Clinical trial NCT03760120: Short-term Effects of Physiotherapy on LCI
Official title: Short-term Effects of Positive Expiratory Pressure Mask on Ventilation Inhomogeneity in Children and Adolescents With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: physiotherapy
pulmonary function
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 19
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross-over randomized controlled trial. Procedure: two nitrogen multiple-breath washout tests, one before and one after the intervention with PEP-Mask, either standard or sham allocation, during two subsequent mornings.
Primary purpose: TREATMENT

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 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).

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 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.

Eligibility criteria: 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:

* Pulmonary Exacerbation within two last week
* Burkholderia cepacia infection
* Patients in lung transplantation waiting list
* Patients undergoing non invasive mechanical ventilation or oxygen therapy

Primary outcomes:
measure: Effect of PEP-MASK on ventilation heterogeneity (Sacin)
timeFrame: Right after intervention/sham procedure
Secondary outcomes:
measure: Effect of PEP-MASK on ventilation heterogeneity (Scond)
timeFrame: Right after intervention/sham procedure
measure: Effect of PEP-MASK on ventilation heterogeneity (LCI)
timeFrame: Right after intervention/sham procedure
measure: Sputum weight
timeFrame: From the beginning to the end of each intervention/sham procedure
measure: Oxygen saturation
timeFrame: From the beginning to the end of each intervention/sham procedure
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Meyer
city: Milano
country: Italy
facility: Centro Regionale di Riferimento Fibrosi Cistica
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Carla Colombo
role: STUDY_DIRECTOR
References:
citation: Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.