Actively Recruiting
The Contribution of the Combination of Transthoracic and Transcranial Ultrasonography to the Titration of Positive End-expiratory Pressure in Patients With Acute Respiratory Distress Syndrome and Acute Brain Injury
Led by Theodoros Schizodimos · Updated on 2025-12-31
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether combining lung and brain ultrasonography helps select the best positive end-expiratory pressure (PEEP) for critically ill patients who are mechanically ventilated with acute respiratory distress syndrome (ARDS) and acute brain injury (ABI). The study focuses on creating an individualized ventilation strategy that protects the brain while managing lung function. This is important because improving lung aeration may affect brain pressure and blood flow. Participants will undergo a stepwise increase of PEEP at four levels: 5, 8, 12, and 16 cmH2O. After each increase, lung ultrasound will assess lung aeration patterns using the Lung Ultrasound Score, and transcranial Doppler ultrasonography will evaluate cerebral blood flow and intracranial pressure indicators. Researchers will record intracranial pressure, brain oxygen levels, respiratory mechanics, and arterial blood gases during the approximately 120-minute procedure. During the study, each participant serves as their own control. Researchers will monitor lung and brain function continuously to find the optimal PEEP level that balances lung and brain needs. They will measure differences in PEEP levels guided by lung and brain ultrasound, and follow clinical outcomes up to 90 days after intervention. The study includes safety monitoring and detailed assessments to develop a brain-protective ventilation approach for these critically ill patients.
CONDITIONS
Brief Title
Contribution of Transthoracic and Transcranial Ultrasonography to the Titration of PEEP in Patients With ARDS and ABI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Severe acute brain injury such as traumatic brain injury, subarachnoid hemorrhage, intracerebral hemorrhage, or acute ischemic stroke
- Development of acute respiratory distress syndrome (ARDS) according to Berlin criteria within 10 days of ICU admission
You will not qualify if you...
- Severe chronic brain diseases
- Brain tumor or central nervous system infection
- Severe chronic pulmonary or cardiovascular disease
- Severe coagulopathy
- Undergoing decompressive craniectomy
- Lack of invasive neuromonitoring
- Withdrawal of life-sustaining treatment
- Poor acoustic window in ultrasound
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 hours
Participants undergo a stepwise increase of positive end-expiratory pressure (PEEP) at four levels. After each change, lung ultrasound and transcranial doppler assessments are performed along with recording of intracranial pressure, brain oxygen partial pressure, and mechanical ventilation parameters. Arterial blood gases are taken 20 minutes after each PEEP adjustment.
1 intensive treatment session
Duration - Up to 90 days
Participants are monitored for clinical outcomes related to PEEP differences until ICU and hospital discharge, up to 90 days.
Visits as part of routine ICU and hospital care
Trial Site Locations
Total: 1 location
1
George Papanikolaou General Hospital
Thessaloniki, Greece, 54248
Actively Recruiting
Research Team
T
Theodoros Schizodimos, MD
G
Georgia Pitsiou, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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