Clinical trial NCT04743206: Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device
Official title: Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device (PIAPD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Airway Clearance
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 1
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Oxygen Saturation % by Pulse Oximetry
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Medical Plaza Pulmonary Clinic
state: Florida
Study officials:
affiliation: University of Florida
name: Silvia Delgado Villalta, MD
role: PRINCIPAL_INVESTIGATOR
References: