Vibratory PEP Device and Hospital Length of Stay for Acute Exacerbation of COPD
Completed · Not applicable · Has a placebo group
Conditions studied: Chronic Obstructive Pulmonary Disease
In brief
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.
Key facts
- Study ID
- NCT03094806
- Run by
- New York Presbyterian Brooklyn Methodist Hospital
- People needed
- 91
- Starts
- 2013-10-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2024-03-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- New York Methodist Hospital — Brooklyn, New York, United States
Full record on ClinicalTrials.gov
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