Comparison Study of Intraoperative Patient Warming Systems

Dynatherm Medical

Status: Unknown

Conditions: Orthopedic Surgery; General Anesthesia

Treatments: Device: vitalHEAT vH2 Temperature Management System; Device: Arizant Healthcare Bair Hugger Temperature Management System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00670826

M100 IRB07-003313

TP0010C

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Device: vitalHEAT vH2 Temperature Management System

2

Active Comparator group

Description:

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.

Treatment:

Device: Arizant Healthcare Bair Hugger Temperature Management System