NCT03760120

Short-term Effects of Physiotherapy on LCI

Short-term Effects of Positive Expiratory Pressure Mask on Ventilation Inhomogeneity in Children and Adolescents With Cystic Fibrosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DEVICE	PEP-MASK

Timeline

• Start date: 2016-11-21
• Primary completion: 2022-08-01
• Completion: 2022-12-01
• First posted: 2018-11-30
• Last updated: 2022-12-29

Locations

2 sites across 1 country: Italy