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NCT03851510 · ClinicalTrials.gov registry record
Determination of the Prevalence and Severity of Expiratory Flow Limitation in Chronic Obstructive Pulmonary Disease Patients
A clinical trial, sponsored by Philips Respironics.
- Terminated
- Registry status
- 57
- Enrollment target
NCT03851510: Clinical Trial study, sponsored by Philips Respironics.
NCT03851510 is a clinical trial that was terminated before completion, run by Philips Respironics. The registered enrollment target is 57 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03851510 was terminated before completion, sponsored by Philips Respironics.
- TERMINATED
- Registry status
- 57 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE Vector ventilator
- DEVICE Resmon Pro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2019-03-14 |
| Est. Completion | 2023-11-15 |
Why NCT03851510 stopped before completion
NCT03851510 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Vector ventilator is the first listed.
NCT03851510 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03851510 about?
NCT03851510 is a clinical study titled "Determination of the Prevalence and Severity of Expiratory Flow Limitation in Chronic Obstructive Pulmonary Disease Patients". 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...
What is the current status of trial NCT03851510?
This trial is currently terminated. The enrollment target is 57 participants. The study started on 2019-03-14. Estimated completion is 2023-11-15.
What interventions are being tested in trial NCT03851510?
The interventions under investigation include: Vector ventilator (DEVICE), Resmon Pro (DEVICE).
Who is sponsoring clinical trial NCT03851510?
This trial is sponsored by Philips Respironics, which has 35 total clinical trials registered on ClinicalTrials.gov.
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