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临床试验/NCT07716787
NCT07716787招募中不适用

Assessment of Brain Function Changes During PEEP-Based Respiratory Therapy in Critically Ill Patients Using Multimodal Neurophysiological Monitoring

Shengli Oilfield Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Change in EEG Delta Power Ratio During PEEP-Based Respiratory Interventions

研究概览

简要总结

Mechanical ventilation is commonly used in critically ill patients with acute brain injury. Positive end-expiratory pressure (PEEP) and lung recruitment maneuvers are important ventilator strategies for improving oxygenation, but they may also influence cerebral blood flow, systemic hemodynamics, carbon dioxide levels, and brain electrical activity. The effects of PEEP-related ventilator changes on cortical function in neurocritical care patients remain insufficiently understood.

This prospective observational physiological study will evaluate changes in brain electrical activity and cerebral blood flow during clinically indicated lung recruitment maneuvers and PEEP adjustments in mechanically ventilated neurocritical care patients. Multimodal monitoring will include electroencephalography (EEG), transcranial Doppler ultrasound, invasive arterial blood pressure, end-tidal carbon dioxide, and routine clinical variables.

EEG-derived measures, including delta power ratio and related frequency-domain indicators, will be used to describe cortical activity. Cerebral blood flow velocity and low-frequency neurovascular coupling measures will be explored as secondary physiological outcomes. The study will examine whether PEEP-related changes are associated with alterations in EEG activity, cerebral blood flow, and neurovascular coupling, and whether these responses differ according to clinical status.

The results may help improve understanding of brain-lung interactions during mechanical ventilation and inform future studies on individualized ventilation strategies in neurocritical care.

详细描述

Acute brain injury is frequently accompanied by respiratory dysfunction requiring mechanical ventilation because of impaired consciousness, respiratory insufficiency, or the need for airway protection. Positive end-expiratory pressure (PEEP) and lung recruitment maneuvers (RM) are commonly applied to improve oxygenation and prevent alveolar collapse. Although these interventions are essential components of lung-protective ventilation, increases in intrathoracic pressure may influence venous return, systemic hemodynamics, cerebral perfusion, carbon dioxide homeostasis, and cerebral blood flow. Such physiological alterations may subsequently affect cortical activity and neurovascular coupling, particularly in patients with impaired cerebrovascular regulation. However, the cerebral effects of ventilator interventions remain incompletely understood in neurocritical care populations.

This prospective, single-center study is designed to investigate brain-lung interactions during mechanical ventilation in patients admitted to a neurocritical care unit. The study focuses on the dynamic relationships among ventilator settings, cerebral electrophysiological activity, cerebral hemodynamics, and systemic physiological responses during clinically indicated recruitment maneuvers and PEEP adjustments.

During routine respiratory management, participants will undergo predefined ventilator interventions consisting of recruitment maneuvers and PEEP modifications according to the study protocol. Physiological signals will be continuously recorded throughout baseline, intervention, and recovery periods. This design allows assessment of cerebral responses to controlled changes in intrathoracic pressure and respiratory support while minimizing interference with standard clinical care.

Multimodal physiological monitoring will be performed simultaneously throughout the study period. Monitoring modalities include scalp electroencephalography (EEG), transcranial Doppler ultrasonography (TCD), invasive arterial blood pressure monitoring, end-tidal carbon dioxide monitoring, pulse oximetry, and routine intensive care monitoring. Physiological signals from multiple monitoring devices will be synchronized and recorded using a dedicated multimodal data acquisition platform. High-resolution recordings of cerebral electrophysiological activity, cerebral blood flow velocity, arterial blood pressure, respiratory parameters, and end-tidal carbon dioxide will allow assessment of rapid physiological responses occurring during ventilator interventions. Continuous acquisition of synchronized physiological signals will permit integrated evaluation of respiratory, cardiovascular, and cerebral responses.

EEG recordings will be analyzed using quantitative electrophysiological methods to characterize cortical activity. Spectral analysis will be performed to assess changes across conventional frequency bands, including relative delta activity and other power-based indices reflecting alterations in cortical functional state. Cerebral blood flow dynamics will be evaluated using TCD-derived cerebral blood flow velocity measurements. Simultaneous recordings of arterial blood pressure and end-tidal carbon dioxide will provide complementary information regarding cerebral perfusion and respiratory physiology.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

入选标准

  • Age ≥18 years.
  • Admission to the neurocritical care unit with acute brain injury requiring intensive care management.
  • Receiving invasive mechanical ventilation.
  • Undergoing clinically indicated recruitment maneuvers and positive end-expiratory pressure (PEEP) adjustments.
  • Availability of an adequate temporal acoustic window for transcranial Doppler monitoring.
  • Written informed consent obtained from the participant or a legally authorized representative.

排除标准

  • Pregnancy.
  • Hemodynamic instability precluding recruitment maneuvers or PEEP adjustments.
  • Severe cardiac dysfunction judged by the treating physician to contraindicate study procedures.
  • Inability to obtain adequate transcranial Doppler signals.
  • Conditions preventing EEG monitoring, including extensive scalp injury or dressings that preclude electrode placement.
  • Withdrawal of informed consent.

结局指标

主要结局

Change in EEG Delta Power Ratio During PEEP-Based Respiratory Interventions

时间窗: During ventilator interventions (baseline, intervention, and recovery periods; approximately 30 minutes)

Change in electroencephalography (EEG)-derived delta power ratio (DPR) measured before, during, and after recruitment maneuvers and positive end-expiratory pressure (PEEP) adjustments. DPR is calculated as the proportion of delta-band power relative to total EEG power and is used as an indicator of cortical electrophysiological activity.

次要结局

  • Change in Cerebral Blood Flow Velocity(During ventilator interventions (approximately 30 minutes))
  • Change in Neurovascular Coupling Index(During ventilator interventions (approximately 30 minutes))
  • Change in Mean Arterial Pressure(During ventilator interventions (approximately 30 minutes))

研究者

发起方
Shengli Oilfield Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

min xu

Director, Neurocritical Care Unit; Chief Physician

Shengli Oilfield Hospital

研究点 (1)

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