Pilot Study of the Genius(TM)2 Tympanic Thermometer in Cardiac Patients Requiring Cardiopulmonary Bypass
This study has been completed.
Sponsor:
Tyco Healthcare Group
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
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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 |
|---|
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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 |
|---|
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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).
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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 May 19, 2013