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

Not Applicable
Completed
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
Device: Acapella Vibratory PEP Therapy Device plus usual care
Device: Sham Acapella Vibratory PEP Device plus usual care
Registration Number
NCT03094806
Lead Sponsor
New York Presbyterian Brooklyn Methodist Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
91
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Acapella Vibratory PEP Therapy DeviceAcapella Vibratory PEP Therapy Device plus usual careSubject will use the device 3 times a day throughout hospital stay
Sham Acapella Vibratory PEP DeviceSham Acapella Vibratory PEP Device plus usual careSubject will use the sham device 3 times a day throughout hospital stay
Primary Outcome Measures
NameTimeMethod
Length of StayUp to 2 weeks

Time of admission to time of discharge from hospital

Secondary Outcome Measures
NameTimeMethod
Difference in Bedside SpirometryDay 5

Degree of airflow obstruction (FEV1/FVC)

Analysis of Change in Daily Sputum ProductionUp to 5 days

Sputum production in a 24 hour period in mL volume

Dyspnea on the Borg ScaleUp 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.

Dyspnea on the MMRC ScaleUp 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.

In Hospital MortalityUp to 2 weeks

Death at the time of discharge

Change in 6MWT TestDay 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.

Trial Locations

Locations (1)

New York Methodist Hospital

🇺🇸

Brooklyn, New York, United States

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