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)

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.

Study Overview

• Status: Terminated
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Device: Portable Internal Airway Percussion device; Device: Standard Airway Clearance device

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Medical Plaza Pulmonary Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PIAPD-Portable Internal Airway Percussion device; There will be an outpatient arm using the PIAPD-Portable Internal Airway Percussion Device.	Device: Portable Internal Airway Percussion device; Subjects will be using the investigational device, PIAPD (Portable Internal Airway Percussion Device) for 2 weeks.
Active Comparator: SACD-Standard Airway Clearance device; There will be an Outpatient Arm using the SACD, VEST (High Frequency Chest Wall Oscillation VEST) Standard Airway Clearance Device.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Saturation % by Pulse Oximetry	oxygen saturation will be obtained by home pulse oximeter device.	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

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Silvia Delgado Villalta, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2021
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Airway Clearance
• Additional Relevant MeSH Terms: Pathologic Processes; Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: IRB201902662; OCR39724 (Other Identifier: UF Oncore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes