The main goal of our monocentric randomized controlled trial was to evaluate the feasibility and safety of airway clearance
with Simeox technology (Physio-Assist, France) and show non-inferiority of this technique compared to conventional manual
physiotherapy in the treatment of hospitalized patients suffering from bronchiectasis. Patients were recruited from 1st March
to 30th April 2018.
Objectives of the study
To show the non-inferiority of the Simeox device compared to traditional manual physiotherapy technique related to the
airway clearance management of hospitalized patients suffering from bronchiectasis in cystic fibrosis, COPD and idiopathic
pulmonary fibrosis.
To evaluate clinical outcomes of Simeox procedure measured by pulmonary functional tests.
To consider daily autonomous use of Simeox technology in patients with various obstructive lung diseases.
Inclusion criteria
Patients between 18-75 years, with bronchiectasis and diagnosis of cystic fibrosis, COPD or idiopathic pulmonary fibrosis (IPF),
reporting symptoms of excessive mucus production and difficulties to clear the mucus.
Methodology
Consecutive patients were randomized to reference therapy - manual physiotherapy technique performed by the
physiotherapist or Simeox procedure. Both procedures lasted 5 days with 2 sessions per day (morning and afternoon). Each
session lasted 20 minutes as a minimum (plus instructions).
Measurement of pulmonary function tests, chest expansion, oxygen saturation of haemoglobin was measured before and after
session, mucus was collected every day of the procedures.
Statistics
Median, minimal and maximal values were calculated as descriptive parameters. Two nonparametric methods were used:
Mann-Whitney U-test for independent values of two groups, paired Wilcoxon test for timely depended values. Limit of
significance was p < 0.05. Statistical software IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp was used.
Endpoints
Primary endpoint: feasibility of Simeox procedure
Secondary endpoints:
Safety of the procedure in regards of respiratory and other complications
PFTs results (FEV1, RV)
Chest expansion measured on xiphoid processus level (in cm)
SpO2 mesured by pulse oximetry (%)
24-hour collected mucus amount (ml)
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