Comparison Study of Intraoperative Patient Warming Systems

Study Overview
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Brief Summary
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Medications used to put people to sleep during surgical procedures also cause changes in the body's ability to control its temperature. These changes can make a person's temperature drop below normal. To minimize this drop in body temperature, different types of body warming products are used during surgery. This study is designed to compare the the temperatures of people under general anesthesia after 60 minutes of warming with each product. The study hypothesis is that the people warmed with the Dynatherm Medical vitalHEAT vH2 System will decrease less in the first 60 minutes of warming time than people warmed with the Arizant Bair Hugger System.

Official Title
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Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHEAT Temperature Management System(vH2)With the Arizant Bair Hugger System

Conditions
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Orthopedic Surgery, General Anesthesia

Intervention / Treatment
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* Device: vitalHEAT vH2 Temperature Management System
* Device: Arizant Healthcare Bair Hugger Temperature Management System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pts undergoing orthopedic surgical procedure with expected duration 2-3 hrs General anesthesia required ASA physical status I-III Exclusion Criteria: General anesthesia plus epidural anesthesia required Skin abrasions/trauma to extremity selected as application site History of peripheral vascular disease History of malignant hyperthermia Unwilling/unable to give consent

Ages Eligible for Study
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Minimum Age: 18 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: 1<br>Use of the Dynatherm Medical vitalHEAT vH2 Temperature Management System to warm patients undergoing orthopedic surgical procedures with an expected duration 2-3 hours and requiring general anesthesia. | Device: vitalHEAT vH2 Temperature Management System<br>* The vH2 system utilizes a combination of localized heat and vacuum application to one hand & forearm; this application opens AVAs in the palm of the hand and warms the extremity thus effectively warming the blood flowing to the body's core.<br>|
| Active Comparator: 2<br>Use of the Arizant Healthcare Bair Hugger Temperature Management System & Bair Hugger Upper Body Blanket to warm patients undergoing orthopedic surgical procedures with an expected duration 2-3 hours and requiring general anesthesia. | Device: Arizant Healthcare Bair Hugger Temperature Management System<br>* The Bair Hugger system is a forced air system providing convective warming via the circulation of warmed air through specially designed blanket which is placed over a portion of the body<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare esophageal temperatures after 60 minutes of warming with each system |  | 60 minutes of patient warming | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare esophageal temperature trends during surgical procedures |  | Every 15 minutes during procedure | 
| Compare sublingual temperatures of patients in PACU |  | Within 10 minutes of arrival in PACU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient warming