Efficacy of EFA in Acquired Brain Injury

NCT05993364 | Recruiting

• 1 other identifier: EFA-ABI
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Acquired brain injury (ABI) is one of the biggest cause of death and disability in the world. Patients with ABI often have difficulties with swallow and breath. The study purpose is to evaluate if the Expiratory Flow Accelerator (EFA) technology has positive effects on the respiratory and swallowing function in patients with acquired brain injury (ABI). Researchers recruit patients at Centro Ettore Spalenza-Fondazione Don Carlo Gnocchi in Rovato, Italy. To partecipate, patients should satisfy certain eligibility criteria; they will not be enrolled if they satisfy exclusion criteria. If a patient can be recruited, researchers conduct the baseline assessment lasting 1 one week. After that, the patient will be randomized to the study or control group. If the patient is in the control group, he will receive a traditional rehabilitation treatment. Otherwise, the patient will receive an additional treatment with the EFA device. Researchers will assess again the patient (with the same procedures of baseline assessment) after 8 weeks of treatment. They want to see if the EFA device could help patients with ABI to improve their health conditions.

Conditions

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

Keywords

Expiratory Flow Accelerator; Tracheobronchial secretions; Tracheobronchial clearance; Airways clearance; Pulmonary infections; Pulmonary obstruction; Decannulation; Tracheal cannula; Effectiveness; Acquired Brain Injury; Controlled study

Outcome Measures

Primary Outcomes (1)

• Change of oxyhemoglobin desaturation episodes

  Change in the the frequency of oxyhemoglobin desaturation episodes.

  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

  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

  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

  From baseline to last observation (at the of 8 weeks treatment)

• Staff satisfaction

  From baseline to last observation (at the of 8 weeks treatment)

Study Arms (2)

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.

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.

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

Interventions

Free Aspire with Expiratory Flow Accelerator (EFA) technology DEVICE

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.

Experimental group

In-Exufflator Machine DEVICE

Sessions using the In-Exufflator machine to improve the cough function, when the oxygen saturation decreases and the bronchial secretions increases.

Control group; Experimental group

Traditional respiratory treatment OTHER

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.

Control group; Experimental group

Traditional swallowing treatment OTHER

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;

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Carlo Gnocchi - Centro Ettore Spalenza

Rovato, BS, 25038, Italy

RECRUITING

Related Publications (16)

• 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.

  PMID: 28515545 BACKGROUND

• 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.

  PMID: 31390146 BACKGROUND

• 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.

  PMID: 29268199 BACKGROUND

• 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.

  PMID: 4834725 BACKGROUND

• 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.

  PMID: 19033220 BACKGROUND

• 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.

  PMID: 31320355 BACKGROUND

• Farneti D. Pooling score: an endoscopic model for evaluating severity of dysphagia. Acta Otorhinolaryngol Ital. 2008 Jun;28(3):135-40.

  PMID: 18646575 BACKGROUND

• 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.

  PMID: 31713573 BACKGROUND

• 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.

  PMID: 34219041 BACKGROUND

• 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.

  PMID: 33591464 BACKGROUND

• 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.

  PMID: 31390330 BACKGROUND

• 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.

  PMID: 33039853 BACKGROUND

• 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.

  PMID: 8721066 BACKGROUND

• 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.

  PMID: 33563372 BACKGROUND

• 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.

  PMID: 3271655 BACKGROUND

• 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.

  PMID: 17510594 BACKGROUND

Related Links

• Bargellesi Protocol
• Cranial Nerve Examination for Neurogenic Dysphagia Patients-I\&I Test

MeSH Terms

Conditions

Brain Injuries; Lung Diseases, Obstructive; Airway Obstruction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Lung Diseases; Respiratory Tract Diseases; Respiratory Insufficiency; Respiration Disorders

Study Officials

• Luca NC Bianchi, MD

  IRCSS Fondazione Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riccardo NC Buraschi, PT

CONTACT

+390307245282; rburaschi@dongocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 15, 2023
• Study Start: February 19, 2024
• Primary Completion: February 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)