NCT04743206

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 6 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DEVICE	Standard Airway Clearance device	Subjects will be using their home standard airway clearance device, VEST (High Frequency Chest Wall Oscillation VEST) for 2 weeks followed by PIAPD.
DEVICE	Portable Internal Airway Percussion device	Subjects will be using the investigational device, PIAPD (Portable Internal Airway Percussion Device) for 2 weeks.

Timeline

• Start date: 2021-05-18
• Primary completion: 2021-07-31
• Completion: 2021-08-01
• First posted: 2021-02-08
• Last updated: 2024-11-19
• Results posted: 2024-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study