Evaluating the Effects of Simeox4 Device on Lung Air Trapping in Adults with Severe COPD and Pulmonary Hyperinflation

What this Trial Is About

People with severe or very severe chronic obstructive pulmonary disease COPD often have pulmonary hyperinflation, where too much air is trapped in the lungs. This condition causes difficulty breathing and lowers quality of life. This study evaluates the immediate effect of a single session with a medical device called Simeox4, which applies gentle intermittent negative pressure during exhalation to help move air out of the lungs more easily. The research aims to explore whether this device can reduce residual volume, the amount of air left in the lungs after a full exhalation. Participants undergo lung function tests before and immediately after a 20-minute Simeox4 session, which consists of four sets of ten slow, controlled breathing cycles while seated. During exhalation, the device applies high-frequency negative pressure adjusted to the maximum intensity tolerated by the patient. Lung function is measured using spirometry and nitrogen wash-out techniques. No control group is involved as all enrolled patients receive the Simeox4 treatment. Throughout the session, vital signs such as respiratory rate, heart rate, and oxygen saturation are monitored. Researchers track any side effects and assess how well participants tolerate the treatment. The main outcome is the change in residual volume measured within 30 minutes after treatment. Other lung volumes, breathlessness scores, and safety information are also recorded. This pilot study of 23 patients serves as a foundation for future larger trials with longer follow-up periods.

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