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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04743206
• Other study ID #: IRB201902662
• Secondary ID: OCR39724
• Status: Completed
• Phase: N/A
• Start date: May 18, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 1, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• Standard Airway Clearance device
A large majority of our patients will be using VEST therapy as their standard of care airway clearance
• Portable Internal Airway Percussion device
Smart One® portable home spirometer

Locations

Country	Name	City	State
United States	UF Medical Plaza Pulmonary Clinic	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the number of cystic fibrosis patients perception of breathing effort and device use	The number of cystic fibrosis patients perception of their breathing effort and device use	14 days