Cystic Fibrosis Clinical Trial
Official title:
Intrapulmonary Percussive Ventilation vs Chest Physiotherapy Vest in Airway Clearance During Cystic Fibrosis Pulmonary Exacerbation
NCT number | NCT03261219 |
Other study ID # | IRB201700115 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2018 |
Est. completion date | October 30, 2018 |
Verified date | October 2018 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Intrapulmonary Percussive Ventilation (IPV) will show greater improvements in Forced
Expiatory Volume in 1 second (FEV1) shorter duration of stay, and greater time to next
pulmonary exacerbation in pediatric Cystic Fibrosis patients admitted for pulmonary
exacerbation.
FEV1 is a measurement of obstruction in the airway which is seen to be elevated in CF
patients with worsening lung disease. FEV1 is used as a primary endpoint in pulmonary trials
because it is an acute indicator of worsening or improving lung function.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 30, 2018 |
Est. primary completion date | August 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 21 Years |
Eligibility |
Inclusion Criteria: - CF patient admitted for pulmonary exacerbation Exclusion Criteria: - Patients who are not able to perform spirometry, patients with neurological impairment (Cerebral Palsy) or severe behavioral problems that precludes consistent use of IPV, patients with pneumothorax or significant hemoptysis, patients who require supplemental oxygen or ventilatory support, or patients whose parents/guardians are not willing to consent will be excluded. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FEV1 change | change in FEV1 from baseline at admission | duration of hospital stay (usually 10-14 days) | |
Secondary | time to next admission | time in days to next hospital admission for CF Pulmonary Exacerbation | from discharge to 6 months after discharge | |
Secondary | Patient Satisfaction with airway clearance modality | survey of satisfaction with prescribed airway clearance modality | 10 minutes after each discharge during study period | |
Secondary | Length of admission | length of admission in days | usually 10-14 days |
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