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

Not Applicable

Terminated

Interventions: Device: Standard Airway Clearance device
Device: Portable Internal Airway Percussion device

Brief Summary: This is a pilot study where the investigators aim to compare initial use of the standard airway clearance device (SACD), most commonly used being High frequency vest airway clearance system (VEST) with subsequent use of a Portable Intra-Pulmonary Percussion Device (PIAPD) in patients with cystic fibrosis (CF) ages 6 -21 years. The primary hypothesis is that there is no effect of PIAPD on Forced expiratory volume in 1 second (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.

Recruitment & Eligibility

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 -----Informed Consent

Exclusion Criteria

FEV1 < 40% predictive
Pneumothorax
Hemoptysis
Coronavirus disease (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 Pulmonary function testing (PFTs) on admission by day 9 of hospitalization.

Arm && Interventions

Group	Intervention	Description
SACD-Standard Airway Clearance device	Standard Airway Clearance device	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.
PIAPD-Portable Internal Airway Percussion device	Portable Internal Airway Percussion device	There will be an Inpatient Arm and Outpatient Arm using the Smart One® portable home spirometer

Primary Outcome Measures

Name	Time	Method
Oxygen Saturation % by Pulse Oximetry	O2 saturation measured immediately prior to treatment and 2 hours after treatment - one-time pre/post treatment in week 1; and one-time pre/post treatment in week 2	oxygen saturation will be obtained by home pulse oximeter device.

Secondary Outcome Measures