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

NCT03094806 | Completed Results

• 1 other identifier: 470455
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Length of Stay

  Time of admission to time of discharge from hospital

  Up to 2 weeks

Secondary Outcomes (6)

• Analysis of Change in Daily Sputum Production

  Up to 5 days

• Dyspnea on the Borg Scale

  Up to 5 days

• Dyspnea on the MMRC Scale

  Up to 5 days

• Change in 6MWT Test

  Day 1 and Day 5

• Difference in Bedside Spirometry

  Day 5

Study Arms (2)

Acapella Vibratory PEP Therapy Device

EXPERIMENTAL

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

Device: Acapella Vibratory PEP Therapy Device plus usual care

Sham Acapella Vibratory PEP Device

PLACEBO COMPARATOR

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

Device: Sham Acapella Vibratory PEP Device plus usual care

Interventions

Acapella Vibratory PEP Therapy Device plus usual care DEVICE

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.

Acapella Vibratory PEP Therapy Device

Sham Acapella Vibratory PEP Device plus usual care DEVICE

The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device.

Sham Acapella Vibratory PEP Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• New York Presbyterian Brooklyn Methodist Hospital: lead

Study Sites (1)

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Related Publications (1)

• 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.

  PMID: 31819393 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jeremy A Weingarten, MD
• Organization: New York Methodist Hospital

jaw9031@nyp.org

718-780-5835

Study Officials

• Jeremy A Weingarten, MD

  New York Presbyterian Brooklyn Methodist Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: March 29, 2017
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 21, 2024
• Results First Posted: October 11, 2018

Record last verified: 2024-03

Locations

US (1)