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

Cardiac Surgical Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029314
• Other study ID #: 353.29
• Status: Completed
• Phase: N/A
• First received: December 7, 2009
• Last updated: December 7, 2009
• Start date: May 2008
• Est. completion date: June 2009

Study information

• Verified date: December 2009
• Source: Tyco Healthcare Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Surgical Procedures

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tyco Healthcare Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No