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临床试验/NCT07248995
NCT07248995招募中不适用

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

Theodoros Schizodimos1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Difference in PEEP Levels Between Optimal PEEP (LUS-Guided) and Safe PEEP (TCD and Respiratory Mechanics-Guided)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Stepwise PEEP Elevation Protocol Arm

Experimental

All participants with ARDS and ABI will undergo a protocolized stepwise increase of PEEP at four levels. Each participant will serve as their own control.

干预措施: Stepwise Positive End-Expiratory Pressure (PEEP) Increase Protocol (Procedure)

结局指标

主要结局

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

时间窗: 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

次要结局

  • Correlation Between PEEP Difference and Clinical Outcomes(From the intervention until ICU discharge and hospital discharge, assessed up to 90 days)

研究者

发起方
Theodoros Schizodimos
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Theodoros Schizodimos

Theodoros Schizodimos

George Papanicolaou Hospital

研究点 (1)

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