Clinical trial NCT02838355: Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients
Official title: Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiomyopathy
Cardiovascular Disease
Heart Disease
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory Distressed assessed by Respiratory Distress Observation Scale (RDOS)
timeFrame: Up to 2 Weeks
measure: Dyspnea Rate assessed by the Dyspnea Visual Analogue Scale (DVAS)
timeFrame: Up to 2 Weeks
measure: Incidence of Respiratory Depression
timeFrame: Up to 2 Weeks
measure: Severity of Respiratory Depression
timeFrame: Up to 2 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Carolyn Reilly, PhD
role: PRINCIPAL_INVESTIGATOR
References: