Efficacy of EFA in Acquired Brain Injury

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 19, 2024

Primary Completion Date

February 28, 2025

Study Completion Date

December 31, 2025

Conditions
Acquired Brain InjuryComparative Effectiveness ResearchLung Diseases, Obstructive
Interventions
DEVICE

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.

DEVICE

In-Exufflator Machine

Sessions using the In-Exufflator machine to improve the cough function, when the oxygen saturation decreases and the bronchial secretions increases.

OTHER

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."

OTHER

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;"

Trial Locations (1)

25038

RECRUITING

Fondazione Don Carlo Gnocchi - Centro Ettore Spalenza, Rovato

All Listed Sponsors
lead

Fondazione Don Carlo Gnocchi Onlus

OTHER