xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05993364</url>
    </required_header>
    <id_info>
      <org_study_id>EFA-ABI</org_study_id>
      <nct_id>NCT05993364</nct_id>
    </id_info>
    <brief_title>Efficacy of EFA in Acquired Brain Injury</brief_title>
    <official_title>Role of Expiratory Flow Acceleration in the Management of Bronchial Secrections in Severe Acquired Brain Injury: a Pilot Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Don Carlo Gnocchi Onlus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Don Carlo Gnocchi Onlus</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Acquired brain injury (ABI) is one of the biggest cause of death and disability in the world.&#xD;
        Patients with ABI often have difficulties with swallow and breath.&#xD;
  &#xD;
        The study purpose is to evaluate if the Expiratory Flow Accelerator (EFA) technology has&#xD;
        positive effects on the respiratory and swallowing function in patients with acquired brain&#xD;
        injury (ABI). Researchers recruit patients at Centro Ettore Spalenza-Fondazione Don Carlo&#xD;
        Gnocchi in Rovato, Italy.&#xD;
  &#xD;
        To partecipate, patients should satisfy certain eligibility criteria; they will not be&#xD;
        enrolled if they satisfy exclusion criteria.&#xD;
  &#xD;
        If a patient can be recruited, researchers do a swallow, consciousness and respiratory&#xD;
        assessment with him. After that, the patient will be randomized to the study or control&#xD;
        group. If the patient is in the control group, he will receive a traditional rehabilitation&#xD;
        treatment. Otherwise, the patient will receive an additional treatment with the EFA device.&#xD;
  &#xD;
        Researchers will assess again the patient (with the same tools of the previous assessment)&#xD;
        after 12 weeks of treatment. They want to see if the EFA device could help patients with ABI&#xD;
        to improve their health conditions.&#xD;
  &#xD;
        The study will last extensively from January 2023 to December 2024.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Acquired Brain Injury (ABI) is one of the most frequent cause of death and disability&#xD;
        worldwide. Swallowing disorders and cough insufficiency followed by pulmonary infections and&#xD;
        a bad secretions management are some of the associated complications. When a tracheal cannula&#xD;
        is applied, the patient conditions could get worse. Unfortunately ABI patients often can't&#xD;
        properly collaborate to the treatment/assessment processes due to their consciousness&#xD;
        disorders. According to all these reasons, ABI patients need a multi-professional assistance&#xD;
        focused on swallowing and respiratory rehabilitative treatments to improve their health&#xD;
        conditions.&#xD;
  &#xD;
        Free Aspire device with Expiratory Flow Accelerator (EFA) technology, thanks to the&#xD;
        expiratory flow acceleration, allows to remove tracheobronchial secretions and an improvement&#xD;
        of the swallowing ability.&#xD;
  &#xD;
        EFA, compared to other devices, is simple to use and does not require the active&#xD;
        collaboration of the patient. Indeed, the purpose of the study is to investigate its effects&#xD;
        on swallowing and respiratory functions. Besides, investigators want to see if EFA can speed&#xD;
        up the decannulation process.&#xD;
  &#xD;
        Patients will be recruited following accurate inclusion/exclusion criteria from June 2023 to&#xD;
        December 2024 at Centro Ettore Spalenza-Fondazione Don Carlo Gnocchi in Rovato, Italy.&#xD;
  &#xD;
        At T0, every patient that satisfy the inclusion criteria undergoes:&#xD;
  &#xD;
          -  An assessment of the state of consciousness using Levels of Cognitive Functioning Scale&#xD;
             (LCFS);&#xD;
  &#xD;
          -  A cranial nerve evaluation using Cranial Nerve Examination for Neurogenic Dysphagia&#xD;
             Patients-I&amp;I Test;&#xD;
  &#xD;
          -  Oral motor skills evaluation using Oral Apraxia and Aphasia;&#xD;
  &#xD;
          -  Fiberoptic Endoscopic Evaluation of Swallowing (FEES) to investigate directly the&#xD;
             swallowing function, using the Penetration-Aspiration Scale (PAS) and the Pooling&#xD;
             Score-P-Score;&#xD;
  &#xD;
          -  Clinic evaluation of swallowing using Drooling Frequency and Severity Scale (DFSS) to&#xD;
             assess the severity of drooling;&#xD;
  &#xD;
          -  Clinic evaluation of the secretions management using the Evans Blue Dye Test (if a&#xD;
             tracheal cannula is applied);&#xD;
  &#xD;
          -  Swallowing trials with different consistencies of food;&#xD;
  &#xD;
          -  Quantification of the patient type of diet using the Italian version of the Food and&#xD;
             Oral Intake (FOIS-it).&#xD;
  &#xD;
        Every patient undergoes the same evaluation after 12 weeks of treatment (T1). After T0,&#xD;
        patients will be randomized to the control or to the experimental group.&#xD;
  &#xD;
        The control group receives standard rehabilitation treatments carried out by physical&#xD;
        therapists and speech and language pathologists. This treatment takes place every day (from&#xD;
        Monday to Saturday) in daily sessions that lasts from 30 to 60 minutes each.&#xD;
  &#xD;
        In addition to that, the experimental group undergoes treatment sessions using Free Aspire&#xD;
        Device with Expiratory Flow Accelerator (EFA) technology, three times a day from Monday to&#xD;
        Friday and one time a day on Saturday. The sessions last 20 minutes each. EFA technology&#xD;
        generates a non invasive expiratory flow acceleration, allowing the bronchial secretions&#xD;
        removal without requiring the active collaboration of the patient. EFA could be applied&#xD;
        through the tracheal cannula, a facial mask or a mouthpiece.&#xD;
  &#xD;
        Both the control and the experimental treatments last 12 weeks. Researchers expect that the&#xD;
        experimental group shows an improvement of the tracheo-bronchial clearance and of the&#xD;
        respiratory and swallowing functions. Consequentially less episodes of pulmonary infections&#xD;
        and desaturation should happen; patients with a tracheal cannula should show earlier&#xD;
        decannulation.&#xD;
  &#xD;
        Researchers want to prove that EFA could be an effective and simple device to use in the&#xD;
        rehabilitation of patients with ABI, available to the entire multi-professional equipe,&#xD;
        caregivers included.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 5, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Reduction of pulmonary infections</measure>
      <time_frame>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.</time_frame>
      <description>Reduction of the pulmonary infections that require antibiotic therapy.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Reduction of oxyhemoglobin desaturation episodes</measure>
      <time_frame>During the data collection in the 12 weeks of treatment for each patient, the number of oxyhemoglobin desaturation episodes will be registered.</time_frame>
      <description>Reduction of the frequency of oxyhemoglobin desaturation episodes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reduction of tracheal cannula aspiration</measure>
      <time_frame>During the data collection in the 12 weeks of treatment for each patient, the number of tracheal cannula aspiration will be registered.</time_frame>
      <description>Reduction of the number of the needed aspiration in the tracheal cannula due to tracheo-bronchial obstruction</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Acquired Brain Injury</condition>
    <condition>Comparative Effectiveness Research</condition>
    <condition>Lung Diseases, Obstructive</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental group receives the same standard rehabilitative treatment performed with the control group. In addition, sessions with the EFA technology are provided.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Free Aspire with Expiratory Flow Accelerator (EFA) technology</intervention_name>
      <description>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.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>In-Exufflator Machine</intervention_name>
      <description>Sessions using the In-Exufflator machine to improve the cough function, when the oxygen saturation decreases and the bronchial secretions increases.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Traditional respiratory treatment</intervention_name>
      <description>Standard rehabilitative treatment to improve the secretions management, that includes:&#xD;
  A change of the patient posture every three hours;&#xD;
  Airways humidification depending on the secretions features;&#xD;
  Aspiration in the tracheal cannula whenever necessary.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Traditional swallowing treatment</intervention_name>
      <description>Traditional rehabilitative treatment carried out by the speech and language pathologist in order to:&#xD;
  Obtain decannulation (when a tracheal cannula is applied) following the Bargellesi Protocol steps;&#xD;
  Improve oral structures strength and motility;&#xD;
  Improve oral and perioral sensitivity with thermal or gustative or tactile stimulations;&#xD;
  Improve the swallowing function with food trials of different consistencies, volume and temperature;&#xD;
  Improve swallow efficacy and safety through the prescription of compensatory postures;&#xD;
  Session with VitalStim electrical stimulation of the laryngeal area.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age higher than 18 years old;&#xD;
  &#xD;
            -  Hospitalization after diagnosis of Acquired Brain Injury (both traumatic and vascular)&#xD;
  &#xD;
            -  Levels of Cognitive Functioning Scale (LCFS) score between 1and 5;&#xD;
  &#xD;
            -  Presence of spontaneous breathing, at least during the day&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Need of mechanical ventilation for more than 12 hours a day;&#xD;
  &#xD;
            -  Presence of tracheal stoma not properly healed after the removal of the tracheal&#xD;
               cannula.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Fondazione Don Carlo Gnocchi - Centro Ettore Spalenza</name>
        <address>
          <city>Rovato</city>
          <state>BS</state>
          <zip>25038</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Riccardo Buraschi</last_name>
        <phone>00390307245</phone>
        <phone_ext>282</phone_ext>
        <email>rburaschi@dongnocchi.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <link>
      <url>https://www.minervamedica.it/en/journals/medicina-riabilitativa/article.php?cod=R47Y2013N01A0009</url>
      <description>Bargellesi Protocol</description>
    </link>
    <link>
      <url>https://www.omicsonline.org/open-access-pdfs/cranial-nerve-examination-for-neurogenic-dysphagia-patients-2161-119X-1000319.pdf</url>
      <description>Cranial Nerve Examination for Neurogenic Dysphagia Patients-I&amp;I Test</description>
    </link>
    <reference>
      <citation>Ahmed S, Venigalla H, Mekala HM, Dar S, Hassan M, Ayub S. Traumatic Brain Injury and Neuropsychiatric Complications. Indian J Psychol Med. 2017 Mar-Apr;39(2):114-121. doi: 10.4103/0253-7176.203129.</citation>
      <PMID>28515545</PMID>
    </reference>
    <reference>
      <citation>Belli S, Cattaneo D, D'Abrosca F, Prince I, Savio G, Balbi B. A pilot study on the non-invasive management of tracheobronchial secretions in tracheostomised patients. Clin Respir J. 2019 Oct;13(10):637-642. doi: 10.1111/crj.13074. Epub 2019 Aug 26.</citation>
      <PMID>31390146</PMID>
    </reference>
    <reference>
      <citation>Borders JC, Gibson AL, Grayev A, Thibeault S. Predictors of dysphagia in critically injured patients with neck trauma. J Crit Care. 2018 Apr;44:312-317. doi: 10.1016/j.jcrc.2017.12.004. Epub 2017 Dec 7.</citation>
      <PMID>29268199</PMID>
    </reference>
    <reference>
      <citation>Bone DK, Davis JL, Zuidema GD, Cameron JL. Aspiration pneumonia. Prevention of aspiration in patients with tracheostomies. Ann Thorac Surg. 1974 Jul;18(1):30-7. doi: 10.1016/s0003-4975(10)65714-1. No abstract available.</citation>
      <PMID>4834725</PMID>
    </reference>
    <reference>
      <citation>Cook AM, Peppard A, Magnuson B. Nutrition considerations in traumatic brain injury. Nutr Clin Pract. 2008 Dec-2009 Jan;23(6):608-20. doi: 10.1177/0884533608326060.</citation>
      <PMID>19033220</PMID>
    </reference>
    <reference>
      <citation>Eskildsen SJ, Jakobsen D, Riberholt CG, Poulsen I, Curtis DJ. Protocol for a scoping review study to identify and map treatments for dysphagia following moderate to severe acquired brain injury. BMJ Open. 2019 Jul 17;9(7):e029061. doi: 10.1136/bmjopen-2019-029061.</citation>
      <PMID>31320355</PMID>
    </reference>
    <reference>
      <citation>Farneti D. Pooling score: an endoscopic model for evaluating severity of dysphagia. Acta Otorhinolaryngol Ital. 2008 Jun;28(3):135-40.</citation>
      <PMID>18646575</PMID>
    </reference>
    <reference>
      <citation>Galeoto G, Turriziani S, Berardi A, Sansoni J, Santilli V, Mascio M, Paoloni M. Levels of Cognitive Functioning Assessment Scale: Italian cross-cultural adaptation and validation. Ann Ig. 2020 Jan-Feb;32(1):16-26. doi: 10.7416/ai.2020.2326.</citation>
      <PMID>31713573</PMID>
    </reference>
    <reference>
      <citation>Lanini B, Binazzi B, Romagnoli I, Chellini E, Pianigiani L, Tofani A, Lova RM, Corbetta L, Gigliotti F. Tracheostomy decannulation in severe acquired brain injury patients: The role of flexible bronchoscopy. Pulmonology. 2021 Jul 1:S2531-0437(21)00115-X. doi: 10.1016/j.pulmoe.2021.05.006. Online ahead of print.</citation>
      <PMID>34219041</PMID>
    </reference>
    <reference>
      <citation>Ninfa A, Pizzorni N, Eplite A, Moltisanti C, Schindler A. Validation of the Italian Version of the Functional Oral Intake Scale (FOIS-It) Against Fiberoptic Endoscopic Evaluation of Swallowing and Nutritional Status. Dysphagia. 2022 Feb;37(1):137-147. doi: 10.1007/s00455-021-10257-9. Epub 2021 Feb 16.</citation>
      <PMID>33591464</PMID>
    </reference>
    <reference>
      <citation>Patrizio G, D'Andria M, D'Abrosca F, Cabiaglia A, Tanzi F, Garuti G, Nicolini A. Airway Clearance with Expiratory Flow Accelerator Technology: Effectiveness of the &quot;Free Aspire&quot; Device in Patients with Severe COPD. Turk Thorac J. 2019 Jul 30;20(4):209-215. doi: 10.5152/TurkThoracJ.2018.18053. Print 2019 Oct.</citation>
      <PMID>31390330</PMID>
    </reference>
    <reference>
      <citation>Riboldazzi G, Spinazza G, Beccarelli L, Prato P, Grecchi B, D'Abrosca F, Nicolini A. Effectiveness of expiratory flow acceleration in patients with Parkinson's disease and swallowing deficiency: A preliminary study. Clin Neurol Neurosurg. 2020 Dec;199:106249. doi: 10.1016/j.clineuro.2020.106249. Epub 2020 Sep 28.</citation>
      <PMID>33039853</PMID>
    </reference>
    <reference>
      <citation>Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.</citation>
      <PMID>8721066</PMID>
    </reference>
    <reference>
      <citation>Rotolo N, Cattoni M, D'Andria M, Cavanna L, Patrizio G, Imperatori A, Nicolini A. Comparison of an expiratory flow accelerator device versus positive expiratory pressure for tracheobronchial airway clearance after lung cancer lobectomy: a preliminary study. Physiotherapy. 2021 Mar;110:34-41. doi: 10.1016/j.physio.2019.01.011. Epub 2019 Jan 26.</citation>
      <PMID>33563372</PMID>
    </reference>
    <reference>
      <citation>Thomas-Stonell N, Greenberg J. Three treatment approaches and clinical factors in the reduction of drooling. Dysphagia. 1988;3(2):73-8. doi: 10.1007/BF02412423. No abstract available.</citation>
      <PMID>3271655</PMID>
    </reference>
    <reference>
      <citation>Ward EC, Green K, Morton AL. Patterns and predictors of swallowing resolution following adult traumatic brain injury. J Head Trauma Rehabil. 2007 May-Jun;22(3):184-91. doi: 10.1097/01.HTR.0000271119.96780.f5.</citation>
      <PMID>17510594</PMID>
    </reference>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Expiratory Flow Accelerator</keyword>
    <keyword>Tracheobronchial secretions</keyword>
    <keyword>Tracheobronchial clearance</keyword>
    <keyword>Airways clearance</keyword>
    <keyword>Pulmonary infections</keyword>
    <keyword>Pulmonary obstruction</keyword>
    <keyword>Decannulation</keyword>
    <keyword>Tracheal cannula</keyword>
    <keyword>Effectiveness</keyword>
    <keyword>Acquired Brain Injury</keyword>
    <keyword>Controlled study</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Obstructive</mesh_term>
      <mesh_term>Brain Injuries</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05993364
  org study id: EFA-ABI
  nct id: NCT05993364
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Reduction of pulmonary infections
  time frame: 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.
  description: Reduction of the pulmonary infections that require antibiotic therapy.
  measure: Reduction of oxyhemoglobin desaturation episodes
  time frame: During the data collection in the 12 weeks of treatment for each patient, the number of oxyhemoglobin desaturation episodes will be registered.
  description: Reduction of the frequency of oxyhemoglobin desaturation episodes.
  measure: Reduction of tracheal cannula aspiration
  time frame: During the data collection in the 12 weeks of treatment for each patient, the number of tracheal cannula aspiration will be registered.
  description: Reduction of the number of the needed aspiration in the tracheal cannula due to tracheo-bronchial obstruction
  arm group label: Control group
  arm group type: Active Comparator
  description: 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.
  arm group label: Experimental group
  arm group type: Experimental
  description: The experimental group receives the same standard rehabilitative treatment performed with the control group. In addition, sessions with the EFA technology are provided.
  intervention type: Device
  intervention name: Free Aspire with Expiratory Flow Accelerator (EFA) technology
  description: 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.
  arm group label: Experimental group
  intervention type: Device
  intervention name: In-Exufflator Machine
  description: Sessions using the In-Exufflator machine to improve the cough function, when the oxygen saturation decreases and the bronchial secretions increases.
  arm group label: Control group
  arm group label: Experimental group
  intervention type: Other
  intervention name: Traditional respiratory treatment
  description: 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.
  arm group label: Control group
  arm group label: Experimental group
  intervention type: Other
  intervention name: Traditional swallowing treatment
  description: 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.
  arm group label: Control group
  arm group label: Experimental group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  url: https://www.minervamedica.it/en/journals/medicina-riabilitativa/article.php?cod=R47Y2013N01A0009
  description: Bargellesi Protocol
  url: https://www.omicsonline.org/open-access-pdfs/cranial-nerve-examination-for-neurogenic-dysphagia-patients-2161-119X-1000319.pdf
  description: Cranial Nerve Examination for Neurogenic Dysphagia Patients-I&I Test
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  PMID: 28515545
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  PMID: 17510594
  responsible party type: Sponsor
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Obstructive
  mesh term: Brain Injuries
  mesh term: Wounds and Injuries
  sharing ipd: No