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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrapulmonary Percussive Ventilation for Non-sputum Producer | Experimental | Unable to produce adequate amount of lower airway bacterial sampling for culture results in last year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volara System | Device | Intrapulmonary percussive ventilation for mobilizing mucus. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sufficient Sputum Quantity for a Pellet | Percentage of patients with a successful culture result from sputum | 10 minutes |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Weiner, MD | UPMC Children's Hospital of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
The investigators do not currently have an individual participant data sharing plan. However, de-identified research data/documents may be shared in the future with other investigators who share similar research interests.
Specimens and data will not be released without (1) PI written permission and (2) appropriate Institutional Review Board (IRB) approval. Data use and/or material transfer agreements will also be required as applicable to outside researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intrapulmonary Percussive Ventilation for Non-sputum Producer | Unable to produce adequate amount of lower airway bacterial sampling for culture results in last year. Volara System: Intrapulmonary percussive ventilation for mobilizing mucus. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intrapulmonary Percussive Ventilation for Non-sputum Producer | Unable to produce adequate amount of lower airway bacterial sampling for culture results in last year. Volara System: Intrapulmonary percussive ventilation for mobilizing mucus. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sufficient Sputum Quantity for a Pellet | Percentage of patients with a successful culture result from sputum | Posted | Count of Participants | Participants | 10 minutes |
|
|
1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intrapulmonary Percussive Ventilation for Non-sputum Producer | Unable to produce adequate amount of lower airway bacterial sampling for culture results in last year. Volara System: Intrapulmonary percussive ventilation for mobilizing mucus. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Weiner | UPMC Children's Hospital of Pittsburgh | 412-692-5630 | daniel.weiner@chp.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2025 | Apr 8, 2026 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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No parties will be prevented from having knowledge of the Volara System use.
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |