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Contribution of Transthoracic and Transcranial Ultrasonography to the Titration of PEEP in Patients With ARDS and ABI

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07248995
Enrollment
30
Registered
2025-11-25
Start date
2025-12-01
Completion date
2027-07-31
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Brain Injury, Acute Respiratory Distress Syndrome (ARDS)

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREStepwise Positive End-Expiratory Pressure (PEEP) Increase Protocol

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.

Sponsors

Theodoros Schizodimos
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years * Severe acute brain injury (e.g., traumatic brain injury, subarachnoid hemorrhage, intracerebral hemorrhage, acute ischemic stroke) * Development of ARDS (according to Berlin criteria) within the first 10 days of ICU admission

Exclusion criteria

* Severe chronic brain diseases * Brain tumor or central nervous system (CNS) 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

Design outcomes

Primary

MeasureTime frameDescription
Difference in PEEP Levels Between Optimal PEEP (LUS-Guided) and Safe PEEP (TCD and Respiratory Mechanics-Guided)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

Secondary

MeasureTime frameDescription
Correlation Between PEEP Difference and Clinical OutcomesFrom the intervention until ICU discharge and hospital discharge, assessed up to 90 daysCorrelation 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: %

Countries

Greece

Contacts

Primary ContactTheodoros Schizodimos, MD
teoschizo@gmail.com+306973439717
Backup ContactGeorgia Pitsiou, PhD
gpitsiou@yahoo.gr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026