Trial Outcomes & Findings for Study Assessing High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations (NCT NCT00739310)
NCT ID: NCT00739310
Last Updated: 2017-08-07
Results Overview
Hospitalizations lasting at least 24 hours
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
end of study
Results posted on
2017-08-07
Participant Flow
Participant milestones
| Measure |
Vest Treatment (HFCWO)
Patients will receive Vest treatments for airway clearance therapy 2 x daily
Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Vest Treatment (HFCWO)
Patients will receive Vest treatments for airway clearance therapy 2 x daily
Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes
|
|---|---|
|
Overall Study
Poor adherance to prescribed therapy
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Study Assessing High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations
Baseline characteristics by cohort
| Measure |
Vest Treatment (HFCWO)
n=22 Participants
Patients will receive Vest treatments for airway clearance therapy 2 x daily for 12 months. These data will be compared to 12 months of data prior to Vest initiation.
Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes
|
|---|---|
|
Age, Continuous
|
9.55 years
STANDARD_DEVIATION 5.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: end of studyHospitalizations lasting at least 24 hours
Outcome measures
| Measure |
Pre-Treatment
n=22 Participants
Prior to Vest Treatment
|
Post Vest Treatment
n=22 Participants
12 months of intervention 2 x daily Vest Therapy
|
|---|---|---|
|
Hospitalizations Lasting at Least 24 Hours in This Patient Population
|
10 hospitalizations
|
8 hospitalizations
|
Adverse Events
Vest Treatment (HFCWO)
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
Kathryn Fitzgerald, NP
Maimonides, Department of Pulmonary Medicine
Phone: 718-283-7339
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place