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

This study has been completed.
Sponsor:
Information provided by:
Tyco Healthcare Group
ClinicalTrials.gov Identifier:
NCT01029314
First received: December 7, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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
Cardiac Surgical Procedures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of the Genius(TM)2 Tympanic Thermometer in Cardiac Patients Requiring Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Tyco Healthcare Group:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: May 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029314

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

No publications provided

Responsible Party: Edwin Avery IV, MD, Principal Investigator, Massachusetts General Hospital Corporation
ClinicalTrials.gov Identifier: NCT01029314     History of Changes
Other Study ID Numbers: 353.29
Study First Received: December 7, 2009
Last Updated: December 7, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Tyco Healthcare Group:
Thermometry

ClinicalTrials.gov processed this record on April 14, 2014