Pilot Study of the Genius(TM)2 Tympanic Thermometer in Cardiac Patients Requiring Cardiopulmonary Bypass

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

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-06-30

Brief Summary

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Primary study objective is to test the accuracy of the Genius 2 tympanic thermometer and the Exergen TAT-5000(TM) temporal artery thermometer as compared with serial perioperative core temperature measurements obtained in cardiac surgical patients during cardiopulmonary bypass. Study hypothesis: The Genius 2 thermometer will display greater precision and accuracy than the Exergen TAT-5000 thermometer when compared to core body temperature in patients undergoing CABG surgery.

Detailed Description

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Conditions

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Cardiac Surgical Procedures

Keywords

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Thermometry

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiopulmonary bypass surgery

Thirty to fifty cardiac surgery patients undergoing cardiopulmonary bypass will have serial triplicate temperatures taken by both the Genius 2 tympanic thermometer and the Exergen-TAT 5000 temporal artery thermometer at predetermined perioperative time points. These temperature readings will be compared to at least one core temperature (i.e., pulmonary artery).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male or female adult subjects greater than/equal to 18 years of age providing signed informed consent
* Febrile or afebrile
* Planned monitoring of core temperature at a minimum of two separate sites, one of which includes the pulmonary artery
* Planned use of cardiopulmonary bypass for a cardiac surgical procedure.

Exclusion Criteria

* Mist tents or oxygen hoods
* Hot or cold applications to the head
* Patients that have the planned use of deep hypothermic circulatory arrest
* Aural anomalies (e.g., external auditory canal less than 2cm in length, persistent ear pain)
* Any other major anomaly, surgery or medical condition precluding participation according to manufacturers' stated exclusions or in the opinion of the principal investigator
* Blood, cerumen, excessive hair, inflammation, infection, ulceration or foreign object in the ear observed by otoscopic examination
* Any other signs or symptoms of distress or a condition which would, or in the opinion of the principal investigator, render their participation in the study detrimental to their well-being.
* Previous refusal or enrollment in this study
* Previous or concurrent participation in a clinical trial of a drug or device within the past 30 days.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Massachusetts General Hospital Corporation

Principal Investigators

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Edwin Avery, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital Corporation

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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353.29

Identifier Type: -

Identifier Source: org_study_id