Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Hyperinflation
Conditions
Keywords
COPD, Pulmonary Hyperinflation, Residual Volume, Air Trapping, Simeox, Intermittent Negative Pressure, airway Clearance, Lung Volumes, Nitrogen Washout, Spirometry, Dyspnea, Respiratory Physiotherapy, Pilot Study
Brief summary
Brief Summary People with severe chronic obstructive pulmonary disease (COPD) often have too much air trapped in their lungs (pulmonary hyperinflation). This makes it hard to breathe and reduces quality of life. This study tests whether a single session with a medical device called Simeox® can reduce the amount of air trapped in the lungs. Simeox® works by applying gentle intermittent negative pressure during exhalation to help air move out of the lungs more easily. Patients with severe or very severe COPD and documented hyperinflation will undergo lung function measurements before and immediately after a 20-minute Simeox® session. The main measurement is the change in residual volume (RV), which is the amount of air left in the lungs after a full exhalation. We will also measure changes in other lung volumes, breathlessness, and any side effects. This is a single-arm pilot study enrolling 23 patients at one center in Italy (ASST Lodi). The study is non-profit and has been approved by the Ethics Committee Comitato Etico Territoriale Lombardia 1 (CET Lombardia 1).
Detailed description
Detailed Description Pulmonary hyperinflation is a key pathophysiological feature of advanced chronic obstructive pulmonary disease (COPD), resulting from air trapping due to airflow obstruction and reduced elastic recoil. It is strongly associated with dyspnea, exercise intolerance, and impaired quality of life. Reducing residual volume (RV) is therefore a clinically meaningful therapeutic target in patients with severe and very severe COPD. Simeox® is a CE-marked electro-medical device currently used in clinical practice for bronchial secretion drainage. It applies intermittent negative pressure at high frequency (6-12 Hertz, Hz) during the expiratory phase, with the aim of increasing expiratory flow velocity and promoting air mobilization. While the device is routinely used in patients with bronchial hypersecretion, its potential effect on static lung volumes in patients with hyperinflation - regardless of the presence of significant secretions - has not been systematically investigated. This prospective, single-arm, non-controlled pilot study aims to explore the immediate effect of a single Simeox® session on RV in patients with severe or very severe COPD and documented pulmonary hyperinflation. Study procedure: Each participant undergoes baseline lung function assessment using spirometry and nitrogen wash-out (N₂ wash-out), followed by a single Simeox® treatment session lasting approximately 20 minutes (4 series of 10 tidal breathing cycles in a seated position, with rest breaks according to tolerance). During each breathing cycle, the patient performs slow controlled exhalations while the device applies high-frequency intermittent negative pressure modulated to the maximum tolerated intensity. Lung function measurements are repeated immediately after the session (within 30 minutes). Safety monitoring: Respiratory rate, heart rate, and peripheral oxygen saturation (SpO₂) are monitored throughout the session. Adverse events are recorded and classified by type, severity, and relationship to the treatment. Tolerability is assessed through subjective patient rating and dyspnea score variation. Statistical analysis: Pre- and post-intervention comparisons will be performed using a paired t-test or Wilcoxon signed-rank test depending on data distribution (significance level p \< 0.05). Sample size was calculated based on a clinically meaningful RV reduction of 0.40 L (standard deviation, SD: 0.60 L), yielding a minimum of 21 patients (80% power, α = 0.05), with 23 patients planned to account for dropouts. This pilot study will provide the methodological basis for designing a future randomized controlled trial (RCT) with a larger sample and longer follow-up.
Interventions
DEVICESimeox
Single treatment session of approximately 20 minutes with the Simeox® electro-medical device. The session consists of 4 series of 10 tidal breathing cycles performed in a seated position, with rest breaks according to patient tolerance. During each breathing cycle, the patient performs slow controlled exhalations while the device applies high-frequency intermittent negative pressure (6-12 Hz), modulated to the maximum tolerated intensity. Treatment efficacy is monitored through visual indicators integrated into the device.
Sponsors
Azienda Socio Sanitaria Territoriale di Lodi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Diagnosis of severe or very severe COPD (GOLD stage 3-4) * Documented pulmonary hyperinflation defined by at least one of the following criteria measured by nitrogen wash-out (N₂ wash-out): * Residual volume (RV) \> 150% of predicted * Functional residual capacity (FRC) \> 130% of predicted * Total lung capacity (TLC) \> 120% of predicted * RV/TLC ratio \> 40% * Clinical stability (no exacerbations in the 3 weeks prior to enrollment) * Patients for whom assessment of the effect of Simeox® on reduction of pulmonary hyperinflation is considered clinically appropriate, in the context of exploratory device use * Written informed consent
Exclusion criteria
* Active or recent pneumothorax (\< 6 weeks), predisposition to pneumothorax or pneumomediastinum, or known pleural fragility * Active or recent gross haemoptysis (\< 6 weeks) or active pulmonary haemorrhage * Haemodynamic instability * Unstable cardiovascular conditions, including: * Recent myocardial infarction * Unstable angina * Uncontrolled arrhythmias * Unstable heart failure * Recent cardiothoracic surgery (\< 3 months), including oesophageal surgery * Recent thoracic trauma or severe acute lung injury * Continuous mechanical ventilation, active need for inspiratory assistance, or tracheostomy * Neuromuscular diseases with respiratory muscle weakness * Inspiratory muscle weakness precluding increased respiratory effort * Oropharyngeal or oral muscle weakness * Inability to cough effectively, forcefully and autonomously * Severe restrictive lung disease (TLC \< 60% of predicted) * Airways at risk of aspiration (e.g. recent nasogastric tube feeding) * Uncontrolled gastro-oesophageal reflux disease (GERD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Residual Volume (RV) | Baseline and within 30 minutes after the end of the treatment session | Absolute change in residual volume (ΔRV, liters) measured by nitrogen wash-out (N₂ wash-out) before and immediately after a single Simeox® treatment session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Residual Capacity (FRC) | Baseline and within 30 minutes after the end of the treatment session | Absolute change in functional residual capacity (ΔFRC, liters) measured by nitrogen wash-out (N₂ wash-out) before and immediately after the treatment session |
| Change in Vital Capacity (VC) | Baseline and within 30 minutes after the end of the treatment session | Absolute change in vital capacity (ΔVC, liters) measured by spirometry before and immediately after the treatment session |
| Change in Dyspnea Score | Baseline and within 30 minutes after the end of the treatment session | Change in dyspnea assessed using the modified Borg CR10 scale (range 0-10; higher scores indicate greater dyspnea) before and immediately after the treatment session |
| Incidence of Adverse Events | From the start of the treatment session up to 30 minutes after session completion | Number and type of adverse events classified by severity (mild, moderate, severe) and relationship to the treatment (related, probably related, unrelated) |
| Treatment Tolerability | From the start of the treatment session up to 30 minutes after session completion | Tolerability assessed by subjective patient rating at the end of the session (tolerated / poorly tolerated / not tolerated) and by the need to interrupt or modify the session due to discomfort or adverse symptoms |
Countries
Italy
Contacts
CONTACTAndrea Di Matteo, dr
Outcome results
None listed