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

Last updated: October 28, 2024
Sponsor: University of Florida
Overall Status: Terminated

Phase

N/A

Condition

Cystic Fibrosis

Lung Disease

Scar Tissue

Treatment

Portable Internal Airway Percussion device

Standard Airway Clearance device

Clinical Study ID

NCT04743206
IRB201902662
OCR39724
  • Ages 6-21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 cysticfibrosis

  • Participant (or parent or legal guardian if the participant is a minor) is willingto provide -----Informed Consent

Exclusion

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 thestudy conduct or the safety of the participant

  • Additional Exclusion Criteria: Outpatient Arm (in addition to general exclusioncriteria above) Decrease in FEV1 > 10% from baseline over last 12 monthsAntibiotic Initiation for acute CF exacerbation Hospitalization for CFExacerbation

  • Additional Exclusion Criteria: Inpatient Arm (in addition to general exclusioncriteria above) Failure to increase FEV1 > 10 % from initial Pulmonary functiontesting (PFTs) on admission by day 9 of hospitalization.

Study Design

Total Participants: 1
Treatment Group(s): 2
Primary Treatment: Portable Internal Airway Percussion device
Phase:
Study Start date:
May 18, 2021
Estimated Completion Date:
August 01, 2021

Connect with a study center

  • UF Medical Plaza Pulmonary Clinic

    Gainesville, Florida 32610
    United States

    Site Not Available

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