Physiotherapy is a key treatment for patients with bronchiectasis. An evaluation of the parameters indicative of respiratory health in patients treated with two different respiratory physiotherapy techniques (conventional versus Simeox®) would be very useful in choosing physiotherapy treatments for bronchiectasis patients. A systematic review of the literature shows that there are no published studies evaluating the effectiveness of respiratory physiotherapy by analyzing the variation in resistance measured using the forced oscillation technique (FOT) in patients with bronchiectasis. The results of this study would add to those that have examined different physiotherapy techniques and could therefore contribute to the choice of the most appropriate technique for this category of patients.
The trial is being conducted to answer the question: "How do respiratory parameters vary during treatment with two different respiratory physiotherapy techniques: conventional respiratory physiotherapy or that performed using the Simeox device?" Secondary objectives include the measurement of various functional parameters, such as vital signs (heart rate, respiratory rate, blood oxygenation, blood pressure values) and spirometry values (FEV1, FVC, TLC). The onset of adverse events, the degree of patient tolerance and relief, and respiratory health will also be assessed through the administration of various questionnaires commonly used in clinical practice. Additionally, changes in the quantity of sputum produced will be measured.
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.
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).
Crossover
Simeox
DeviceThe Investigators chose to evaluate this device for respiratory physiotherapy in our patients because it is the only one that offers innovative technology, as, unlike other commercially available devices, it does not require the patient to perform forced breathing. Instead, the patient can exhale calmly at tidal volume. This is expected to reduce the patient's effort and improve compliance with treatment. Furthermore, the vibratory signal with small, rapid, and sequential depressions within the airways could be more effective in mobilizing mucus from the airways, preventing collapse.
Measurement of respiratory mechanics (airway resistance)
Airway resistance at 5 Hz (R5) and airway resistance at 20 Hz (R20) measured in cmH2O/L/sec, using Forced Oscillometry Technique (FOT)
Evaluation of Respiratory Rate
RR: Breath/Minutes
Evaluation of blood oxygen
SpO2 (%)
Evaluation of hearth rate
HR (bpm)
Evaluation of blood pressure
Diastolic BP (mmHg) and Sistolic BP (mmHg)
Click on the lead sponsor to view all of their trials.
