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Completed

NCT Number: NCT01188590

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

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Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor University Medical Center

Dallas, Texas, 75246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

TOSCA 500 monitor

Device

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

Primary outcomes

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

    Time frame: 24 hours

Secondary outcomes

  1. Classify levels of hypercarbia found

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 25, 2010
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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