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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01188590
First received: August 24, 2010
Last updated: January 11, 2016
Last verified: January 2016
  Purpose
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 Intervention
Respiratory Insufficiency
Device: TOSCA 500 monitor

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pilot Study: Transcutaneous Carbon Dioxide Monitoring Post Cardiac Surgery: Incidence and Severity of Respiratory Insufficiency

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • Determine the baseline TcPCO2 levels for first 24 hours post ICU of cardiac surgery patients. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Classify levels of hypercarbia found [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: November 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients undergoing heart surgery Device: TOSCA 500 monitor
transcutaneous ear lobe probe that monitors pulse rate, oxygen saturation and carbon dioxide levels

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.
  Eligibility

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

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01188590

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

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01188590     History of Changes
Other Study ID Numbers: 009-220 
Study First Received: August 24, 2010
Last Updated: January 11, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor Research Institute:
Post operative Respiratory insufficiency

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 30, 2016