Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis

Daniel J. Weiner

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Device: Volara System

Study type: Interventional

Funder types: Other

Identifiers

NCT06311292

STUDY22090138

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intrapulmonary Percussive Ventilation for Non-sputum Producer

Experimental group

Description:

Unable to produce adequate amount of lower airway bacterial sampling for culture results in last year.

Treatment:

Device: Volara System