Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device

Study Overview
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Brief Summary
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This is a pilot study where the investigators aim to compare initial use of the standard airway clearance device (SACD) with subsequent use of a Portable Intra-Pulmonary Percussion Device (PIAPD) in patients with cystic fibrosis ages 6 -21 years. The primary hypothesis is that there is no effect of PIAPD on FEV1 2 hours after use, there is no effect on perception of effort and efficacy for the PIAPD. If both are equally effective, the latter device provides an alternative that is both cheaper and portable.

Official Title
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Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device (PIAPD)

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Device: Standard Airway Clearance device
* Device: Portable Internal Airway Percussion device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 6-21 years Cystic fibrosis stable by physician assessment Assents to forego additional experimental treatments during the study Currently using and familiar with airway clearance therapy for treatment of cystic fibrosis Participant (or parent or legal guardian if the participant is a minor) is willing to provide -----InformedConsent Exclusion Criteria: FEV1 < 40% predictive Pneumothorax Hemoptysis COVID-19 diagnosis within last 14 days Any condition that, in the opinion of the investigator, would interfere with the study conduct or the safety of the participant Additional Exclusion Criteria: Outpatient Arm (in addition to general exclusion criteria above) Decrease in FEV1 > 10% from baseline over last 12 months Antibiotic Initiation for acute CF exacerbation Hospitalization for CF Exacerbation Additional Exclusion Criteria: Inpatient Arm (in addition to general exclusion criteria above) Failure to increase FEV1 > 10 % from initial PFTs on admission by day 9 of hospitalization.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a pilot study where the investigators aim to compare initial use of the standard airway clearance device (SACD) with subsequent use of a PIAPD in patients with stable cystic fibrosis ages 6 -21 years. The primary hypothesis (Stated as Null) being that there is no effect of PIAPD on FEV1 2 hours after use, there is no effect on perception of effort and efficacy for the PIAPD.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PIAPD-Portable Internal Airway Percussion device<br>There will be an Inpatient Arm and Outpatient Arm using the Smart One® portable home spirometer | Device: Portable Internal Airway Percussion device<br>* Smart One® portable home spirometer<br>|
| Active Comparator: SACD-Standard Airway Clearance device<br>There will be an Inpatient Arm and Outpatient Arm using the SACD. A large majority of patients will be using VEST therapy as their standard of care airway clearance. A few might be using an Intrapulmonary Percussion Device that uses a mechanism different from the device the study will be testing. | Device: Standard Airway Clearance device<br>* A large majority of our patients will be using VEST therapy as their standard of care airway clearance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the number of cystic fibrosis patients perception of breathing effort and device use | The number of cystic fibrosis patients perception of their breathing effort and device use | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway Clearance