Acquired Brain InjuryNCT05993364
Efficacy of EFA in Acquired Brain Injury
A study testing Free Aspire with Expiratory Flow Accelerator (EFA) technology, In-Exufflator Machine and Traditional respiratory treatment in people with Acquired Brain Injury and Comparative Effectiveness Research, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury, Comparative Effectiveness Research, Lung Diseases, Obstructive
- What is being tested?
- Free Aspire with Expiratory Flow Accelerator (EFA) technology, In-Exufflator Machine and Traditional respiratory treatment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 19 Feb 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Don Carlo Gnocchi - Centro Ettore Spalenza
Rovato, BS, 25038
Riccardo Buraschi, 00390307245 ext. 282, rburaschi@dongnocchi.it
About this study
Official title: Role of Expiratory Flow Acceleration in the Management of Bronchial Secrections in Severe Acquired Brain Injury: a Pilot Randomized Controlled Study
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.
Read more
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.
Read the detailed description
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 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.
- Being tested
- Free Aspire with Expiratory Flow Accelerator (EFA) technology, In-Exufflator Machine, Traditional respiratory treatment, Traditional swallowing treatment
- Keywords
- Expiratory Flow Accelerator, Tracheobronchial secretions, Tracheobronchial clearance, Airways clearance, Pulmonary infections, Pulmonary obstruction, Decannulation, Tracheal cannula, Effectiveness, Acquired Brain Injury, Controlled study
- Medical subject headings
- Brain Injuries, Lung Diseases, Obstructive, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free Aspire with Expiratory Flow Accelerator (EFA) technologyDevice
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 MachineDevice
Sessions using the In-Exufflator machine to improve the cough function, when the oxygen saturation decreases and the bronchial secretions increases.
Traditional respiratory treatmentOther
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 treatmentOther
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;
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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. Receives: Device: In-Exufflator Machine; Other: Traditional respiratory treatment; Other: Traditional swallowing treatment |
| Experimental group | Experimental | The experimental group receives the same standard rehabilitative treatment performed with the control group. In addition, sessions with the EFA technology are provided. Receives: Device: Free Aspire with Expiratory Flow Accelerator (EFA) technology; Device: In-Exufflator Machine; Other: Traditional respiratory treatment; Other: Traditional swallowing treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of oxyhemoglobin desaturation episodes
Change in the the frequency of oxyhemoglobin desaturation episodes.
Measured: During the data collection in the 8 weeks of treatment for each patient, the number of oxyhemoglobin desaturation episodes will be registered
Secondary outcomes (4)
Reduction of tracheal cannula aspiration
Reduction of the number of the needed aspiration in the tracheal cannula due to tracheo-bronchial obstruction
Measured: During the data collection in the 8 weeks of treatment for each patient, the number of tracheal cannula aspiration will be registered.
Number of patient that develop hospital-acquired pneumonia
Variation in the number of cases of hospital-acquired pneumonia.
Measured: During the data collection in the 8 weeks of treatment for each patient, the number of hospital-acquired pneumonia that require an antibiotic treatment will be registered
Change of tracheostomy weaning time
Change of time need to accomplish tracheostomy weaning, measured in days
Measured: From baseline to last observation (at the of 8 weeks treatment)
Staff satisfaction
A 5 point Likert scale will be administered to rehabilitation staff about the ease of use of the EFA device and the time expenditure. Score from 0 (minimum value) to 4 (maximum value).
Measured: From baseline to last observation (at the of 8 weeks treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start19 Feb 2024
- Primary completionFeb 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca NC Bianchi, MD, Principal investigator, IRCSS Fondazione Don Carlo Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993364
- Sponsor's protocol ID
- EFA-ABI
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28515545Belli 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.
PubMed 31390146Borders 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.
PubMed 29268199Bone 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.
PubMed 4834725Cook 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.
PubMed 19033220Eskildsen 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.
PubMed 31320355Farneti D. Pooling score: an endoscopic model for evaluating severity of dysphagia. Acta Otorhinolaryngol Ital. 2008 Jun;28(3):135-40.
PubMed 18646575Galeoto 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.
PubMed 31713573Lanini 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.
PubMed 34219041Ninfa 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.
PubMed 33591464Patrizio 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.
PubMed 31390330Riboldazzi 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.
PubMed 33039853Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.
PubMed 8721066Rotolo 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.
PubMed 33563372Thomas-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.
PubMed 3271655
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Expiratory Flow Acceleration in the Management of Bronchial Secrections in Severe Acquired Brain Injury: a Pilot Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05993364
- Acronym / sponsor ID
- EFA-ABI
- Keywords
- Expiratory Flow Accelerator, Tracheobronchial secretions, Tracheobronchial clearance, Airways clearance, Pulmonary infections, Pulmonary obstruction, Decannulation, Tracheal cannula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: In-Exufflator Machine, Other: Traditional respiratory treatment, Other: Traditional swallowing treatmentThe 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. |
| Experimental group | Experimental | Device: Free Aspire with Expiratory Flow Accelerator (EFA) technology, Device: In-Exufflator Machine, Other: Traditional respiratory treatment, Other: Traditional swallowing treatmentThe experimental group receives the same standard rehabilitative treatment performed with the control group. In addition, sessions with the EFA technology are provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free Aspire with Expiratory Flow Accelerator (EFA) technologyTreatment 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 | Experimental group |
| In-Exufflator MachineSessions using the In-Exufflator machine to improve the cough function, when the oxygen saturation decreases and the bronchial secretions increases. | Device | Control group, Experimental group |
| Traditional respiratory treatmentStandard 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 | Control group, Experimental group |
| Traditional swallowing treatmentTraditional 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; | Other | Control group, Experimental group |
Primary outcome
Change of oxyhemoglobin desaturation episodes
Time frame: During the data collection in the 8 weeks of treatment for each patient, the number of oxyhemoglobin desaturation episodes will be registered
Change in the the frequency of oxyhemoglobin desaturation episodes.
4 secondary outcomes
Reduction of tracheal cannula aspiration
Time frame: During the data collection in the 8 weeks of treatment for each patient, the number of tracheal cannula aspiration will be registered.
Number of patient that develop hospital-acquired pneumonia
Time frame: During the data collection in the 8 weeks of treatment for each patient, the number of hospital-acquired pneumonia that require an antibiotic treatment will be registered
Change of tracheostomy weaning time
Time frame: From baseline to last observation (at the of 8 weeks treatment)
Staff satisfaction
Time frame: From baseline to last observation (at the of 8 weeks treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 28515545Ahmed 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.
- Background: PubMed 31390146Belli 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.
- Background: PubMed 29268199Borders 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.
- Background: PubMed 4834725Bone 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.
- Background: PubMed 19033220Cook 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.
- Background: PubMed 31320355Eskildsen 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.
- Background: PubMed 18646575Farneti D. Pooling score: an endoscopic model for evaluating severity of dysphagia. Acta Otorhinolaryngol Ital. 2008 Jun;28(3):135-40.
- Background: PubMed 31713573Galeoto 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.
- Background: PubMed 34219041Lanini 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.
- Background: PubMed 33591464Ninfa 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.
- Background: PubMed 31390330Patrizio 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.
- Background: PubMed 33039853Riboldazzi 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.
- Bargellesi ProtocolLink provided by the sponsor.
- Cranial Nerve Examination for Neurogenic Dysphagia Patients-I\&I TestLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca NC Bianchi, MD principal investigator
IRCSS Fondazione Don Carlo Gnocchi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free Aspire with Expiratory Flow Accelerator (EFA) technology, In-Exufflator Machine and Traditional respiratory treatment in people with Acquired Brain Injury and Comparative Effectiveness Research, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Riccardo NC Buraschi, PT (+390307245282, rburaschi@dongocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of oxyhemoglobin desaturation episodes (time frame: During the data collection in the 8 weeks of treatment for each patient, the number of oxyhemoglobin desaturation episodes will be registered). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05993364, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.