Evaluating Expiratory Flow Accelerator EFA Device to Improve Breathing and Swallowing in Adults with Acquired Brain Injury

What this Trial Is About

Acquired Brain Injury ABI is a leading cause of death and disability worldwide, often causing difficulties with swallowing and breathing. This research investigates whether the Expiratory Flow Accelerator EFA device can improve respiratory and swallowing functions in patients with ABI. The study is conducted at Centro Ettore Spalenza-Fondazione Don Carlo Gnocchi in Rovato, Italy, aiming to reduce complications like hospital-acquired pneumonia and improve tracheotomy weaning. Patients first undergo a one-week baseline assessment measuring oxygen saturation, oxygen supply, desaturation episodes, tracheal cannula aspirations, and antibiotic treatments for pneumonia. After this, they are randomly assigned to either a control group receiving standard rehabilitation treatments or an experimental group receiving the same rehabilitation plus additional sessions with the EFA device. The EFA treatment occurs three times daily Monday to Friday and once on Saturday, each lasting 20 minutes, using the device via tracheal cannula, facial mask, or mouthpiece. Participants are monitored throughout the 8-week treatment period with weekly arterial blood gas analyses and repeated assessments of the baseline measures. Researchers focus on the number of oxyhemoglobin desaturation episodes as the primary outcome, along with secondary measures like tracheal aspiration frequency, pneumonia incidence, tracheostomy weaning time, and staff satisfaction. The study aims to assess if EFA improves airway clearance and respiratory health in ABI patients.

Efficacy of EFA in Acquired Brain Injury