Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients

March 16, 2018 updated by: Carolyn Miller Reilly, Emory University
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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
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.
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.
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)
Time Frame: Up to 2 Weeks
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)
Time Frame: Up to 2 Weeks
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
Time Frame: Up to 2 Weeks
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
Time Frame: Up to 2 Weeks
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carolyn Reilly, PhD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • IRB00082202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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