Clinical trial NCT05993364: Efficacy of EFA in Acquired Brain Injury
Official title: Role of Expiratory Flow Acceleration in the Management of Bronchial Secrections in Severe Acquired Brain Injury: a Pilot Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of oxyhemoglobin desaturation episodes
timeFrame: During the data collection in the 8 weeks of treatment for each patient, the number of oxyhemoglobin desaturation episodes will be registered
Secondary outcomes:
measure: Reduction of tracheal cannula aspiration
timeFrame: During the data collection in the 8 weeks of treatment for each patient, the number of tracheal cannula aspiration will be registered.
measure: Number of patient that develop hospital-acquired pneumonia
timeFrame: 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
measure: Change of tracheostomy weaning time
timeFrame: From baseline to last observation (at the of 8 weeks treatment)
measure: Staff satisfaction
timeFrame: From baseline to last observation (at the of 8 weeks treatment)
Other outcomes:
Locations:
city: Rovato
country: Italy
facility: Fondazione Don Carlo Gnocchi - Centro Ettore Spalenza
state: BS
Study officials:
affiliation: IRCSS Fondazione Don Carlo Gnocchi
name: Luca NC Bianchi, MD
role: PRINCIPAL_INVESTIGATOR
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