Efficacy of EFA in Acquired Brain Injury

Study Overview
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Brief Summary
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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 do a swallow, consciousness and respiratory assessment with him. 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 tools of the previous assessment) after 12 weeks of treatment. They want to see if the EFA device could help patients with ABI to improve their health conditions. The study will last extensively from January 2023 to December 2024.

Detailed Description
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Acquired Brain Injury (ABI) is one of the most frequent cause of death and disability worldwide. Swallowing disorders and cough insufficiency followed by pulmonary infections and a bad secretions management are some of the associated complications. When a tracheal cannula is applied, the patient conditions could get worse. Unfortunately ABI patients often can't properly collaborate to the treatment/assessment processes due to their consciousness disorders. According to all these reasons, ABI patients need a multi-professional assistance focused on swallowing and respiratory rehabilitative treatments to improve their health conditions. Free Aspire device with Expiratory Flow Accelerator (EFA) technology, thanks to the expiratory flow acceleration, allows to remove tracheobronchial secretions and an improvement of the swallowing ability. EFA, compared to other devices, is simple to use and does not require the active collaboration of the patient. Indeed, the purpose of the study is to investigate its effects on swallowing and respiratory functions. Besides, investigators want to see if EFA can speed up the decannulation process. Patients will be recruited following accurate inclusion/exclusion criteria from June 2023 to December 2024 at Centro Ettore Spalenza-Fondazione Don Carlo Gnocchi in Rovato, Italy. At T0, every patient that satisfy the inclusion criteria undergoes: An assessment of the state of consciousness using Levels of Cognitive Functioning Scale (LCFS); A cranial nerve evaluation using Cranial Nerve Examination for Neurogenic Dysphagia Patients-I&I Test; Oral motor skills evaluation using Oral Apraxia and Aphasia; Fiberoptic Endoscopic Evaluation of Swallowing (FEES) to investigate directly the swallowing function, using the Penetration-Aspiration Scale (PAS) and the Pooling Score-P-Score; Clinic evaluation of swallowing using Drooling Frequency and Severity Scale (DFSS) to assess the severity of drooling; Clinic evaluation of the secretions management using the Evans Blue Dye Test (if a tracheal cannula is applied); Swallowing trials with different consistencies of food; Quantification of the patient type of diet using the Italian version of the Food and Oral Intake (FOIS-it). Every patient undergoes the same evaluation after 12 weeks of treatment (T1). After T0, patients will be randomized to the control or to the experimental group. The control group receives standard rehabilitation treatments carried out by physical therapists and speech and language pathologists. This treatment takes place every day (from Monday to Saturday) in daily sessions that lasts from 30 to 60 minutes each. In addition to that, the experimental group undergoes treatment sessions using Free Aspire Device with Expiratory Flow Accelerator (EFA) technology, three times a day from Monday to Friday and one time a day on Saturday. The sessions last 20 minutes each. EFA technology generates a non invasive expiratory flow acceleration, allowing the bronchial secretions removal without requiring the active collaboration of the patient. EFA could be applied through the tracheal cannula, a facial mask or a mouthpiece. Both the control and the experimental treatments last 12 weeks. Researchers expect that the experimental group shows an improvement of the tracheo-bronchial clearance and of the respiratory and swallowing functions. Consequentially less episodes of pulmonary infections and desaturation should happen; patients with a tracheal cannula should show earlier decannulation. Researchers want to prove that EFA could be an effective and simple device to use in the rehabilitation of patients with ABI, available to the entire multi-professional equipe, caregivers included.

Official Title
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Role of Expiratory Flow Acceleration in the Management of Bronchial Secrections in Severe Acquired Brain Injury: a Pilot Randomized Controlled Study

Conditions
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Acquired Brain Injury, Comparative Effectiveness Research, Lung Diseases, Obstructive

Intervention / Treatment
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* Device: Free Aspire with Expiratory Flow Accelerator (EFA) technology
* Device: In-Exufflator Machine
* Other: Traditional respiratory treatment
* Other: Traditional swallowing treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>The control group receive a standard rehabilitative treatment to improve the secretions management and the respiratory function. Besides, the control group receives a traditional rehabilitative treatment carried out by the speech and language pathologist. | Device: In-Exufflator Machine<br>* Sessions using the In-Exufflator machine to improve the cough function, when the oxygen saturation decreases and the bronchial secretions increases.<br>Other: Traditional respiratory treatment<br>* 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.<br>Other: Traditional swallowing treatment<br>* 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; Session with VitalStim electrical stimulation of the laryngeal area.<br>|
| Experimental: Experimental group<br>The experimental group receives the same standard rehabilitative treatment performed with the control group. In addition, sessions with the EFA technology are provided. | Device: Free Aspire with Expiratory Flow Accelerator (EFA) technology<br>* 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.<br>Device: In-Exufflator Machine<br>* Sessions using the In-Exufflator machine to improve the cough function, when the oxygen saturation decreases and the bronchial secretions increases.<br>Other: Traditional respiratory treatment<br>* 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.<br>Other: Traditional swallowing treatment<br>* 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; Session with VitalStim electrical stimulation of the laryngeal area.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of pulmonary infections | Reduction of the pulmonary infections that require antibiotic therapy. | During the data collection in the 12 weeks of treatment for each patient, the number of pulmonary infections that require an antibiotic treatment will be registered. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of oxyhemoglobin desaturation episodes | Reduction of the frequency of oxyhemoglobin desaturation episodes. | During the data collection in the 12 weeks of treatment for each patient, the number of oxyhemoglobin desaturation episodes will be registered. | 
| Reduction of tracheal cannula aspiration | Reduction of the number of the needed aspiration in the tracheal cannula due to tracheo-bronchial obstruction | During the data collection in the 12 weeks of treatment for each patient, the number of tracheal cannula aspiration will be registered. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Expiratory Flow Accelerator, Tracheobronchial secretions, Tracheobronchial clearance, Airways clearance, Pulmonary infections, Pulmonary obstruction, Decannulation, Tracheal cannula, Effectiveness, Acquired Brain Injury, Controlled study