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

NCT03851510 | Terminated Results

• 1 other identifier: VectorEFLScreening-2018-10242
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Obstructive Pulmonary Disease; Noninvasive Ventilation

Outcome Measures

Primary Outcomes (1)

• Overall Prevalence of Expiratory Flow Limitation

  The overall prevalence of EFL will be determined. This is defined as the percentage of participants exhibiting a DeltaXRS value greater than or equal to 2.8 using the Vector EFL device while supine. For purposes of this trial, overall prevalence includes indeterminate EFL and EFL.

  1 day

Secondary Outcomes (3)

• Correlation of Titrated Final EPAP to Participants' Forced Expiratory Volume in One Second (FEV1)

  1 day

• Correlation of Titrated Final EPAP to Participants' Screening DeltaXrs Value

  1 day

• Percent of Participants With EFL Per the Resmon Pro That Have Their EFL Abolished During the Vector Screening.

  1 day

Study Arms (2)

Resmon Pro

ACTIVE COMPARATOR

COPD participants will be first screened for Expiratory Flow Limitation using the Resmon Pro.

Device: Resmon Pro

Vector Ventilator

EXPERIMENTAL

COPD participants will be screened again for Expiratory Flow Limitation using the Vector device, participants with EFL will undergo 20 minute titration protocol for therapy.

Device: Vector ventilator

Interventions

Vector ventilator DEVICE

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.

Vector Ventilator

Resmon Pro DEVICE

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

Resmon Pro

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 40 years of age; \< 80 years of age
• Ability to provide consent
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)

You may not qualify if:

• Any major non COPD uncontrolled disease or condition, such as congestive heart failure, malignancy, liver or renal insufficiency (that requires current evaluation for liver or renal transplantation or dialysis), amyotrophic lateral sclerosis, or severe stroke, or other condition as deemed appropriate by investigator as determined by review of medical history and / or participant reported medical history
• Suffering from a COPD exacerbation at the time of data collection or in the 30 days prior to data collection
• Self-reported Pregnancy
• Employee or family member that is affiliated with Philips Respironics
• History of bullous emphysema
• History of pneumothorax
• Evidence of acute sinusitis or otitis media
• Hypotension
• Participants at risk for aspiration of gastric contents
• Epistaxis
• Participants in respiratory failure
• Inability to maintain a patent airway or adequately clear secretions

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (1)

University of Florida, Jacksonville

Jacksonville, Florida, 32209, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chuck Cain
• Organization: Philips

chuck.cain@philips.com

412-657-1814

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are first getting screened with Resmon Pro they then will be screened with the Vector ventilator for EFL. Those that screen positive with EFL with the Vector ventilator will be treated with the vector device with a 20 minute titration protocol.

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 22, 2019
• Study Start: March 14, 2019
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)