George Papanikolaou General Hospital
Thessaloniki, 54248, Greece
Location status: Recruiting
NCT Number: NCT07248995
The present study will investigate whether the combined use of lung and brain ultrasonography is useful in selecting the optimal positive end-expiratory pressure in mechanically ventilated critically ill patients with acute respiratory distress syndrome and acute brain injury, aiming at an individualized, brain-protective ventilation strategy.
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All sexes
Interventional
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Thessaloniki, 54248, Greece
Location status: Recruiting
The present study aims to evaluate whether the combined use of lung ultrasonography and brain ultrasonography can assist in determining the optimal positive end-expiratory pressure (PEEP) in mechanically ventilated, critically ill patients with acute respiratory distress syndrome (ARDS) and acute brain injury (ABI). In patients with concomitant respiratory and neurological injury, selecting an appropriate PEEP level is particularly challenging, as strategies that improve lung aeration may simultaneously increase intracranial pressure or compromise cerebral hemodynamics.
Lung ultrasound will be used to assess aeration patterns and guide lung recruitment through the Lung Ultrasound Score (LUS), while transcranial Doppler ultrasonography will be used to evaluate cerebral blood flow and intracranial pressure surrogates, such as the pulsatility index. By integrating both assessments, the study seeks to identify a PEEP level that optimizes pulmonary function while minimizing adverse effects on cerebral physiology. The overarching goal is to develop an individualized, brain-protective ventilation strategy for patients with ARDS and ABI.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention includes a stepwise increase in PEEP level from 5 to 8, 12 and 16 centimeter of water (cmH2O). After each PEEP level change, lung ultrasound and transcranial doppler will be performed, and the values of intracranial pressure (ICP) and brain oxygen partial pressure (PO2), as well as the mechanical ventilation parameters, will be recorded. Arterial blood gases will be taken 20 minutes later.
Time frame: From the start of the intervention until completion of the PEEP titration procedure, within approximately 120 minutes from intervention initiation.
Optimal PEEP is determined using the Lung Ultrasound Score (LUS; aeration score 0-36), while Safe PEEP is determined based on Transcranial Doppler (TCD) measurements (Pulsatility Index, mean flow velocity) and respiratory mechanics parameters (driving pressure, plateau pressure, compliance). The outcome represents the difference between Optimal PEEP and Safe PEEP expressed in cmH₂O.
Unit of Measure: cmH₂O
Time frame: From the intervention until ICU discharge and hospital discharge, assessed up to 90 days
Correlation between the difference in PEEP levels (cmH₂O) and the following clinical outcomes: duration of mechanical ventilation, ICU length of stay, and ICU/hospital mortality.
Unit of Measure:
PEEP difference: cmH₂O, Duration of mechanical ventilation: days, ICU length of stay: days, ICU mortality: %, Hospital mortality: %
Contact information is provided by the study sponsor or research team.
Georgia Pitsiou, PhD
CONTACT
Theodoros Schizodimos, MD
CONTACT
Theodoros Schizodimos
Other
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
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