Short-term Effects of Physiotherapy on LCI (SPICy)

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

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).

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Device: PEP-MASK

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Firenze, Italy
    • Azienda Ospedaliero-Universitaria Meyer
  • Milano, Italy
    • Centro Regionale di Riferimento Fibrosi Cistica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PEP standard	Device: PEP-MASK
Sham Comparator: PEP sham	Device: PEP-MASK

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Investigators: Study Director: Carla Colombo, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Publications and helpful links

General Publications

• 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.

Helpful Links

• Standard Operating Procedures LCI

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2016
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: November 7, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (Actual): November 30, 2018

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: physiotherapy; pulmonary function
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 2291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No