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Completed

NCT Number: NCT03094806

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acapella Vibratory PEP Therapy Device plus usual care

Device

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

Device

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

Primary outcomes

  1. Length of Stay

    Time frame: Up to 2 weeks

    Time of admission to time of discharge from hospital

Secondary outcomes

  1. Analysis of Change in Daily Sputum Production

    Time frame: Up to 5 days

    Sputum production in a 24 hour period in mL volume

  2. Dyspnea on the Borg Scale

    Time frame: Up to 5 days

    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.

  3. Dyspnea on the MMRC Scale

    Time frame: Up to 5 days

    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.

  4. Change in 6MWT Test

    Time frame: Day 1 and Day 5

    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.

  5. Difference in Bedside Spirometry

    Time frame: Day 5

    Degree of airflow obstruction (FEV1/FVC)

  6. In Hospital Mortality

    Time frame: Up to 2 weeks

    Death at the time of discharge

Sponsors and collaborators

Lead sponsor

New York Presbyterian Brooklyn Methodist Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 29, 2017
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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