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NCT Number: NCT03760120

Short-term Effects of Physiotherapy on LCI

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).

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero-Universitaria Meyer, Florence, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEP-MASK

Device

Primary outcomes

  1. Effect of PEP-MASK on ventilation heterogeneity (Sacin)

    Time frame: Right after intervention/sham procedure

    Acinar airways (Sacin) mean difference between treatments

Secondary outcomes

  1. Effect of PEP-MASK on ventilation heterogeneity (Scond)

    Time frame: Right after intervention/sham procedure

    Conductive airways (Scond) mean difference between treatments

  2. Effect of PEP-MASK on ventilation heterogeneity (LCI)

    Time frame: Right after intervention/sham procedure

    Ventilation heterogeneity (LCI) mean difference between treatments

  3. Sputum weight

    Time frame: From the beginning to the end of each intervention/sham procedure

    Sputum weight (grams) will be collected throughout the active or sham interventions

  4. Oxygen saturation

    Time frame: From the beginning to the end of each intervention/sham procedure

    Oxygen saturation (SpO2) will be monitored throughout the active or sham interventions

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

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

Acronym: SPICy

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Nov 30, 2018
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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