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

University of Florida

Status: Terminated

Conditions: Cystic Fibrosis

Treatments: Device: Portable Internal Airway Percussion device; Device: Standard Airway Clearance device

Study type: Interventional

Funder types: Other

Identifiers

NCT04743206

OCR39724 (Other Identifier)

IRB201902662

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 6 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

PIAPD-Portable Internal Airway Percussion device

Experimental group

Description:

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

Treatment:

Device: Portable Internal Airway Percussion device

SACD-Standard Airway Clearance device

Active Comparator group

Description:

There will be an Outpatient Arm using the SACD, VEST (High Frequency Chest Wall Oscillation VEST) Standard Airway Clearance Device.

Treatment:

Device: Standard Airway Clearance device