Short-term Effects of Physiotherapy on LCI

Cystic Fibrosis Clinical Trial

— SPICy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03760120
• Other study ID #: 2291
• Status: Completed
• Phase: N/A
• Start date: November 21, 2016
• Est. completion date: December 2022

Study information

• Verified date: December 2022
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• PEP-MASK

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Meyer	Firenze
Italy	Centro Regionale di Riferimento Fibrosi Cistica	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of PEP-MASK on ventilation heterogeneity (Sacin)	Acinar airways (Sacin) mean difference between treatments	Right after intervention/sham procedure
Secondary	Effect of PEP-MASK on ventilation heterogeneity (Scond)	Conductive airways (Scond) mean difference between treatments	Right after intervention/sham procedure
Secondary	Effect of PEP-MASK on ventilation heterogeneity (LCI)	Ventilation heterogeneity (LCI) mean difference between treatments	Right after intervention/sham procedure
Secondary	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
Secondary	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

External Links

•   Standard Operating Procedures LCI