Short-term Effects of Physiotherapy on LCI (SPICy)

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Completed

Conditions

Cystic Fibrosis

Treatments

Device: PEP-MASK

Study type

Interventional

Funder types

Other

Identifiers

NCT03760120

2291

Details and patient eligibility

About

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 contribution of this technique in modifying peripheral ventilation inhomogeneity, a typical feature of patients with Cystic Fibrosis (CF).

The aim of this study is to investigate how PEP-MASK affects ventilation inhomogeneity in children and adolescents, with moderate to normal CF lung disease by the change in acinar airways (Sacin), lung clearance index (LCI) and conductive airways (Scond) indexes derived from nitrogen multiple-breath washout test (N2MBW).

Full 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 size: Based on preliminary data collected on seven subjects who performed nitrogen multiple-breath washout test before and after PEP-MASK, assuming a variation of 20% of Sacin, the study requires a sample size of 18 subjects.

Enrollment

19 patients

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria