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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acapella Vibratory PEP Therapy Device plus usual care
Sham Acapella Vibratory PEP Device plus usual care
Sponsored by
New York Presbyterian Brooklyn Methodist Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acapella Vibratory PEP Therapy Device

Sham Acapella Vibratory PEP Device

Arm Description

Subject will use the device 3 times a day throughout hospital stay

Subject will use the sham device 3 times a day throughout hospital stay

Outcomes

Primary Outcome Measures

Length of Stay
Time of admission to time of discharge from hospital

Secondary Outcome Measures

Analysis of Change in Daily Sputum Production
Sputum production in a 24 hour period in mL volume
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.
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.
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.
Difference in Bedside Spirometry
Degree of airflow obstruction (FEV1/FVC)
In Hospital Mortality
Death at the time of discharge

Full Information

First Posted
May 27, 2015
Last Updated
September 12, 2018
Sponsor
New York Presbyterian Brooklyn Methodist Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03094806
Brief Title
Vibratory PEP Device and Hospital Length of Stay for Acute Exacerbation of COPD
Official Title
Vibratory/Positive Expiratory Pressure Device and Hospital Length of Stay for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York Presbyterian Brooklyn Methodist Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acapella Vibratory PEP Therapy Device
Arm Type
Experimental
Arm Description
Subject will use the device 3 times a day throughout hospital stay
Arm Title
Sham Acapella Vibratory PEP Device
Arm Type
Placebo Comparator
Arm Description
Subject will use the sham device 3 times a day throughout hospital stay
Intervention Type
Device
Intervention Name(s)
Acapella Vibratory PEP Therapy Device plus usual care
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Acapella Vibratory PEP Device plus usual care
Intervention Description
The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device.
Primary Outcome Measure Information:
Title
Length of Stay
Description
Time of admission to time of discharge from hospital
Time Frame
Up to 2 weeks
Secondary Outcome Measure Information:
Title
Analysis of Change in Daily Sputum Production
Description
Sputum production in a 24 hour period in mL volume
Time Frame
Up to 5 days
Title
Dyspnea on the Borg Scale
Description
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.
Time Frame
Up to 5 days
Title
Dyspnea on the MMRC Scale
Description
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.
Time Frame
Up to 5 days
Title
Change in 6MWT Test
Description
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.
Time Frame
Day 1 and Day 5
Title
Difference in Bedside Spirometry
Description
Degree of airflow obstruction (FEV1/FVC)
Time Frame
Day 5
Title
In Hospital Mortality
Description
Death at the time of discharge
Time Frame
Up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy A Weingarten, MD
Organizational Affiliation
New York Presbyterian Brooklyn Methodist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31819393
Citation
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.
Results Reference
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Vibratory PEP Device and Hospital Length of Stay for Acute Exacerbation of COPD

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