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Recruiting NCT06987461

Study of the Use of Non-invasive Ventilation in Bronchial Dilatation Disease

Observational Bronchial Dilatation Disease Bronchectasie

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Bronchial Dilatation Disease, Bronchectasie. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Study of the Use of Non-invasive Ventilation in Bronchial Dilatation Disease (BRONCHINIV)

Overview

This is a medical record data collection study. The goal of this non-interventional and retrospective study is to describe the characteristics of the population currently being monitored for bronchial dilatation who have been treated with long-term NIV. This is a study based on data from medical records. The assessment criteria will be : * Epidemiological characteristics of the population with bronchial dilatation on long-term NIV * Reasons for initiation of NIV * NIV adjustment methods

Detailed description

Non-invasive ventilation is a treatment sometimes used for severe severe bronchial dilatation, but to date there are no studies its efficacy.

The expected results in this context are :

* a description of the characteristics of patients with severe bronchial on non-invasive ventilation (NIV) * a better understanding, during NIV management, of the settings used, the tolerance and effectiveness of NIV in reducing exacerbations, hospital admissions and patient mortality. * move towards better patient management

Data will be extracted from patient medical records and the PMSI.

Primary outcome measures

  • epidemiological characteristics of the population with bronchial dilation under long-term NIV [Time frame: Through study completion, an average of 1 year]
  • Reasons for placing under NIV [Time frame: Through study completion, an average of 1 year]
  • Non-invasive ventilation adjustment modalities [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (2)
  • Number of acute exacerbations (according to international recommendations) after initiation of NIV [Time frame: Through study completion, an average of 1 year]
  • Stabilization of respiratory functional tests evolution of FEV1 (%, slope) of PaCO2 [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • Patients over 18 years
  • Predominant diagnosis of bronchiectatic disease, excluding cystic fibrosis, confirmed by computed tomography
  • Introduction of long-term NIV at a given point in the patient's care

Exclusion criteria

  • Patient's opposition to participating in this study
  • Cystic fibrosis
  • Predominant diagnosis of COPD or asthma, traction bronchiectasis, bronchiectasis resulting from focal endobronchial lesion, sarcoidosis or active allergic bronchopulmonary aspergillosis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 5 centers
  • Centre Hospitalier Intercommunal de Créteil — Créteil
  • Centre Hospitalier Universitaire Henri Mondor — Créteil
  • Centre Hospitalier Universitaire de Dijon — Dijon
  • Centre Hospitalier Universitaire de Rennes — Rennes
  • Centre Hospitalier Universitaire Toulouse — Toulouse

Identifiers

NCT: NCT06987461 · BRONCHINIV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗