Pilot Study of Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis
Overview
- Phase
- Not Applicable
- Intervention
- Volara System
- Conditions
- Cystic Fibrosis
- Sponsor
- Daniel J. Weiner
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Sufficient sputum quantity for a pellet
- Status
- Completed
- Last Updated
- 3 days ago
Overview
Brief Summary
This is a small pilot study with the goal of identifying a superior sputum collection method in Cystic Fibrosis patients unable to produce a sputum.
Participants will use the Volara System during clinic visit in an attempt to produce sputum.
Detailed Description
Since the introduction of CFTR modulator therapies, most patients with Cystic Fibrosis (CF) have been unable to produce an adequate sputum sample for clinical monitoring. COVID-19 also presented a safety concern for staff and patients that may become exposed during sputum induction performed in the clinic rooms due to lack of negative pressure rooms and especially for patients who were unvaccinated. These issues led to lack of microbiology data for clinical care. The purpose of this project is to identify a superior sputum collection method for those patients unable to produce a sputum to guide future antimicrobial management.
Investigators
Daniel J. Weiner
Professor of Pediatrics and Pediatric Pulmonologist
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •18 years or older
- •2\. Currently prescribed hypertonic saline treatment as part of routine airway clearance therapy.
- •2\. No sputum culture results in last one year or those who were unable to produce sputum from VPEP method used in QI project 3771
Exclusion Criteria
- •\< 18 years old
- •Sputum culture results in last one year
Arms & Interventions
Intrapulmonary Percussive Ventilation for Non-sputum Producer
Unable to produce adequate amount of lower airway bacterial sampling for culture results in last year.
Intervention: Volara System
Outcomes
Primary Outcomes
Sufficient sputum quantity for a pellet
Time Frame: 10 minutes
Percentage of patients with a successful culture result from sputum
Sufficient Sputum Quantity for a Pellet
Time Frame: 10 minutes
Percentage of patients with a successful culture result from sputum