Evaluating a device to improve breathing and swallowing in brain injury patients
Role of Expiratory Flow Acceleration in the Management of Bronchial Secrections in Severe Acquired Brain Injury: a Pilot Randomized Controlled Study
NA · Fondazione Don Carlo Gnocchi Onlus · NCT05993364
This study is testing a new device to see if it can help people with brain injuries breathe and swallow better compared to regular therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus (other) |
| Locations | 1 site (Rovato, BS) |
| Trial ID | NCT05993364 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of the Expiratory Flow Accelerator (EFA) technology in enhancing respiratory and swallowing functions in patients with acquired brain injury (ABI). Participants will undergo a baseline assessment for one week before being randomized into either a treatment group receiving EFA or a control group receiving traditional rehabilitation. The study will monitor the patients' ability to manage tracheobronchial secretions and evaluate the potential reduction in hospital-acquired pneumonia rates. The research is conducted at the Centro Ettore Spalenza-Fondazione Don Carlo Gnocchi in Rovato, Italy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have been hospitalized due to acquired brain injury and have a specific level of cognitive functioning.
Not a fit: Patients requiring mechanical ventilation for more than 12 hours a day or those with an improperly healed tracheal stoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve respiratory and swallowing functions in patients with acquired brain injury, potentially reducing complications and enhancing recovery.
How similar studies have performed: While the approach using EFA technology is innovative, similar studies have shown promise in improving respiratory functions in patients with respiratory challenges.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rovato, BS
- Fondazione Don Carlo Gnocchi - Centro Ettore Spalenza — Rovato, BS, Italy (RECRUITING)
Study contacts
- Principal investigator: Luca NC Bianchi, MD — IRCSS Fondazione Don Carlo Gnocchi
- Study coordinator: Riccardo NC Buraschi, PT
- Email: rburaschi@dongocchi.it
- Phone: +390307245282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acquired Brain Injury, Comparative Effectiveness Research, Lung Diseases, Obstructive, Expiratory Flow Accelerator, Tracheobronchial secretions, Tracheobronchial clearance, Airways clearance, Pulmonary infections