Efficacy of EFA in Acquired Brain Injury

Launched by FONDAZIONE DON CARLO GNOCCHI ONLUS · Aug 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Expiratory Flow Accelerator (EFA) to see if it can help improve breathing and swallowing for patients with acquired brain injury (ABI). ABI can happen due to accidents or strokes and often leads to serious challenges in daily activities, including eating and breathing. The trial is taking place at a hospital in Italy, and researchers are looking for participants who are over 18, have been hospitalized due to ABI, and can breathe on their own at least during the day.

If a patient is eligible and agrees to participate, they will first be assessed for one week. Then, they will be randomly assigned to either the study group, which will receive treatment with the EFA device, or a control group, which will receive standard rehabilitation. After 8 weeks of treatment, the researchers will check in again to see if the EFA device has made a positive difference in the patients’ health. This study aims to find out if this new technology can provide better outcomes for people recovering from ABI.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age higher than 18 years old;
• • Hospitalization after diagnosis of Acquired Brain Injury (both traumatic and vascular)
• • Levels of Cognitive Functioning Scale (LCFS) score between 1and 5;
• • Presence of spontaneous breathing, at least during the day
• Exclusion Criteria:
• • Need of mechanical ventilation for more than 12 hours a day;
• • Presence of tracheal stoma not properly healed after the removal of the tracheal cannula.