Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients

Emory University

Status: Withdrawn

Conditions: Cardiomyopathy; Heart Disease; Cardiovascular Disease

Treatments: Other: Standard Non-invasive Respiratory Depression Monitoring; Device: Respiratory Depression Monitoring with End Tidal Carbon Dioxide Nasal Cannula (ETCO2- NC)

Study type: Interventional

Funder types: Other

Identifiers

NCT02838355

IRB00082202

Details and patient eligibility

About

The purpose of this study is to explore how the End Tidal Carbon Dioxide monitoring via nasal cannula (ETCO2-NC) device may allow for earlier detection of respiratory complications. This device will detect the amount of carbon dioxide exhaled with each breath and may better predict high levels of this than traditional monitoring. This may reduce the number and severity of respiratory issues. A convenience sample of 60 participants either scheduled for continuous flow left ventricular assist device (CF-LVAD) implant or who have been readmitted to an ICU with a CF-LVAD will be recruited and randomized to usual care or usual care plus ETCO2-NC throughout their stay in the ICU.

Full description

The purpose of this proposal is to explore the relationships between End Tidal Carbon Dioxide (ETCO2) via nasal cannula (ETCO2-NC) and routinely measured physiologic and participant reported parameters in extubated participants who have received a continuous flow left ventricular assist device (CF-LVAD), and to determine if the addition of ETCO2-NC monitoring to usual care is associated with decreased incidence and severity of respiratory issues.

A convenience sample of 60 participants either scheduled for mechanical circulatory support device (MCSD) implant or who have been readmitted to an intensive care unit (ICU) with a CF-LVAD will be recruited and randomized to usual care or usual care plus ETCO2-NC throughout their stay in the ICU.

Investigators seek to examine the relationship between ETCO2-NC with traditional physiologic measures, clinical assessments, and participant reported symptoms in persons with a CF-LVAD. Additionally, this study intends to compare the respiratory outcomes of extubated persons with a CF-LVAD randomized to usual care to those receiving usual care plus ETCO2- NC.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled for mechanical circulatory support device (MCSD) implant or have been readmitted to an intensive care unit (ICU) with a continuous flow left ventricular assist device (CF-LVAD)
• New York Heart Association (NYHA) functional class III to IV
• Ability to read, write, and speak English

Exclusion criteria

• Requiring mechanical ventilation during the active phase of the trial

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard Respiration Monitoring

Active Comparator group

Description:

Participants scheduled for mechanical circulatory support device (MCSD) implant or who have been readmitted to an intensive care unit (ICU) with a continuous flow left ventricular assist device (CF-LVAD) will receive standard respiratory monitoring throughout their stay in the ICU.

Treatment:

Other: Standard Non-invasive Respiratory Depression Monitoring

Standard Respiration Monitoring + Continuous ETCO2-NC

Experimental group

Description:

Participants scheduled for mechanical circulatory support device (MCSD) implant or who have been readmitted to an intensive care unit (ICU) with a continuous flow left ventricular assist device (CF-LVAD) will receive standard respiratory monitoring and continuous end-tidal capnography monitoring via nasal cannula (ETCO2-NC) throughout their stay in the ICU.

Treatment:

Device: Respiratory Depression Monitoring with End Tidal Carbon Dioxide Nasal Cannula (ETCO2- NC)

Other: Standard Non-invasive Respiratory Depression Monitoring