MedDataX Logo

Comparison of Intraoperative Warming Devices

NCT ID: NCT00711867

Last Updated: 2009-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-12-31

Brief Summary

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

The sublingual (under the tongue) core temperature within 10 minutes of arrival in the post anesthesia care unit (PACU) for patients warmed with the Dynatherm vitalHeat2 (VH2) System under general anesthesia for total knee arthroplasty will be equivalent to that of patients 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.

Total Knee Arthroplasty

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

PREVENTION

Blinding Strategy

NONE

Study Groups

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

VH2

Dynatherm vitalHeat2 (VH2) temperature management system.

Group Type EXPERIMENTAL

VH2

Intervention Type DEVICE

Dynatherm vitalHeat2 (VH2) temperature management system.

Bair Hugger

Arizant Bair Hugger temperature management system.

Group Type ACTIVE_COMPARATOR

Bair Hugger

Intervention Type DEVICE

Arizant Bair Hugger temperature management system.

Interventions

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

VH2

Dynatherm vitalHeat2 (VH2) temperature management system.

Intervention Type DEVICE

Bair Hugger

Arizant Bair Hugger temperature management system.

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Initial total knee arthroplasty.
* Expected duration of surgery at least 2 hours.
* General anesthesia.
* American Society of Anesthesiologists (ASA) classification I-III.
* Age \>= 18 years.

Exclusion Criteria

* Skin abrasion at the device application site.
* History of peripheral vascular disease.
* History of allergic skin conditions of the upper extremities.
* History of malignant hyperthermia.
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 collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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

Mayo Clinic

Principal Investigators

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

Kent Weinmeister, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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

Mayo Clinic

Phoenix, Arizona, United States

Site Status

Countries

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

United States

References

Explore related publications, articles, or registry entries linked to this study.

Trentman TL, Weinmeister KP, Hentz JG, Laney MB, Simula DV. Randomized non-inferiority trial of the vitalHEAT temperature management system vs the Bair Hugger warmer during total knee arthroplasty. Can J Anaesth. 2009 Dec;56(12):914-20. doi: 10.1007/s12630-009-9199-2. Epub 2009 Sep 25.

Reference Type DERIVED
PMID: 19779953 (View on PubMed)

Other Identifiers

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

07-003313

Identifier Type: -

Identifier Source: org_study_id