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Recruiting NCT07248995

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

No phase Interventional Acute Respiratory Distress Syndrome (ARDS) Acute Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stepwise Positive End-Expiratory Pressure (PEEP) Increase Protocol.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome (ARDS), Acute Brain Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Procedure Stepwise 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.

Primary outcome measures

  • Difference in PEEP Levels Between Optimal PEEP (LUS-Guided) and Safe PEEP (TCD and Respiratory Mechanics-Guided) [Time frame: From the start of the intervention until completion of the PEEP titration procedure, within approximately 120 minutes from intervention initiation.]
Secondary outcome measures (1)
  • Correlation Between PEEP Difference and Clinical Outcomes [Time frame: From the intervention until ICU discharge and hospital discharge, assessed up to 90 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Greece · 1 center
  • George Papanikolaou General Hospital — Thessaloniki

Identifiers

NCT: NCT07248995 · 10957

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗