal medications

Ages Eligible for Study
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Minimum Age: 19 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bair PawsPatient Adjustable Warming System<br>Bair PawsPatient Adjustable Warming System for active pre-warming | Device: Bair Paws Patient Adjustable Warming System<br>* Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.<br>* Other names: Bair Paws Flex Gown;|
| Other: Passive pre-warming<br>Passive pre-warming | Device: Bair Paws Patient Adjustable Warming System<br>* Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.<br>* Other names: Bair Paws Flex Gown;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hypothermia | The primary endpoint is duration of hypothermia as measured by the area under the curve (AUC). This is achieved by recording patient temperature readings continuously from baseline (prior to initiation of 30 minutes if active or passive pre-warming) until PACU discharge. | Up to 12 hours, until PACU discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypothermia, surgical site infection, opioid usage, blood loss, pain severity, anxiety, Length of Stay