Trial Outcomes & Findings for Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device (NCT NCT04743206)
NCT ID: NCT04743206
Last Updated: 2024-11-19
Results Overview
oxygen saturation will be obtained by home pulse oximeter device.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome 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
Results posted on
2024-11-19
Participant Flow
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.
Participant milestones
| Measure |
SOC Airway Clearance Device (VEST) Followed by PIAPD-Portable Internal Airway Percussion Device
Subjects will use Standard of Care (SCA) airway clearance Device (VEST) for 2 weeks followed by Interventional Airway Clearance Device (PIAPD) for 2 weeks.
Forced Expiratory Volume in 1 Second (FEV1) will be measured by Smart One® portable home spirometer.
|
|---|---|
|
SOC Airway Clearance Device ( VEST)
STARTED
|
1
|
|
SOC Airway Clearance Device ( VEST)
COMPLETED
|
1
|
|
SOC Airway Clearance Device ( VEST)
NOT COMPLETED
|
0
|
|
PIAPD
STARTED
|
1
|
|
PIAPD
COMPLETED
|
1
|
|
PIAPD
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device
Baseline characteristics by cohort
| Measure |
SACD-Standard Airway Clearance Device Followed by PIAPD
n=1 Participants
There will be an Outpatient Arm using the SACD for 2 weeks followed by PIAPD for 2 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
PRIMARY outcome
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 2oxygen saturation will be obtained by home pulse oximeter device.
Outcome measures
| Measure |
SOC Airway Clearance Device (VEST) Followed by PIAPD-Portable Internal Airway Percussion Device
n=1 Participants
Subjects will use Standard of Care (SCA) airway clearance Device (VEST) for 2 weeks followed by Interventional Airway Clearance Device (PIAPD) for 2 weeks.
|
|---|---|
|
Oxygen Saturation % by Pulse Oximetry
week 1 Vest pretreatment
|
98 percentage of oxygen saturated hemoglobi
|
|
Oxygen Saturation % by Pulse Oximetry
week 1 Vest post treatment
|
98 percentage of oxygen saturated hemoglobi
|
|
Oxygen Saturation % by Pulse Oximetry
week 2 Vest pretreatment
|
97 percentage of oxygen saturated hemoglobi
|
|
Oxygen Saturation % by Pulse Oximetry
week 2 Vest post treatment
|
98 percentage of oxygen saturated hemoglobi
|
|
Oxygen Saturation % by Pulse Oximetry
week 1 PIAPD pretreatment
|
98 percentage of oxygen saturated hemoglobi
|
|
Oxygen Saturation % by Pulse Oximetry
week 1 PIAPD post treatment
|
98 percentage of oxygen saturated hemoglobi
|
|
Oxygen Saturation % by Pulse Oximetry
week 2 PIAPD pretreatment
|
99 percentage of oxygen saturated hemoglobi
|
|
Oxygen Saturation % by Pulse Oximetry
week 2 PIAPD post treatment
|
98 percentage of oxygen saturated hemoglobi
|
Adverse Events
Vest Followed by PIADD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place