NCT03094806CompletedNot Applicable
Vibratory/Positive Expiratory Pressure Device and Hospital Length of Stay for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
New York Presbyterian Brooklyn Methodist Hospital2 sites in 1 country91 target enrollmentStarted: October 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 91
- Locations
- 2
- Primary Endpoint
- Length of Stay
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •Severe earache or discharge from ear. (Known or suspected tympanic membrane rupture or other middle ear pathology)
- •Untreated pneumothorax.
Outcomes
Primary Outcomes
Length of Stay
Time Frame: Up to 2 weeks
Time of admission to time of discharge from hospital
Secondary Outcomes
- Analysis of Change in Daily Sputum Production(Up to 5 days)
- Dyspnea on the Borg Scale(Up to 5 days)
- Dyspnea on the MMRC Scale(Up to 5 days)
- In Hospital Mortality(Up to 2 weeks)
- Change in 6MWT Test(Day 1 and Day 5)
- Difference in Bedside Spirometry(Day 5)
Investigators
Jeremy Weingarten, MD
Dr
New York Presbyterian Brooklyn Methodist Hospital
Study Sites (2)
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