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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01188590
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : January 13, 2016
Information provided by (Responsible Party):
Baylor Research Institute

August 24, 2010
August 25, 2010
January 13, 2016
November 2009
January 2010   (Final data collection date for primary outcome measure)
Determine the baseline TcPCO2 levels for first 24 hours post ICU of cardiac surgery patients. [ Time Frame: 24 hours ]
Same as current
Complete list of historical versions of study NCT01188590 on Archive Site
Classify levels of hypercarbia found [ Time Frame: 24 hours ]
Same as current
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Transcutaneous Carbon Dioxide Monitoring Post Cardiac Surgery: Incidence and Severity Resp Insufficiency
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.
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample
Cardiovascular surgical patients at Baylor University Medical Center
Respiratory Insufficiency
Device: TOSCA 500 monitor
transcutaneous ear lobe probe that monitors pulse rate, oxygen saturation and carbon dioxide levels
Patients undergoing heart surgery
Intervention: Device: TOSCA 500 monitor
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2010
January 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Baylor Research Institute
Baylor Research Institute
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Principal Investigator: Michael A Ramsay, MD, FRCA Baylor Health Care System
Baylor Research Institute
January 2016