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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgical Procedures

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: Tyco Healthcare Group
• Investigators: Principal Investigator: Edwin Avery, MD, Massachusetts General Hospital Corporation

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: December 7, 2009
• First Submitted That Met QC Criteria: December 7, 2009
• First Posted (Estimate): December 9, 2009

Study Record Updates

• Last Update Posted (Estimate): December 9, 2009
• Last Update Submitted That Met QC Criteria: December 7, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Thermometry
• Other Study ID Numbers: 353.29