Cardiac Surgical Procedures
Conditions
Keywords
Thermometry
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.
Interventions
None listed
Sponsors
Tyco Healthcare Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | 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
| Measure | Time frame |
|---|---|
| Effect of environmental conditions before, during and after surgery, on body temperature and thermometer performance (ambient temperature, humidity, diaphoresis, warming devices). | Predetermined perioperative time periods up to 6 hours after intensive care unit admission. |
| 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. | Predetermined perioperative time periods until hospital discharge. |
Countries
United States
Outcome results
None listed