An interventional study of Standard Airway Clearance device and Portable Internal Airway Percussion device in Cystic Fibrosis, sponsored by University of Florida. Terminated at 1 site in United States. Open to participants aged 6 Years to 21 Years. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by University of Florida · Not applicable, Interventional, and Other
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 1 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Any condition that, in the opinion of the investigator, would interfere with the study conduct or the safety of the participant
There will be an outpatient arm using the PIAPD-Portable Internal Airway Percussion Device.
Device: Portable Internal Airway Percussion device
There will be an Outpatient Arm using the SACD, VEST (High Frequency Chest Wall Oscillation VEST) Standard Airway Clearance Device.
Device: 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.
Subjects will be using the investigational device, PIAPD (Portable Internal Airway Percussion Device) for 2 weeks.
Oxygen Saturation % by Pulse Oximetry
oxygen saturation will be obtained by home pulse oximeter device.
Time frame: 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
Only one patient was recruited to the study. The patient was outpatient. There were difficulties with recruitment related to COVID-19 pandemic, difficulties obtaining pulmonary function testing related to Covid-19 pandemic, limited staff.
| Milestone | SOC Airway Clearance Device (VEST) Followed by PIAPD-Portable Internal Airway Percussion Device |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
| Milestone | SOC Airway Clearance Device (VEST) Followed by PIAPD-Portable Internal Airway Percussion Device |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
oxygen saturation will be obtained by home pulse oximeter device.
| percentage of oxygen saturated hemoglobi | SOC Airway Clearance Device (VEST) Followed by PIAPD-Portable Internal Airway Percussion Device |
|---|---|
| week 1 Vest pretreatment | 98 |
| week 1 Vest post treatment | 98 |
| week 2 Vest pretreatment | 97 |
| week 2 Vest post treatment | 98 |
| week 1 PIAPD pretreatment | 98 |
| week 1 PIAPD post treatment | 98 |
| week 2 PIAPD pretreatment | 99 |
| week 2 PIAPD post treatment | 98 |
Collected over The collection time was between June 17, 2021 to June 26, 2021 - please clarify this is a 4 week study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vest Followed by PIADD | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
only one patient was recruited. The patient participated as outpatient.
| Age, Categorical(Participants) | SACD-Standard Airway Clearance Device Followed by PIAPD |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | SACD-Standard Airway Clearance Device Followed by PIAPD |
|---|---|
| Female | 1 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | SACD-Standard Airway Clearance Device Followed by PIAPD |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | SACD-Standard Airway Clearance Device Followed by PIAPD |
|---|---|
| United States | 1 |
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University of Florida