Clinical trial NCT01029314: Pilot Study of the Genius(TM)2 Tympanic Thermometer in Cardiac Patients Requiring Cardiopulmonary Bypass
Official title: Pilot Study of the Genius(TM)2 Tympanic Thermometer in Cardiac Patients Requiring Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgical Procedures
Keywords: Thermometry
Lead sponsor: Tyco Healthcare Group
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: 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 outcomes:
measure: Effect of environmental conditions before, during and after surgery, on body temperature and thermometer performance (ambient temperature, humidity, diaphoresis, warming devices).
timeFrame: Predetermined perioperative time periods up to 6 hours after intensive care unit admission.
measure: 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.
timeFrame: Predetermined perioperative time periods until hospital discharge.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital Corporation
name: Edwin Avery, MD
role: PRINCIPAL_INVESTIGATOR
References: