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临床试验/NCT05675696
NCT05675696撤回不适用

Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation

NYU Langone Health2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
60
试验地点
2
主要终点
Transpulmonary Driving Pressure

研究概览

简要总结

The present study will utilize esophageal manometry to measure the presence and magnitude of persistent patient effort during lung protective ventilation, allowing identification and mitigation of occult lung stress.

研究设计

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

  • Intubated with a diagnosis of ARDS and expected to be ventilated for ≥ 48 hours
  • Meets Berlin criteria for ARDS, with or without underlying chronic lung disease
  • Triggering breaths on the ventilator
  • Treating medical team agrees with patient participation

排除标准

  • Known or suspected esophageal abnormalities, craniofacial abnormalities, or upper GI bleed
  • Shock that requires ≥ 2 vasopressors
  • pH on arterial blood gas ≤7.25
  • Minute ventilation ≥ 14L/min
  • Known or suspected pneumothorax, pneumomediastinum, and/or subcutaneous emphysema
  • Severe ARDS with P/F ratio <60
  • Pregnancy
  • Currently receiving extracorporeal membrane oxygenation (ECMO) therapy
  • Decision to withhold life-sustaining treatment
  • Patients who are not expected to survive for 24 hours
  • Lack of informed consent

结局指标

主要结局

Transpulmonary Driving Pressure

时间窗: Up to Hour 2 (Day 1)

Transpulmonary driving pressure is the pressure difference between the airway opening and pleural surface. It represents lung stress and is higher with increased spontaneous respiration and work of breathing.

Driving Pressure

时间窗: Up to Hour 2 (Day 1)

Driving pressure is defined as plateau pressure minus positive end-expiratory pressure (PEEP). Driving pressure during mechanical ventilation is directly related to stress forces in the lung.

Work of Breathing (WOB)

时间窗: Up to Hour 2 (Day 1)

WOB is the amount of energy or oxygen (O2) consumption needed by the respiratory muscles to produce enough ventilation and respiration to meet the metabolic demands of the body.

Pressure-Time Product (PTP)

时间窗: Up to Hour 2 (Day 1)

PTP is the product of the average inspiratory pressure (starting from the onset of effort) and the duration of inspiration. The PTP was developed to account for energy expenditures during the dynamic and isometric phases of respiration.

次要结局

  • Lung Compliance (C, l)(Up to Hour 2 (Day 1))
  • Respiratory System Compliance (C, rs)(Up to Hour 2 (Day 1))
  • Chest Wall Compliance (C, cw)(Up to Hour 2 (Day 1))
  • Oxygen Saturation(Up to Hour 2 (Day 1))
  • PaO2/FiO2 (P/F) Ratio(Up to Hour 2 (Day 1))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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