N/A
N=91
Vibratory PEP Device and Hospital Length of Stay for Acute Exacerbation of COPD
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT03094806 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Length of Stay — 4.8; 3.2 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acapella Vibratory PEP Therapy Device plus usual care (Device); Sham Acapella Vibratory PEP Device plus usual care (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York Presbyterian Brooklyn Methodist Hospital
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Stay |
4.8; 3.2 | — |
| SECONDARY Analysis of Change in Daily Sputum Production |
6.6; 14.6; 7.5; 15.9; 6.5; 15.9 | — |
| SECONDARY Dyspnea on the Borg Scale |
5.0; 5.1; 3.7; 4.3; 3.3; 3.3 | — |
| SECONDARY Dyspnea on the MMRC Scale |
2.2; 2.4; 1.9; 2.1; 1.7; 2.2 | — |
| SECONDARY Change in 6MWT Test |
168.8; 206.7; 200.1; 199.3 | — |
| SECONDARY Difference in Bedside Spirometry |
70.7; 57.7 | — |
| SECONDARY In Hospital Mortality |
0; 0 | — |
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.
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) 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.
Data sourced from ClinicalTrials.gov (NCT03094806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.