Short-term Effects of Physiotherapy on LCI

NCT03760120 | Completed

• 1 other identifier: 2291
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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).

Conditions

Cystic Fibrosis

Keywords

physiotherapy; pulmonary function

Outcome Measures

Primary Outcomes (1)

• Effect of PEP-MASK on ventilation heterogeneity (Sacin)

  Acinar airways (Sacin) mean difference between treatments

  Right after intervention/sham procedure

Secondary Outcomes (4)

• Effect of PEP-MASK on ventilation heterogeneity (Scond)

  Right after intervention/sham procedure

• Effect of PEP-MASK on ventilation heterogeneity (LCI)

  Right after intervention/sham procedure

• Sputum weight

  From the beginning to the end of each intervention/sham procedure

• Oxygen saturation

  From the beginning to the end of each intervention/sham procedure

Study Arms (2)

PEP standard

ACTIVE COMPARATOR

Device: PEP-MASK

PEP sham

SHAM COMPARATOR

Device: PEP-MASK

Interventions

PEP-MASK DEVICE

PEP sham; PEP standard

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pulmonary Exacerbation within two last week
• Burkholderia cepacia infection
• Patients in lung transplantation waiting list
• Patients undergoing non invasive mechanical ventilation or oxygen therapy

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (2)

Azienda Ospedaliero-Universitaria Meyer

Florence, Italy

Location

Centro Regionale di Riferimento Fibrosi Cistica

Milan, Italy

Location

Related 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.

  PMID: 16055882 BACKGROUND

Related Links

• Standard Operating Procedures LCI

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Carla Colombo

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Technicians performing multiple-breath washout tests are blinded to treatment allocation; physiotherapists performing the treatment are blinded to multiple breath washout results; patients are blinded to the purpose of the study; the statistician will be blind to treatment allocation together with outcome assessors.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-over randomized controlled trial. Procedure: two nitrogen multiple-breath washout tests, one before and one after the intervention with PEP-Mask, either standard or sham allocation, during two subsequent mornings.

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 30, 2018
• Study Start: November 21, 2016
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 29, 2022

Record last verified: 2022-12

Locations

IT (2)