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).

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cardiovascular surgical patients at Baylor University Medical Center

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine the baseline TcPCO2 levels for first 24 hours post ICU of cardiac surgery patients.	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Classify levels of hypercarbia found	24 hours

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: Michael A Ramsay, MD, FRCA, Baylor Health Care System

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (ACTUAL): January 1, 2010
• Study Completion (ACTUAL): January 1, 2010

Study Registration Dates

• First Submitted: August 24, 2010
• First Submitted That Met QC Criteria: August 24, 2010
• First Posted (ESTIMATE): August 25, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 13, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Post operative Respiratory insufficiency
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 009-220