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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094806
• Other study ID #: 470455
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2024
• Source: New York Presbyterian Brooklyn Methodist Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York Methodist Hospital	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Presbyterian Brooklyn Methodist Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Stay	Time of admission to time of discharge from hospital	Up to 2 weeks
Secondary	Analysis of Change in Daily Sputum Production	Sputum production in a 24 hour period in mL volume	Up to 5 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Difference in Bedside Spirometry	Degree of airflow obstruction (FEV1/FVC)	Day 5
Secondary	In Hospital Mortality	Death at the time of discharge	Up to 2 weeks