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

New York Presbyterian Brooklyn Methodist Hospital

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: Sham Acapella Vibratory PEP Device plus usual care; Device: Acapella Vibratory PEP Therapy Device plus usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT03094806

470455

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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91 participants in 2 patient groups, including a placebo group

Acapella Vibratory PEP Therapy Device

Experimental group

Description:

Subject will use the device 3 times a day throughout hospital stay

Treatment:

Device: Acapella Vibratory PEP Therapy Device plus usual care

Sham Acapella Vibratory PEP Device

Placebo Comparator group

Description:

Subject will use the sham device 3 times a day throughout hospital stay

Treatment:

Device: Sham Acapella Vibratory PEP Device plus usual care