Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-29

Study Completion Date

2025-03-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

No parties will be prevented from having knowledge of the Volara System use.

Study Groups

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Intrapulmonary Percussive Ventilation for Non-sputum Producer

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

Group Type EXPERIMENTAL

Volara System

Intervention Type DEVICE

Intrapulmonary percussive ventilation for mobilizing mucus.

Interventions

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Volara System

Intrapulmonary percussive ventilation for mobilizing mucus.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 18 years or older
2. 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