Study Results
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Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-02-19
2025-12-31
Brief Summary
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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.
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Detailed Description
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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 secretion management ability and to evaluate if EFA can reduce the frequency of Hospital Acquired Pneumonia (HAP). In addition, the study evaluates the effectiveness of EFA in accelerating tracheotomy weaning.
Patients will be recruited following accurate inclusion/exclusion criteria at Centro Ettore Spalenza-Fondazione Don Carlo Gnocchi in Rovato, Italy.
At baseline assessment (1 week), the following parameters will be assessed daily for each patient recruited:
* Saturation of Peripheral Oxygen (Sp02)
* Oxygen supply as fraction of inspired oxygen (Fi02)
* Number of oxyhemoglobin desaturation episodes.
* Number of the needed aspiration in the tracheal cannula due to tracheo-bronchial obstruction.
* Number of and duration of antibiotic therapy courses due to HAP.
After baseline evaluation, patients will be randomized to the control or to the experimental group.
Every patient undergoes the same evaluation during the 8 weeks of treatment. Additionally, an arterial blood gas analysis will be performed every week for clinically monitoring the patients recruited.
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 8 weeks. Researchers expect that the experimental group shows an improvement of the tracheo-bronchial clearance and of the respiratory and swallowing functions. As a result, there should be fewer episodes of desaturation and HAP and less need for tracheal aspirations. In addition, patients with 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
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.
In-Exufflator Machine
Sessions using the In-Exufflator machine to improve the cough function, when the oxygen saturation decreases and the bronchial secretions increases.
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.
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;
Experimental group
The experimental group receives the same standard rehabilitative treatment performed with the control group. In addition, sessions with the EFA technology are provided.
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.
In-Exufflator Machine
Sessions using the In-Exufflator machine to improve the cough function, when the oxygen saturation decreases and the bronchial secretions increases.
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.
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;
Interventions
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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.
In-Exufflator Machine
Sessions using the In-Exufflator machine to improve the cough function, when the oxygen saturation decreases and the bronchial secretions increases.
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.
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;
Eligibility Criteria
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Inclusion Criteria
* 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
* Presence of tracheal stoma not properly healed after the removal of the tracheal cannula.
18 Years
ALL
No
Sponsors
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Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
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Principal Investigators
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Luca NC Bianchi, MD
Role: PRINCIPAL_INVESTIGATOR
IRCSS Fondazione Don Carlo Gnocchi
Locations
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Fondazione Don Carlo Gnocchi - Centro Ettore Spalenza
Rovato, BS, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Farneti D. Pooling score: an endoscopic model for evaluating severity of dysphagia. Acta Otorhinolaryngol Ital. 2008 Jun;28(3):135-40.
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.
Lanini B, Binazzi B, Romagnoli I, Chellini E, Pianigiani L, Tofani A, Molino Lova R, Corbetta L, Gigliotti F. Tracheostomy decannulation in severe acquired brain injury patients: The role of flexible bronchoscopy. Pulmonology. 2023 Dec;29 Suppl 4:S80-S85. doi: 10.1016/j.pulmoe.2021.05.006. Epub 2021 Jul 2.
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.
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 "Free Aspire" 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.
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.
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.
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.
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.
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.
Related Links
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Bargellesi Protocol
Cranial Nerve Examination for Neurogenic Dysphagia Patients-I\&I Test
Other Identifiers
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EFA-ABI
Identifier Type: -
Identifier Source: org_study_id
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