Health TrialsbyHealthPanel

Efficacy of EFA in Acquired Brain Injury

ConditionsAcquired Brain InjuryComparative Effectiveness ResearchLung Diseases, Obstructive
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • Traditional respiratory treatment

    Other intervention

    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

    Other intervention

    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;

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 3 interventions
Group B: Experimental groupExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Change of oxyhemoglobin desaturation episodes

Change in the the frequency 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

Secondary outcomes

1

Reduction of tracheal cannula aspiration

Reduction of the number of the needed aspiration in the tracheal cannula due to tracheo-bronchial obstruction

Time frame
During the data collection in the 8 weeks of treatment for each patient, the number of tracheal cannula aspiration will be registered.
2

Number of patient that develop hospital-acquired pneumonia

Variation in the number of cases of 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
3

Change of tracheostomy weaning time

Change of time need to accomplish tracheostomy weaning, measured in days

Time frame
From baseline to last observation (at the of 8 weeks treatment)
4

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).

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Don Carlo Gnocchi Onlus

Lead sponsor

Source ClinicalTrials.gov
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