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Clinical Trials/NCT03094806
NCT03094806
Completed
Not Applicable

Vibratory/Positive Expiratory Pressure Device and Hospital Length of Stay for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

New York Presbyterian Brooklyn Methodist Hospital1 site in 1 country91 target enrollmentOctober 2013
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ConditionsChronic Obstructive Pulmonary Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
New York Presbyterian Brooklyn Methodist Hospital
Enrollment
91
Locations
1
Primary Endpoint
Length of Stay
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
December 2015
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
New York Presbyterian Brooklyn Methodist Hospital
Responsible Party
Principal Investigator
Principal Investigator

Jeremy Weingarten, MD

Dr

New York Presbyterian Brooklyn Methodist Hospital

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) \< 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.

Outcomes

Primary Outcomes

Length of Stay

Time Frame: Up to 2 weeks

Time of admission to time of discharge from hospital

Secondary Outcomes

  • 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)
  • In Hospital Mortality(Up to 2 weeks)
  • Change in 6MWT Test(Day 1 and Day 5)
  • Difference in Bedside Spirometry(Day 5)

Study Sites (1)

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