Effect of Simeox® on Residual Volume in COPD Patients With Pulmonary Hyperinflation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Socio Sanitaria Territoriale di Lodi

About this trial

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).

Eligibility criteria

Qualifiers

Age ≥ 18 years

Diagnosis of severe or very severe COPD (GOLD stage 3-4)

Residual volume (RV) > 150% of predicted

Functional residual capacity (FRC) > 130% of predicted

Disqualifiers

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

Recent myocardial infarction

Trial design

Treatments tested in this trial

  • Simeox

Treatment groups

23 Participants
are divided into 1 treatment group