CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 91 enrolled
Drug / intervention
Acapella Vibratory PEP Therapy Device plus usual care +1 moredevice
Likely dose
Acapella Vibratory PEP Therapy Device used as adjunct to usual careAI-extracted
Key inclusion· 5
  • Admitted with COPD exacerbation as primary diagnosis
  • Produces >15 mL/day of sputum subjectively
  • Subjective difficulty clearing secretions
  • Physician exam with coarse ronchi suggesting impacted secretions
Key exclusion· 10
  • Cannot use flutter device or follow commands
  • Altered mental status
  • Active malignancy or non-COPD primary diagnosis
  • Severe exacerbation (intubated, continuous NIV, unable to speak full sentences)

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

Search/NCT03094806
NCT03094806N/ACompleted

Vibratory/Positive Expiratory Pressure Device and Hospital Length of Stay for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

New York Presbyterian Brooklyn Methodist Hospital·interventional·Posted Mar 29, 2017·Updated Mar 21, 2024

In Brief

A clinical study evaluating Acapella Vibratory PEP Therapy Device plus usual care and Sham Acapella Vibratory PEP Device plus usual care for Chronic Obstructive Pulmonary Disease. Completed, enrolled 91 participants across 1 site.

Detailed Summary

This study is evaluating the use of a respiratory device, the Acapella Vibratory Positive Expiratory Pressure (PEP) Therapy device, in patients admitted to the hospital with a chronic obstructive pulmonary disease (COPD) exacerbation.

Study Details

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

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 29, 2017
Enrollment StartOct 1, 2013
Primary CompletionOct 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 9.3 years ago

Interventions

Acapella Vibratory PEP Therapy Device plus usual caredevice

The acapella® Vibratory PEP Therapy System (PEP-FV) device is a handheld device that operates in same principle as standard FV. Unlike standard FV, it is not gravity dependent. It comes in two different devices to accommodate for different flows rates of the patient. It has similar properties of a standard FV and may be better tolerated.

Sham Acapella Vibratory PEP Device plus usual caredevice

The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device.