Respiratory Physiotherapy Performed by Simeox In Patients With Primary Ciliary Dyskinesia
- Conditions
- Primary Ciliary Dyskinesia
- Interventions
- Device: SimeoxDevice: PARI O PEP
- Registration Number
- NCT04793724
- Lead Sponsor
- University Hospital, Motol
- Brief Summary
Primary ciliary dyskinesia (PCD) is characterized by impaired airway clearance and mucus stagnation. This results in recurrent upper and lower respiratory tract infections often leading to chronic inflammation and, if not treated early and properly, to irreversible functional and structural changes of the respiratory tract. As there is no causal treatment of PCD yet, airway clearance techniques (ACT) provide fundamental care for these patients.
Simeox is a new airway clearance device, recently developed by the French company PhysioAssist. This technology is based on pneumatic vibrations generated by the device itself. Vibrations are induced by rapidly alternating between atmospheric and negative pressure as the patient exhales, providing the most effective clearance of mucus from the lungs. Vibrations of different intensity and frequency are known to alter the rheological properties of mucus in the airways, whilst the negative pressure during exhalation helps to mobilise and drain the mucus to the central bronchi.
Although there have not yet been any evidence based papers published clarifying the effect of Simeox specifically in patients with PCD, using up-to-date information, experience, and positive feedback from our patients, we assume that there could be a significant benefit for the effectiveness of ACT.
- Detailed Description
In this study the effectiveness of ACT will be evaluated based on the short-term effect(s) of respiratory physiotherapy with Simeox on changes in lung function and thoracic expansibility paediatric patients with PCD.
An interventional randomised non-inferiority crossover trial will be conducted in Motol University Hospital; the project was developed by the multidisciplinary team (MDT) of the Division of Paediatric Pulmonology of the Department of Paediatrics, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital; and the Department of Rehabilitation and Sports Medicine, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital.
Eligible patients will be randomly assigned into 2 arms - "Simeox-first group" and "Pari-O-PEP first" group. Randomisation will be done using computer generated code for each patient. The protocol will include 3 study visits - K0, K1 and K2 planned 3 months apart. After 6 months (second visit - K1), each patient will be switched to the other interventional group (crossed over). The first session (K0) includes an initial lung function assessment using spirometry, nitrogen-Multiple Breath Washout test (N2-MBW), Electrical Impedance Tomography (EIT), 6 Minute Walk Test (6 MWT), respiratory amplitudes (RA), and a theoretical introduction to therapy with the Simeox device. The second (K1) and third (K2) sessions will be interventional, including a respiratory physiotherapy session in between each measurement, excluding 6 MWT, which will be measured just once per session.
According to randomisation criteria, participants will initially undergo either physiotherapist-administered 20-minute ACT session using the Simeox device or 30-minute therapy with PARI O-PEP. In accordance with the rules for crossover study design, each patient will undergo therapy with both ACT devices, ideally within six-month duration of the study. These interventions will take place in between each measurement (spirometry, MBW, EIT, RA) during the second (K1) and the third (K2) session.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- diagnosis of PCD confirmed by Transmission Electron Microscopy (TEM) analysis of ciliary ultrastructure showing clear structural axonemal defect and/or positive genetic testing for one (autosomal dominant) or two (autosomal recesive) PCD-causing mutations;
- age range 4 - 18 years;
- established chest physiotherapy with PARI O PEP
- inability to undergo the assessment and intervention
- noncompliance and/or nonadherence
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Simeox first Simeox Patients who will undergo Simeox intervention first. After three months cross-over to PARI O PEP intervention. PARI O PEP first PARI O PEP Patients who will undergo PARI O PEP intervention first. After three months cross-over to Simeox intervention.
- Primary Outcome Measures
Name Time Method Change in Lung Clearance Index Through study completion, an average of 1 year Ventilation Inhomogenity Assesment
- Secondary Outcome Measures
Name Time Method Change in Forced Residual Capacity (FRC) Through study completion, an average of 1 year Volume of air present in the lungs at the end of passive expiration, in Litres \[L\].
Change in Maximal Expiratory Flow (MEF25-75) Through study completion, an average of 1 year Volume of air where the certain amount (25-75%) of Forced Vital Capacity (FVC) remains to be exhaled, in Litres \[L\]
Change in Forced Vital Capacity (FVC) Through study completion, an average of 1 year Volume of air that can forcibly be blown out after full inspiration, in Litres \[L\]
Change in Forced Expiratory Volume in 1 second (FEV1) Through study completion, an average of 1 year Volume of air exhaled in the first second during forced exhalation after full inspiration, in Litres per second \[L/s\]
Change in Acinar airway inhomogeneity (Sacin) Through study completion, an average of 1 year MBW indices reflecting ventilation inhomogeneity in the acinar airway region, in Litres \[L\]
Change in Conductive airway inhomogeneity (Scond) Through study completion, an average of 1 year MBW indices reflecting ventilation inhomogeneity in the conductive airway region, in Litres \[L\]
Trial Locations
- Locations (1)
Motol University Hospital
🇨🇿Praha, Praha 5, Czechia