Comparison Study of Intraoperative Patient Warming Systems

NCT00670826 | Unknown

• 2 other identifiers: M100 IRB07-003313TP0010C
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Surgery; General Anesthesia

Keywords

Patient warming

Outcome Measures

Primary Outcomes (1)

• Compare esophageal temperatures after 60 minutes of warming with each system

  60 minutes of patient warming

Secondary Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Interventions

vitalHEAT vH2 Temperature Management System DEVICE

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.

1

Arizant Healthcare Bair Hugger Temperature Management System DEVICE

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pts undergoing orthopedic surgical procedure with expected duration 2-3 hrs
• General anesthesia required
• ASA physical status I-III

You may not qualify if:

• 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

Sponsors & Collaborators

• Dynatherm Medical Inc.: lead

Study Sites (1)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

Study Officials

• Kent P Weinmeister, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kent P Weinmeister, MD

CONTACT

480-342-2446; weinmeister.kent@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 2, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 2, 2008

Record last verified: 2008-04

Locations

US (1)