Cystic Fibrosis
Conditions
Keywords
Airway Clearance
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.
Interventions
DEVICEStandard 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.
DEVICEPortable Internal Airway Percussion device
Subjects will be using the investigational device, PIAPD (Portable Internal Airway Percussion Device) for 2 weeks.
Sponsors
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Saturation % by Pulse Oximetry | 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 | oxygen saturation will be obtained by home pulse oximeter device. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| SACD-Standard Airway Clearance Device Followed by PIAPD There will be an Outpatient Arm using the SACD for 2 weeks followed by PIAPD for 2 weeks. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | SACD-Standard Airway Clearance Device Followed by PIAPD |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOC Airway Clearance Device (VEST) Followed by PIAPD-Portable Internal Airway Percussion Device | Oxygen Saturation % by Pulse Oximetry | week 1 Vest pretreatment | 98 percentage of oxygen saturated hemoglobi |
| SOC Airway Clearance Device (VEST) Followed by PIAPD-Portable Internal Airway Percussion Device | Oxygen Saturation % by Pulse Oximetry | week 1 Vest post treatment | 98 percentage of oxygen saturated hemoglobi |
| SOC Airway Clearance Device (VEST) Followed by PIAPD-Portable Internal Airway Percussion Device | Oxygen Saturation % by Pulse Oximetry | week 2 Vest pretreatment | 97 percentage of oxygen saturated hemoglobi |
| SOC Airway Clearance Device (VEST) Followed by PIAPD-Portable Internal Airway Percussion Device | Oxygen Saturation % by Pulse Oximetry | week 2 Vest post treatment | 98 percentage of oxygen saturated hemoglobi |
| SOC Airway Clearance Device (VEST) Followed by PIAPD-Portable Internal Airway Percussion Device | Oxygen Saturation % by Pulse Oximetry | week 1 PIAPD pretreatment | 98 percentage of oxygen saturated hemoglobi |
| SOC Airway Clearance Device (VEST) Followed by PIAPD-Portable Internal Airway Percussion Device | Oxygen Saturation % by Pulse Oximetry | week 1 PIAPD post treatment | 98 percentage of oxygen saturated hemoglobi |
| SOC Airway Clearance Device (VEST) Followed by PIAPD-Portable Internal Airway Percussion Device | Oxygen Saturation % by Pulse Oximetry | week 2 PIAPD pretreatment | 99 percentage of oxygen saturated hemoglobi |
| SOC Airway Clearance Device (VEST) Followed by PIAPD-Portable Internal Airway Percussion Device | Oxygen Saturation % by Pulse Oximetry | week 2 PIAPD post treatment | 98 percentage of oxygen saturated hemoglobi |