General Anesthesia, Orthopedic Surgery
Conditions
Keywords
Patient warming
Brief summary
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.
Interventions
DEVICEvitalHEAT vH2 Temperature Management System
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.
DEVICEArizant Healthcare Bair Hugger Temperature Management System
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
Sponsors
Dynatherm Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare esophageal temperatures after 60 minutes of warming with each system | 60 minutes of patient warming |
Secondary
| Measure | 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 |
Countries
United States
Contacts
Primary ContactKent P Weinmeister, MD
Outcome results
None listed