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

NCT04743206 | Terminated Results FDA Device

• 2 other identifiers: IRB201902662OCR39724
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Airway Clearance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

PIAPD-Portable Internal Airway Percussion device

EXPERIMENTAL

There will be an outpatient arm using the PIAPD-Portable Internal Airway Percussion Device.

Device: Portable Internal Airway Percussion device

SACD-Standard Airway Clearance device

ACTIVE COMPARATOR

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

Interventions

Standard Airway Clearance device DEVICE

Subjects will be using their home standard airway clearance device, VEST (High Frequency Chest Wall Oscillation VEST) for 2 weeks followed by PIAPD.

SACD-Standard Airway Clearance device

Portable Internal Airway Percussion device DEVICE

Subjects will be using the investigational device, PIAPD (Portable Internal Airway Percussion Device) for 2 weeks.

PIAPD-Portable Internal Airway Percussion device

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Medical Plaza Pulmonary Clinic

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Results Point of Contact

• Title: Silvia Delgado Villalta
• Organization: University of Florida

silviadelgado@ufl.edu

7185684198

Study Officials

• Silvia Delgado Villalta, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: May 18, 2021
• Primary Completion: July 31, 2021
• Study Completion: August 1, 2021
• Last Updated: November 19, 2024
• Results First Posted: November 19, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)