Vibratory PEP Device and Hospital Length of Stay for Acute Exacerbation of COPD

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

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 Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: Acapella Vibratory PEP Therapy Device plus usual care; Device: Sham Acapella Vibratory PEP Device plus usual care

Detailed Description

The investigators hypothesize that the PEP-FV used as adjunctive therapy in patients hospitalized for an acute exacerbation of COPD will result in decreased hospital length of stay and improvement of overall COPD-related health outcomes.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11215
      • New York Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Admitted with COPD exacerbation as a primary diagnosis
• Subjectively produces more than 1 tablespoon (15 ml) / day of sputum
• Has the subjective feeling that he/she cannot cough up or clear her secretions
• Physical respiratory system exam by the physician with evidence of course ronchi suggestive of impacted secretions
• > 10 pack-year smoking history

Exclusion Criteria:

• Cannot use the flutter device or unable to follow commands
• Altered mental status
• Known active malignancy
• Known systolic congestive heart failure (CHF) with ejection fraction (EF) < 40% or clinically in acute CHF exacerbation as documented by cardiologist or primary diagnosis other than COPD
• Pregnancy
• Patients in severe exacerbation (Intubated, Continuous use of NIPPV, Unable to speak full sentences)
• Intracranial pressure (ICP) >20 mmHg
• Hemodynamic instability (requiring vasopressor support)
• Recent facial, oral, or skull surgery or trauma.
• Acute sinusitis.
• Epistaxis.
• Esophageal surgery.
• Active Hemoptysis (More than 2 tablespoons of frank blood per day)
• Nausea.
• Severe earache or discharge from ear. (Known or suspected tympanic membrane rupture or other middle ear pathology)
• Untreated pneumothorax.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acapella Vibratory PEP Therapy Device; Subject will use the device 3 times a day throughout hospital stay	Device: Acapella Vibratory PEP Therapy Device plus usual care; 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.
Placebo Comparator: Sham Acapella Vibratory PEP Device; Subject will use the sham device 3 times a day throughout hospital stay	Device: Sham Acapella Vibratory PEP Device plus usual care; The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	Time of admission to time of discharge from hospital	Up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of Change in Daily Sputum Production	Sputum production in a 24 hour period in mL volume	Up to 5 days
Dyspnea on the Borg Scale	Scale is used to rate the difficulty of breathing. It starts at 0 where the breathing is causing no difficulty at all and progresses through to number 10 where the breathing difficulty is maximal.	Up to 5 days
Dyspnea on the MMRC Scale	The Modified Medical Research Council (MMRC) dyspnea scale is used to assess an individual's shortness of breath. It starts at 0 where the shortness of breath occurs during strenuous exercise and progresses through to number 4 where the shortness of breath is maximal.	Up to 5 days
Change in 6MWT Test	A six-minute walk test (6MWT) measures the distance that an individual can walk on a flat, hard surface in a period of six minutes. This is used to assess the exercise tolerance measured by the difference in meters between the tests.	Day 1 and Day 5
Difference in Bedside Spirometry	Degree of airflow obstruction (FEV1/FVC)	Day 5
In Hospital Mortality	Death at the time of discharge	Up to 2 weeks

Collaborators and Investigators

• Sponsor: New York Presbyterian Brooklyn Methodist Hospital
• Investigators: Principal Investigator: Jeremy A Weingarten, MD, New York Presbyterian Brooklyn Methodist Hospital

Publications and helpful links

General Publications

• Milan S, Bondalapati P, Megally M, Patel E, Vaghasia P, Gross L, Bachman EM, Chadha P, Weingarten JA. Positive Expiratory Pressure Therapy With And Without Oscillation And Hospital Length Of Stay For Acute Exacerbation Of Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2019 Nov 20;14:2553-2561. doi: 10.2147/COPD.S213546. eCollection 2019.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 470455