MedDataX Logo

Comparison Study of Intraoperative Patient Warming Systems

NCT ID: NCT00670826

Last Updated: 2008-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Orthopedic Surgery General Anesthesia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Patient warming

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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.

Group Type EXPERIMENTAL

vitalHEAT vH2 Temperature Management System

Intervention Type 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.

2

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.

Group Type ACTIVE_COMPARATOR

Arizant Healthcare Bair Hugger Temperature Management System

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vitalHEAT 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.

Intervention Type DEVICE

Arizant 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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dynatherm Medical Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mayo Clinic Scottsdale

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kent P Weinmeister, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic Hospital

Phoenix, Arizona, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kent P Weinmeister, MD

Role: CONTACT

Phone: 480-342-2446

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TP0010C

Identifier Type: -

Identifier Source: secondary_id

M100 IRB07-003313

Identifier Type: -

Identifier Source: org_study_id