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

Respiratory Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188590
• Other study ID #: 009-220
• Status: Completed
• Phase: N/A
• First received: August 24, 2010
• Last updated: January 11, 2016
• Start date: November 2009
• Est. completion date: January 2010

Study information

• Verified date: January 2016
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• TOSCA 500 monitor
transcutaneous ear lobe probe that monitors pulse rate, oxygen saturation and carbon dioxide levels

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the baseline TcPCO2 levels for first 24 hours post ICU of cardiac surgery patients.		24 hours	No
Secondary	Classify levels of hypercarbia found		24 hours	No