Efficacy of EFA in Acquired Brain Injury

January 25, 2024 updated by: Fondazione Don Carlo Gnocchi Onlus

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • BS
      • Rovato, BS, Italy, 25038
        • Fondazione Don Carlo Gnocchi - Centro Ettore Spalenza
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: In-Exufflator Machine
Sessions using the In-Exufflator machine to improve the cough function, when the oxygen saturation decreases and the bronchial secretions increases.
Other: 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.
Other: 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: 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.
Device: In-Exufflator Machine
Sessions using the In-Exufflator machine to improve the cough function, when the oxygen saturation decreases and the bronchial secretions increases.
Other: 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.
Device: 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.
Other: 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the data collection in the 8 weeks of treatment for each patient, the number of oxyhemoglobin desaturation episodes will be registered

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Reduction of the number of the needed aspiration in the tracheal cannula due to tracheo-bronchial obstruction
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
Variation in the number of cases of 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
Time Frame: From baseline to last observation (at the of 8 weeks treatment)
Change of time need to accomplish tracheostomy weaning, measured in days
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)
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).
From baseline to last observation (at the of 8 weeks treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Investigators

  • Principal Investigator: Luca NC Bianchi, MD, IRCSS Fondazione Don Carlo Gnocchi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 19, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFA-ABI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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