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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01029314
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : December 9, 2009
Information provided by:
Tyco Healthcare Group

Brief Summary:
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.

Condition or disease
Cardiac Surgical Procedures

Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of the Genius(TM)2 Tympanic Thermometer in Cardiac Patients Requiring Cardiopulmonary Bypass
Study Start Date : May 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

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).

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults greater than/equal to 18 years of age scheduled for a cardiac surgical procedure requiring cardiopulmonary bypass.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01029314

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Tyco Healthcare Group
Principal Investigator: Edwin Avery, MD Massachusetts General Hospital Corporation

Responsible Party: Edwin Avery IV, MD, Principal Investigator, Massachusetts General Hospital Corporation Identifier: NCT01029314     History of Changes
Other Study ID Numbers: 353.29
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: December 9, 2009
Last Verified: December 2009

Keywords provided by Tyco Healthcare Group: