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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

Brief Summary:
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).

Condition or disease Intervention/treatment
Respiratory Insufficiency Device: TOSCA 500 monitor

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pilot Study: Transcutaneous Carbon Dioxide Monitoring Post Cardiac Surgery: Incidence and Severity of Respiratory Insufficiency
Study Start Date : November 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patients undergoing heart surgery Device: TOSCA 500 monitor
transcutaneous ear lobe probe that monitors pulse rate, oxygen saturation and carbon dioxide levels

Primary Outcome Measures :
  1. Determine the baseline TcPCO2 levels for first 24 hours post ICU of cardiac surgery patients. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Classify levels of hypercarbia found [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cardiovascular surgical patients at Baylor University Medical Center

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01188590

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United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
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Principal Investigator: Michael A Ramsay, MD, FRCA Baylor Health Care System

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Responsible Party: Baylor Research Institute Identifier: NCT01188590    
Other Study ID Numbers: 009-220
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016
Keywords provided by Baylor Research Institute:
Post operative Respiratory insufficiency
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases