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

NCT01188590 | Completed

• 1 other identifier: 009-220
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Respiratory Insufficiency

Keywords

Post operative Respiratory insufficiency

Outcome Measures

Primary Outcomes (1)

• Determine the baseline TcPCO2 levels for first 24 hours post ICU of cardiac surgery patients.

  24 hours

Secondary Outcomes (1)

• Classify levels of hypercarbia found

  24 hours

Study Arms (1)

Patients undergoing heart surgery

Device: TOSCA 500 monitor

Interventions

TOSCA 500 monitor DEVICE

transcutaneous ear lobe probe that monitors pulse rate, oxygen saturation and carbon dioxide levels

Patients undergoing heart surgery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cardiovascular surgical patients at Baylor University Medical Center

You may qualify if:

• ASA Class 1, 2, 3, or 4 men and women who are having cardiac surgery by one of the participating surgeons

You may not qualify if:

• 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;
• 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);
• Subject has a condition or allergy which would prohibit placing the probe on the earlobes;
• Subject is unable to undergo any procedure required by the protocol;
• Subject has any other condition or factor which, in the Investigator's opinion, might increase the risk to the subject; or
• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Michael A Ramsay, MD, FRCA

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 25, 2010
• Study Start: November 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 13, 2016

Record last verified: 2016-01

Locations

US (1)