Vibratory PEP Device and Hospital Length of Stay for Acute Exacerbation of COPD
NCT ID: NCT03094806
Last Updated: 2024-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
91 participants
INTERVENTIONAL
2013-10-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Acapella Vibratory PEP Therapy Device
Subject will use the device 3 times a day throughout hospital stay
Acapella Vibratory PEP Therapy Device plus usual care
The acapella® Vibratory PEP Therapy System (PEP-FV) device is a handheld device that operates in same principle as standard FV. Unlike standard FV, it is not gravity dependent. It comes in two different devices to accommodate for different flows rates of the patient. It has similar properties of a standard FV and may be better tolerated.
Sham Acapella Vibratory PEP Device
Subject will use the sham device 3 times a day throughout hospital stay
Sham Acapella Vibratory PEP Device plus usual care
The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device.
Interventions
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Acapella Vibratory PEP Therapy Device plus usual care
The acapella® Vibratory PEP Therapy System (PEP-FV) device is a handheld device that operates in same principle as standard FV. Unlike standard FV, it is not gravity dependent. It comes in two different devices to accommodate for different flows rates of the patient. It has similar properties of a standard FV and may be better tolerated.
Sham Acapella Vibratory PEP Device plus usual care
The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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New York Presbyterian Brooklyn Methodist Hospital
OTHER
Responsible Party
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Jeremy Weingarten, MD
Dr
Principal Investigators
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Jeremy A Weingarten, MD
Role: PRINCIPAL_INVESTIGATOR
New York Presbyterian Brooklyn Methodist Hospital
Locations
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New York Methodist Hospital
Brooklyn, New York, United States
Countries
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References
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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.
Other Identifiers
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470455
Identifier Type: -
Identifier Source: org_study_id
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