Cystic Fibrosis
Conditions
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.
Interventions
DEVICEVolara System
Intrapulmonary percussive ventilation for mobilizing mucus.
Sponsors
Daniel J. Weiner
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
No parties will be prevented from having knowledge of the Volara System use.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
1. \< 18 years old 2. Sputum culture results in last one year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sufficient Sputum Quantity for a Pellet | 10 minutes | Percentage of patients with a successful culture result from sputum |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel Weiner, MD
UPMC Children's Hospital of Pittsburgh
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 20 years |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
None listed