Comparison Between Conventional Respiratory Physiotherapy and the Simeox Device in Patients With Bronchiectasis

Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Jan 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different types of respiratory physiotherapy to see which one helps patients with bronchiectasis the most. It compares traditional physiotherapy methods with a new device called Simeox. The main goal is to understand how each treatment affects breathing and overall respiratory health. Researchers will measure various health indicators, including heart rate, breathing rate, and how much air patients can forcefully exhale, among other factors. They’ll also check for any side effects and ask participants about their comfort and relief during the treatment.

To qualify for the trial, participants must be at least 18 years old, have a diagnosis of bronchiectasis (not caused by cystic fibrosis), and be stable on their current treatment for at least a year. They should also be able to produce some sputum (mucus) but not too much. It's important that they haven't had any flare-ups of their condition in the month before joining the study. If you or someone you know fits these criteria, participating in this trial could help determine the best physiotherapy methods for managing bronchiectasis in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with a diagnosis of bronchiectasis not due to cystic fibrosis who are not hospitalized.
• • Age ≥ 18 years.
• • Evidence of bronchiectasis in at least one lung lobe from a chest CT scan performed within the 10 years prior to enrollment.
• • Absence of exacerbations in the 28 days preceding enrollment.
• • Sputum producers with volumes less than or equal to 200 mL/day.
• • Under treatment with optimized standard therapy for bronchiectasis that has been stable for at least one year, with no changes in the 28 days prior to enrollment.
• • Eligible for and/or already undergoing respiratory physiotherapy.
• • Signed informed consent.
• Exclusion Criteria:
• • Diagnosis of COPD or bronchial asthma interpreted as primary and predominant diseases compared to bronchiectasis.
• • Presence of tracheostomy.
• • History of significant hemoptysis (≥300 mL of blood) or requiring embolization or blood transfusions in the 4 weeks preceding enrollment.
• • Hemodynamic instability (mean arterial pressure \< 65 mmHg, heart rate \> 110 bpm).
• • Undrained pneumothorax (evident on chest X-ray, deemed not worthy of pleural drainage according to standard clinical-assistance pathways and thus subjected to follow-up).
• • Women who are pregnant or breastfeeding.