Recruitment

12 patients were included, 6 in each arm. All of them achieved planned procedures. 7 men and 5 women. Mean age was 46.5

years (53.1 and 39.3 years in Simeox and manual physiotherapy groups, respectively).

7 patients had cystic fibrosis (2 in Simeox group), 3 had COPD (2 in Simeox group), and 2 patients had IPF (both in Simeox group).

Results

Table 1 shows PFTs results in both arms. There were no statistical difference inside the groups despite a trend in FEV1

improvement. Chest expansion increased both after Simeox and manual physiotherapy.

There were also no significant difference in pulmonary function tests or sputum production, between both groups (Table 2).

SpO2 increased in both arms. The changes were partially significant (p<0.01) as shown in table 3. The changes of SpO2 were not

statistically different between the two groups (Table 4). However, regression analysis showed a longitudinal rise of SpO2 median

assessed before procedure in the Simeox group only (Graph 1, Table 5).

Safety and feasibility

Simeox procedure was tolerated by all patients. Functions of Simeox were easily understood and proper handling was simple for

every patient. No safety signal was detected. Patients appreciated the device and found it comfortable.

Conclusions

Our prospective study showed noninferiority of Simeox procedure compared to manual physiotherapy technique. After 5 days

of therapy similar results were achieved by both methods. Significant improvement of chest expansion and oxygen saturation of

haemoglobin were observed in both study groups. A positive longitudinal trend of SpO2 median before procedure was observed

only in the Simeox group.

Simeox procedure was well tolerated by all patients and the device was considered safe and feasibile for treatment of various

lung diseases with mucus retention.

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