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ARDS受试者的各种策略的增量和减少窥视滴定:一项前瞻性生理研究 (ARDS,PEEP)

2026年8月21日 更新者:Zhou Yongfang、West China Hospital

在电阻抗监测和评估通风和灌注分布差异的指导下,研究精确的个性化机械通气策略的精确机械通气策略

研究人员对ARDS人群进行了前瞻性的生理观察研究,描述了其生理和EIT指数各种PEEP滴定方法,还比较并分析了这些指数,以确定各种PEEP滴定方法之间是否存在差异。以不同的方式探索和发现对最佳窥视的响应的生理差异,并以这些不同的方式分析了最佳窥视的相关性。

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

31

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • West China Hospital of Sichuan University, Chengdu

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

从2022年10月至2024年7月,招募了18年内的ICU的中等重度ARD(PAO2 /FIO2,200 mm HG)的18年中的NTUB和机械通风患者。

描述

纳入标准:

  • ICU的插管和机械通风患者在48小时内
  • 年满18岁
  • 与中度重度ARDS(PAO2 /FIO2,200 mm Hg)

排除标准:

  • 严重的慢性阻塞性肺部疾病
  • 肺癌(> 1厘米)或气胸或气胸或皮下肺气肿
  • 怀孕
  • BMI≥35kg/m2
  • 怀疑的肺血管出血
  • 意识或颅内高血压的干扰
  • 严重的心脏功能障碍(纽约心脏协会III类或IV级,急性 - 冠状动脉综合征或持续性心室心律失常),心源性休克或大型心脏手术后
  • 血液动力学不稳定性(即平均动脉压[MAP] <60 mm Hg,尽管使用了加压剂
  • 医疗团队考虑短期不安全的高压
  • 放置食道压力导管的禁忌症(例如,颅底食管杂种或断裂)
  • EIT监测的禁忌症(包括起搏器或限制电极放置的皮肤疾病)
  • 疾病的激动阶段或终点

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
the selected PEEP values
大体时间:through study completion, an average of 1 year

1. Method-specific selected PEEP values

  • Description: The principal endpoint was the set of 15 method-specific selected PEEP values determined for each patient.
  • Unit of Measure: cmH₂O
through study completion, an average of 1 year

次要结果测量

结果测量
措施说明
大体时间
SpO2/FiO2 at each selected PEEP
大体时间:baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
SpO2/FiO2 measured at each selected PEEP. This study will separately measure peripheral oxygen saturation (SpO₂, unit: %) and fraction of inspired oxygen (FiO₂, unit: %). Because both measurements share the same unit (%), they will not be reported as separate outcome measures. Instead, they will be aggregated into a single reported value: the SpO₂/FiO₂ ratio (dimensionless). At each selected positive end-expiratory pressure (PEEP) level, the ratio will be calculated as S/F = SpO₂ (%) ÷ FiO₂ (%), and this ratio will be recorded as the final outcome measure.
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
respiratory system compliance value at each selected PEEP
大体时间:baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
This study will directly record the respiratory system compliance value as measured and displayed by the ventilator (unit: mL/cmH₂O) at each selected PEEP.
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
plateau pressure at each selected PEEP
大体时间:baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
At each selected positive end-expiratory pressure (PEEP) level, plateau pressure will be directly recorded from the ventilator after performing an inspiratory hold maneuver. This value is displayed by the ventilator in cmH₂O
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
Driving Pressure at each selected PEEP
大体时间:baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
At each selected positive end-expiratory pressure (PEEP) level, plateau pressure (Pplat, unit: cmH₂O) will be measured via the ventilator, and the corresponding PEEP value (unit: cmH₂O) will be recorded. Driving pressure (ΔP) is calculated as the difference between the two: ΔP = Pplat - PEEP (unit: cmH₂O).
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
End-inspiratory Transpulmonary Pressure (PTPi) at each selected PEEP
大体时间:baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
After placement of an esophageal pressure catheter, the ventilator will monitor esophageal pressure (Pes) and airway pressure. At each selected positive end-expiratory pressure (PEEP) level, an end-inspiratory hold maneuver will be performed. The end-inspiratory transpulmonary pressure (PTPi) is calculated as the difference between the airway plateau pressure (Pplat) measured during the hold and the corresponding esophageal pressure (Pes): PTPi = Pplat - Pes (unit: cmH₂O).
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
End-expiratory Transpulmonary Pressure (PTPe) at each selected PEEP
大体时间:baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
After placement of an esophageal pressure catheter, the ventilator will monitor esophageal pressure (Pes) and airway pressure. At each selected positive end-expiratory pressure (PEEP) level, an end-expiratory hold maneuver will be performed. The end-inspiratory transpulmonary pressure (PTPe) is calculated as the difference between the PEEP measured during the hold and the corresponding esophageal pressure (Pes): PTPe = PEEP - Pes (unit: cmH₂O). This calculated value is the single reported outcome measure
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
transpulmonary driving pressure at each selected PEEP
大体时间:baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
After placement of an esophageal pressure catheter, the ventilator will monitor transpulmonary pressures. At each selected PEEP level, end-inspiratory transpulmonary pressure (PTPi) and end-expiratory transpulmonary pressure (PTPe) are obtained during inspiratory and expiratory hold maneuvers, respectively. Both are measured in cmH₂O. Transpulmonary driving pressure is calculated as the difference: ΔPtp = PTPi - PTPe (unit: cmH₂O).
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
EIT-derived Regional Ventilation Parameters at each selected PEEP level
大体时间:baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
Using electrical impedance tomography (EIT), the lung is divided into four regions of interest (ROI I to ROI IV) from ventral to dorsal. For each ROI, the percentage of tidal impedance variation relative to total tidal impedance variation is recorded (% of total). unit: cmH₂O
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
the center of ventilation (COV) at each selected PEEP level
大体时间:baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
the center of ventilation (COV) is calculated as the position of the ventilation center along the ventral-dorsal axis, expressed as a percentage (0% = ventral, 100% = dorsal). this parameter is measured in %
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
CL HP% (overdistension region) at each selected PEEP level
大体时间:baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
Using electrical impedance tomography (EIT),based on regional compliance analysis,CL HP% represent the percentage of lung regions showing a decrease in compliance at high PEEP due to overdistension (unit: %).
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
CL LP% (collapse region) at selected PEEP
大体时间:baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
Using electrical impedance tomography (EIT),based on regional compliance analysis,CL LP% represent the percentage of lung regions showing a decrease in compliance at low PEEP due to collapse (unit: %).
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年12月10日

初级完成 (实际的)

2025年7月28日

研究完成 (实际的)

2025年7月28日

研究注册日期

首次提交

2024年12月5日

首先提交符合 QC 标准的

2025年1月29日

首次发布 (实际的)

2025年2月5日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月21日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • PEEP Titration
  • 2024YFFK0329 (其他赠款/资助编号:Sichuan Science and Technology Program)
  • 2024ZD0530000 (其他赠款/资助编号:Noncommunicable Chronic Diseases-National Science and Technology Major Project)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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