Transcutaneous Carbon Dioxide Monitoring Post Cardiac Surgery: Incidence and Severity Resp Insufficiency



Status:Completed
Conditions:Cardiology, Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 85
Updated:4/21/2016
Start Date:November 2009
End Date:January 2010

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Pilot Study: Transcutaneous Carbon Dioxide Monitoring Post Cardiac Surgery: Incidence and Severity of Respiratory Insufficiency

The purpose for the investigators study is to investigate the severity and incidence of
respiratory insufficiency using transcutaneous carbon dioxide (TcPCO2) monitoring as an
adjunct to the current standard of care for early detection of inadequate ventilation in
post-operative surgical in-patients undergoing cardiac surgery after discharge from
intensive care unit (ICU) or post anesthesia recovery unit (PACU).

This observational study is to determine the baseline carbon dioxide and severity of
respiratory distress and acute respiratory failure (ARF)/respiratory arrest in the post
cardiac surgery patients in the first 24 hours on a monitored telemetry floor.

Inclusion Criteria:

- ASA Class 1, 2, 3, or 4 men and women who are having cardiac surgery by one of the
participating surgeons

Exclusion Criteria:

1. Subject has participated in a trial with any experimental drug or device trial within
30 days prior to enrollment in the study, or has ever been enrolled in this study;

2. Subject has a condition that would require an extensive amount of time off of 13
Roberts during the first 24 hours of admission to the telemetry unit. (e.g.,
hemodialysis);

3. Subject has a condition or allergy which would prohibit placing the probe on the
earlobes;

4. Subject is unable to undergo any procedure required by the protocol;

5. Subject has any other condition or factor which, in the Investigator's opinion, might
increase the risk to the subject; or

6. If female, subject is non-lactating, and is either:

- Not of childbearing potential, defined as postmenopausal for at least 1 year or
surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or
hysterectomy; or

- Of childbearing potential but is not pregnant as confirmed by negative serum
pregnancy test at time of screening.
We found this trial at
1
site
3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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Dallas, TX
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