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Determination of the Prevalence and Severity of Expiratory Flow Limitation in Chronic Obstructive Pulmonary Disease Patients

NCT03851510 · Status: TERMINATED · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2024-10-24

Study results available
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Summary

Expiratory Flow Limitation (EFL) occurs when the airways become compressed, which usually results when the pressure outside the airway exceeds the pressure inside the airway. EFL can be detected using the Forced Oscillation Technique (FOT), which has been incorporated into a new screening feature in the Philips Respironics BiPAP Ventilator overall platform (Vector Non-Invasive (NIV) device). In this study, the Vector device will be used in a cross-sectional non-randomized epidemiology study to assess the prevalence and severity of expiratory flow limitation in a community COPD population. The study will also investigate how the presence of EFL may correlate with other physiological biomarker endpoints in the COPD patient. Participants will include 100 male and females with a diagnosis of COPD between the ages of 40 and 80. During the one-visit study, participants will undergo an EFL screening using the Vector device. If EFL is not detected during the screening after 5 minutes, the participant will not continue. If EFL is detected by the device, the participant will continue to wear it while it measures the level of therapy that is needed to eliminate EFL. Twenty minutes of pressure therapy will then be provided and the final Expiratory Positive Airway Pressure (EPAP) that is determined to abolish the participants EFL will be recorded. Participant characteristics (e.g. health history, behaviors, anthropometric, vitals, etc.) will be also be collected via questionnaires, medical record review, and physical exam. Future benefits of the study will be to gain a better understanding of the Vector screening feature and the characteristics of patients who present with varying degrees of EFL severity.

Conditions

Interventions

DEVICE

Vector ventilator

The Vector ventilator is intended to provide non-invasive ventilatory support to treat adult patients with Obstructive Sleep Apnea (OSA), or Respiratory Insufficiency with the primary cause being COPD. This device is not intended for life support. It may be used to screened for the presence and abolishment of expiratory flow limitation. It is intended to be used within the home, institution/hospital, and diagnostic laboratory environments. The vector ventilator will titrate and treat EFL using non-invasive ventilatory support.

DEVICE

Resmon Pro

The Resmon Pro uses the forced oscillation technique (FOT) which is a noninvasive method to measure the mechanical properties of the lung and airways during tidal breathing. In addition to measuring total impedance (resistance and reactance), the Resmon Pro can measure expiratory flow limitation which is a key index of respiratory obstruction

Sponsors & Collaborators

  • Philips Respironics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-14
Primary Completion
2023-11-15
Completion
2023-11-15

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03851510 on ClinicalTrials.gov