Traumatic Brain Injury and Neuropsychiatric Complications.
Saeed Ahmed, Hema Venigalla, Hema Madhuri Mekala...
https://pubmed.ncbi.nlm.nih.gov/28515545Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05993364
Role of Expiratory Flow Acceleration in the Management of Bronchial Secretions in Severe Acquired Brain Injury: a Pilot Randomized Controlled Study
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2024-08-09
20
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Acquired Brain Injury (ABI) is a leading cause of death and disability worldwide, often causing difficulties with swallowing and breathing. This research investigates whether the Expiratory Flow Accelerator (EFA) device can improve respiratory and swallowing functions in patients with ABI. The study is conducted at Centro Ettore Spalenza-Fondazione Don Carlo Gnocchi in Rovato, Italy, aiming to reduce complications like hospital-acquired pneumonia and improve tracheotomy weaning. Patients first undergo a one-week baseline assessment measuring oxygen saturation, oxygen supply, desaturation episodes, tracheal cannula aspirations, and antibiotic treatments for pneumonia. After this, they are randomly assigned to either a control group receiving standard rehabilitation treatments or an experimental group receiving the same rehabilitation plus additional sessions with the EFA device. The EFA treatment occurs three times daily Monday to Friday and once on Saturday, each lasting 20 minutes, using the device via tracheal cannula, facial mask, or mouthpiece. Participants are monitored throughout the 8-week treatment period with weekly arterial blood gas analyses and repeated assessments of the baseline measures. Researchers focus on the number of oxyhemoglobin desaturation episodes as the primary outcome, along with secondary measures like tracheal aspiration frequency, pneumonia incidence, tracheostomy weaning time, and staff satisfaction. The study aims to assess if EFA improves airway clearance and respiratory health in ABI patients.
CONDITIONS
Brief Title
Efficacy of EFA in Acquired Brain Injury
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age higher than 18 years old
- Hospitalized after diagnosis of acquired brain injury (traumatic or vascular)
- Levels of Cognitive Functioning Scale (LCFS) score between 1 and 5
- Presence of spontaneous breathing at least during the day
You will not qualify if you...
- Need for mechanical ventilation for more than 12 hours a day
- Presence of tracheal stoma not properly healed after removal of the tracheal cannula
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Assessment
Duration - 1 week
Participants undergo daily assessments of respiratory and swallowing parameters to establish baseline measurements before treatment begins.
Daily assessments during the week
Treatment
Duration - 8 weeks
Participants receive rehabilitative treatments to improve secretion management and respiratory function. The control group receives standard respiratory and swallowing therapy daily. The experimental group receives the same treatments plus sessions using the Free Aspire device with Expiratory Flow Accelerator (EFA) technology multiple times per day.
Daily sessions Monday to Saturday; control group has 30 to 60 minute sessions once daily; experimental group has additional EFA sessions three times daily Monday to Friday and once on Saturday
Trial Site Locations
Total: 1 location
1
Fondazione Don Carlo Gnocchi - Centro Ettore Spalenza
Rovato, BS, Italy, 25038
Actively Recruiting
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Research Team
R
Riccardo NC Buraschi, PT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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