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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-18

Study Completion Date

2021-08-01

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), 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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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PIAPD-Portable Internal Airway Percussion device

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

Group Type EXPERIMENTAL

Portable Internal Airway Percussion device

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Standard Airway Clearance device

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Portable Internal Airway Percussion device

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

Intervention Type DEVICE

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 -----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

Minimum Eligible Age

6 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No