Clinical trial NCT03094806: Vibratory PEP Device and Hospital Length of Stay for Acute Exacerbation of COPD
Official title: Vibratory/Positive Expiratory Pressure Device and Hospital Length of Stay for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: New York Presbyterian Brooklyn Methodist Hospital
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Length of Stay
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Analysis of Change in Daily Sputum Production
timeFrame: Up to 5 days
measure: Dyspnea on the Borg Scale
timeFrame: Up to 5 days
measure: Dyspnea on the MMRC Scale
timeFrame: Up to 5 days
measure: Change in 6MWT Test
timeFrame: Day 1 and Day 5
measure: Difference in Bedside Spirometry
timeFrame: Day 5
measure: In Hospital Mortality
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
Study officials:
affiliation: New York Presbyterian Brooklyn Methodist Hospital
name: Jeremy A Weingarten, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milan S, Bondalapati P, Megally M, Patel E, Vaghasia P, Gross L, Bachman EM, Chadha P, Weingarten JA. Positive Expiratory Pressure Therapy With And Without Oscillation And Hospital Length Of Stay For Acute Exacerbation Of Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2019 Nov 20;14:2553-2561. doi: 10.2147/COPD.S213546. eCollection 2019.