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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
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
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

New York Methodist Hospital
🇺🇸Brooklyn, New York, United States

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