Pilot Study of the Genius(TM)2 Tympanic Thermometer in Cardiac Patients Requiring Cardiopulmonary Bypass
Completed
Conditions studied: Cardiac Surgical Procedures
In brief
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.
Key facts
- Study ID
- NCT01029314
- Run by
- Tyco Healthcare Group
- People needed
- 33
- Starts
- 2008-05-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2009-12-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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