Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiovascular Disease; Heart Disease; Cardiomyopathy
• Intervention / Treatment: Other: Standard Non-invasive Respiratory Depression Monitoring; Device: Respiratory Depression Monitoring with End Tidal Carbon Dioxide Nasal Cannula (ETCO2- NC)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Respiration Monitoring; 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.	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.
Experimental: Standard Respiration Monitoring + Continuous ETCO2-NC; 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.	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.; 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 Names: ETCO2- NC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Distressed assessed by Respiratory Distress Observation Scale (RDOS)	The RDOS is an ordinal level scale with eight observer-rated parameters: heart rate, respiratory rate, accessory muscle use, paradoxical breathing pattern, restlessness, grunting at end-expiration, nasal flaring, and a fearful facial display. Each parameter is scored from 0 to 2 points and the points are summed. Scale scores range from 0 signifying no distress to 16 signifying the most severe distress.	Up to 2 Weeks
Dyspnea Rate assessed by the Dyspnea Visual Analogue Scale (DVAS)	The DVAS is a self-reported scale that asks participants to indicate how much shortness of breath they are experiencing by marking on a line 100 mm in length between "no shortness of breath" and "shortness of breath as bad as can be".	Up to 2 Weeks
Incidence of Respiratory Depression	This is physiologic data abstracted from the medical record: respiration that has a rate below 12 breaths per minute or that fails to provide full ventilation and perfusion of the lungs.	Up to 2 Weeks
Severity of Respiratory Depression	Physiologic data abstracted from the medical record: Severity of respiration depression will be collected via standard hospital code met and code blue forms. Respiratory compromise will be defined as respiratory rate increase or decrease by 20% or greater, an ETCO2 value greater than 20% above baseline values, or a SpO2 less than 90% for greater than 10 seconds.	Up to 2 Weeks

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Carolyn Reilly, PhD, Emory University

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: July 17, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: IRB00082202