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

NCT ID: NCT01188590

Last Updated: 2016-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-01-31

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).

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.

Conditions

Respiratory Insufficiency

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients undergoing heart surgery

TOSCA 500 monitor

Intervention Type: DEVICE

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

Interventions

TOSCA 500 monitor

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael A Ramsay, MD, FRCA

Role: PRINCIPAL_INVESTIGATOR

Baylor Health Care System

Locations

Baylor University Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

009-220

Identifier Type: -

Identifier Source: org_study_id