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

NCT ID: NCT03851510

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-14
• Study Completion Date: 2023-11-15

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.

Detailed Description

This will be a cross-sectional, non-randomized epidemiology study designed to assess the prevalence and severity of expiratory flow limitation in a community COPD population. In the study we will also investigate how the presence EFL may correlate to other physiological biomarker endpoints in the COPD patient.

Schedule of Events:

Study Visit

• Once the participant arrives, the study will be explained in full detail. If the participant agrees, he/she will be consented into the study and the participant will be given a copy of the informed consent.
• Once consent is obtained, and eligibility is confirmed the following study related procedures will be conducted:
• Demographics: gender, date of birth, ethnicity, race, level of education will be collected.
• Current Medications: all current medications will be collected.
• Medical History Assessment: information will be collected regarding historical spirometry data, COPD history and other relevant medical history including the diagnosis of Sleep disordered breathing and Oxygen therapy usage. Chest computerized tomography (CT) scans will be collected if they have not been done within the past two years. A new CT scan will not be required.
• Physical examination with anthropometric data (weight, height and temperature) collected and vital signs to include Heart Rate (HR),Blood Pressure (BP), Respiratory Rate (RR), and Oxygen Saturation (SPO2) maintained at least 88% on room air, and chest auscultation.
• Review of inclusion/exclusion to ensure participant is eligible to continue
• Administration of Study Questionnaires
• Mask Fitting: Participants will have up to two mask fittings in order to determine the best possible masks while using the Vector NIV device during the EFL screening and titration.
• Spirometry testing will be performed for participants who have not had a test in the previous 6 months Resmon Pro EFL Measurement
• Participants will be required to wear nose clips during the measurement
• Participants will also be required to hold their cheeks during the measurement to prevent any air leaks around their mouth.
• While seated, participants will be instructed to breathe normally into the device for at least 30 seconds or until at least 10 breaths were successfully accepted by the device
• Participants will be asked to repeat test while in the supine or semi-recumbent position.

Vector EFL Screening/Determination and EPAP Titration

• EFL Determination: The participant will be asked to breathe quietly into the Vector device using the selected mask for 5 minutes in the seated position, and then an additional 5 minutes while in supine or semi-recumbent position. This device has the capability of detecting EFL. If it is determined that the participant does not have EFL by the device screening indicator, the participant will not continue with the EPAP titration.
• EPAP Titration: if it is determined by the Vector NIV device that the participant has EFL, the Vector NIV device will be changed from screening mode to therapy mode to delivery BiPAP therapy with the following settings.

Vector Device Settings:

• Pressure Support 6 cmH2O
• Max Pressure 26 cmH2O
• EPAP Min / EPAP Max 4 / 20 cmH2O
• The participants will then breathe on the Vector NIV device in the supine position (preferred) or semi-recumbent if needed for approximately an additional 20 minutes. During the additional 20 minutes of breathing, the device will automatically increase the EPAP (and concurrently and proportionally the IPAP) until the EFL is abolished (or falls below the predetermined EFL threshold).
• While the automatic EPAP Titration is being performed, all participants' SpO2 will be monitored via finger pulse oximetry.
• Patient must stay awake during the EPAP Titration. If the patient falls asleep, they will be woken by study staff.
• The Final EPAP that is determined to abolish the participants EFL will be recorded
• Participants will complete an EFL Vector device post questionnaire

Conditions

Chronic Obstructive Pulmonary Disease; Noninvasive Ventilation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Resmon Pro

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

Group Type: ACTIVE_COMPARATOR

Resmon Pro

Intervention Type: 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

Vector Ventilator

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.

Group Type: EXPERIMENTAL

Vector ventilator

Intervention Type: 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.

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Respironics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Florida, Jacksonville

Jacksonville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

VectorEFLScreening-2018-10242

Identifier Type: -

Identifier Source: org_study_id