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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014