Efficacy of EFA in Acquired Brain Injury

Summary

Acquired brain injury (ABI) is one of the biggest cause of death and disability in the world. Patients with ABI often have difficulties with swallow and breath.

The study purpose is to evaluate if the Expiratory Flow Accelerator (EFA) technology has positive effects on the respiratory and swallowing function in patients with acquired brain injury (ABI). Researchers recruit patients at Centro Ettore Spalenza-Fondazione Don Carlo Gnocchi in Rovato, Italy.

To partecipate, patients should satisfy certain eligibility criteria; they will not be enrolled if they satisfy exclusion criteria.

If a patient can be recruited, researchers conduct the baseline assessment lasting 1 one week. After that, the patient will be randomized to the study or control group. If the patient is in the control group, he will receive a traditional rehabilitation treatment. Otherwise, the patient will receive an additional treatment with the EFA device.

Researchers will assess again the patient (with the same procedures of baseline assessment) after 8 weeks of treatment. They want to see if the EFA device could help patients with ABI to improve their health conditions.

Conditions

• Acquired Brain Injury
• Comparative Effectiveness Research
• Lung 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;

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus

  lead OTHER

Principal Investigators

• Luca NC Bianchi, MD · IRCSS Fondazione Don Carlo Gnocchi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-19

Primary Completion

2025-02-28

Completion

2025-12-31

Countries

• Italy

Study Locations