Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients

NCT02838355 | Withdrawn

• 1 other identifier: IRB00082202
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy; Cardiovascular Disease; Heart Disease

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Standard Respiration Monitoring

ACTIVE COMPARATOR

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 Respiration Monitoring + Continuous ETCO2-NC

EXPERIMENTAL

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.

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

Interventions

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

The ETCO2-NC is a non-invasive device that monitors the amount of carbon dioxide that is exhaled with every breath.

Also known as: ETCO2- NC

Standard Respiration Monitoring + Continuous ETCO2-NC

Standard Non-invasive Respiratory Depression Monitoring OTHER

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.

Standard Respiration Monitoring; Standard Respiration Monitoring + Continuous ETCO2-NC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Requiring mechanical ventilation during the active phase of the trial

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Cardiomyopathies; Cardiovascular Diseases; Heart Diseases

Study Officials

• Carolyn Reilly, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: July 20, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

US (1)