Short-term Effects of Physiotherapy on LCI

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Device: PEP-MASK

• Registration Number: NCT03760120
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

Study Timeline

• Study Start: 2016-11-21
• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-30
• Primary Completion: 2022-08
• Status Verified: 2022-12
• Study Completion: 2022-12
• Last Update Submitted: 2022-12-28
• Last Update Posted: 2022-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PEP standard	PEP-MASK	-
PEP sham	PEP-MASK	-

Primary Outcome Measures

Name	Time	Method
Effect of PEP-MASK on ventilation heterogeneity (Sacin)	Right after intervention/sham procedure	Acinar airways (Sacin) mean difference between treatments

Secondary Outcome Measures

Name	Time	Method
Sputum weight	From the beginning to the end of each intervention/sham procedure	Sputum weight (grams) will be collected throughout the active or sham interventions
Oxygen saturation	From the beginning to the end of each intervention/sham procedure	Oxygen saturation (SpO2) will be monitored throughout the active or sham interventions
Effect of PEP-MASK on ventilation heterogeneity (Scond)	Right after intervention/sham procedure	Conductive airways (Scond) mean difference between treatments
Effect of PEP-MASK on ventilation heterogeneity (LCI)	Right after intervention/sham procedure	Ventilation heterogeneity (LCI) mean difference between treatments

Trial Locations

Locations (2)

Centro Regionale di Riferimento Fibrosi Cistica; 🇮🇹 Milano, Italy

Azienda Ospedaliero-Universitaria Meyer; 🇮🇹 Firenze, Italy