20
Participants
Start Date
February 19, 2024
Primary Completion Date
February 28, 2025
Study Completion Date
December 31, 2025
Free Aspire with Expiratory Flow Accelerator (EFA) technology
Treatment sessions during which the EFA technology is used. Depending on the patient's clinical conditions, an oxygen additional support can be provided, while using the device. If present, during the sessions the tracheal cannula must be cuffed. Tracheal cannula aspiration must be provided when necessary. Sessions take place three times a day and take 20 minutes each time, from Monday to Saturday.
In-Exufflator Machine
Sessions using the In-Exufflator machine to improve the cough function, when the oxygen saturation decreases and the bronchial secretions increases.
Traditional respiratory treatment
"Standard rehabilitative treatment to improve the secretions management, that includes:~* A change of the patient posture every three hours;~* Airways humidification depending on the secretions features;~* Aspiration in the tracheal cannula whenever necessary."
Traditional swallowing treatment
"Traditional rehabilitative treatment carried out by the speech and language pathologist in order to:~* Obtain decannulation (when a tracheal cannula is applied) following the Bargellesi Protocol steps;~* Improve oral structures strength and motility;~* Improve oral and perioral sensitivity with thermal or gustative or tactile stimulations;~* Improve the swallowing function with food trials of different consistencies, volume and temperature;~* Improve swallow efficacy and safety through the prescription of compensatory postures;"
RECRUITING
Fondazione Don Carlo Gnocchi - Centro Ettore Spalenza, Rovato
Fondazione Don Carlo Gnocchi Onlus
OTHER