NCT02838355

Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Cardiomyopathy
• Cardiovascular Disease
• Heart Disease

Interventions

Type	Name	Description
DEVICE	Respiratory Depression Monitoring with End Tidal Carbon Dioxide Nasal Cannula (ETCO2- NC)	The ETCO2-NC is a non-invasive device that monitors the amount of carbon dioxide that is exhaled with every breath.
OTHER	Standard Non-invasive Respiratory Depression Monitoring	Standard non-invasive respiration monitoring includes telemetry of heart rate and rhythm, respiratory rate, blood pressure, CF-LVAD flow, and oxygen saturation (SpO2) via pulse oximetry.

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2016-07-20
• Last updated: 2018-03-20

Locations

1 site across 1 country: United States