Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Device: Volara System

• Registration Number: NCT06311292
• Lead Sponsor: Daniel J. Weiner

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.

Study Timeline

• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-15
• Study Start: 2024-05-29
• Status Verified: 2025-02
• Primary Completion: 2025-03-19
• Study Completion: 2025-03-19
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. 18 years or older

2. 2. Currently prescribed hypertonic saline treatment as part of routine airway clearance therapy.

3. 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

1. < 18 years old
2. Sputum culture results in last one year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intrapulmonary Percussive Ventilation for Non-sputum Producer	Volara System	Unable to produce adequate amount of lower airway bacterial sampling for culture results in last year.

Primary Outcome Measures

Name	Time	Method
Sufficient sputum quantity for a pellet	10 minutes	Percentage of patients with a successful culture result from sputum

Trial Locations

Locations (1)

UPMC Presbyterian Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States