Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients

Cardiovascular Disease Clinical Trial

Official title:

Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02838355
• Other study ID #: IRB00082202
• Status: Withdrawn
• Phase: N/A
• First received: May 17, 2016
• Last updated: March 16, 2018
• Start date: October 2016
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Cardiovascular Disease
• Cardiovascular Diseases
• Heart Disease
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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