Pilot Study of the Genius(TM)2 Tympanic Thermometer in Cardiac Patients Requiring Cardiopulmonary Bypass
This study has been completed.
Information provided by:
Tyco Healthcare Group
First received: December 7, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
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.
Cardiac Surgical Procedures
||Observational Model: Cohort
Time Perspective: Prospective
||Pilot Study of the Genius(TM)2 Tympanic Thermometer in Cardiac Patients Requiring Cardiopulmonary Bypass
Primary Outcome Measures:
- Thermometer accuracy and precision: 1) Temperature obtained by Genius 2 and Exergen compared to core body temperature (accuracy). 2) Agreement among temperatures taken in triplicate at a given time point (precision). [ Time Frame: Subjects are followed for temperature collection until 6 hours post admission to the intensive care unit; lab data and patient outcomes are collected until the time of hospital discharge. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Effect of environmental conditions before, during and after surgery, on body temperature and thermometer performance (ambient temperature, humidity, diaphoresis, warming devices). [ Time Frame: Predetermined perioperative time periods up to 6 hours after intensive care unit admission. ] [ Designated as safety issue: No ]
- Explore possible relationships between temperature management and duration of CABG surgery and the following patient outcomes: mortality, renal failure (new onset), stroke, myocardial infarction, length of hospital stay, length of ICU stay. [ Time Frame: Predetermined perioperative time periods until hospital discharge. ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2009 (Final data collection date for primary outcome measure)
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).
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Adults greater than/equal to 18 years of age scheduled for a cardiac surgical procedure requiring cardiopulmonary bypass.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029314
|Massachusetts General Hospital
|Boston, Massachusetts, United States, 02114 |
Tyco Healthcare Group
||Edwin Avery, MD
||Massachusetts General Hospital Corporation
No publications provided
||Edwin Avery IV, MD, Principal Investigator, Massachusetts General Hospital Corporation
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 7, 2009
||December 7, 2009
||United States: Institutional Review Board
Keywords provided by Tyco Healthcare Group:
ClinicalTrials.gov processed this record on March 06, 2014