Status:
COMPLETED
Short-term Effects of Physiotherapy on LCI
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief Summary
Although some studies have brought some evidences about the efficacy of positive expiratory pressure (PEP)-mask therapy as an airway clearance technique, yet it is not clearly understood what is the c...
Detailed Description
Investigational device: PEP-MASK=Positive Expiratory Pressure delivered through a face mask. Standard Operating Procedures used for evaluating CF lung disease and ventilation inhomogeneity. Sample s...
Eligibility Criteria
Inclusion
- CF diagnosis
- Patients hospitalized for a scheduled intravenous antibiotics cycle and regularly followed-up by the CF Centre
- ≥ 15 kilograms
- FEV1 ≥ 40%predicted
- Ability to perform NMBW test
- Ability to perform spirometry
- Willing to adhere to protocol procedures
- Patients in treatment with PEP-MASK
Exclusion
- Pulmonary Exacerbation within two last week
- Burkholderia cepacia infection
- Patients in lung transplantation waiting list
- Patients undergoing non invasive mechanical ventilation or oxygen therapy
Key Trial Info
Start Date :
November 21 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03760120
Start Date
November 21 2016
End Date
December 1 2022
Last Update
December 29 2022
Active Locations (2)
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1
Azienda Ospedaliero-Universitaria Meyer
Florence, Italy
2
Centro Regionale di Riferimento Fibrosi Cistica
Milan, Italy