CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
Auto-Titrating EPAPdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04725500
NCT04725500N/ACompleted

Engineering Evaluation of the Vector NIV Device in Chronic Obstructive Pulmonary Disease (COPD) Patients

Philips Clinical & Medical Affairs Global·interventional·Posted Jan 26, 2021·Updated May 26, 2021

In Brief

A clinical study evaluating Auto-Titrating EPAP for COPD. Completed, enrolled 42 participants across 2 sites.

Detailed Summary

This study aimed to validate a novel automatic non-invasive ventilation (NIV) mode that continuously adjusts expiratory positive airway pressure (EPAP) to the lowest value that abolishes tidal expiratory flow limitation (EFL). The investigator conducted a prospective, non-randomized, study on stable chronic obstructive pulmonary disease (COPD) patients that may or may not be treated currently with NIV. Patients were studied in a sleep lab on a single night with the auto - titrating EPAP that adjusts to abolish tidal EFL. The primary endpoint was to evaluate the behavior of the EPAP during the night. Additionally, a sub-group of patients used the device at home for a 2 week period. EPAP behavior was assessed during this 2 week period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 26, 2021
Enrollment StartOct 4, 2018
Primary CompletionMar 3, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.4 years ago

Interventions

Auto-Titrating EPAPdevice

In the Auto-titrating EPAP mode, the device automatically adjusted EPAP to the minimum level able to abolish tidal expiratory flow limitation.