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临床试验/NCT07564258
NCT07564258尚未招募不适用

Estimation of Airway Occlusion Pressure at 100 ms Using Ultrasound Indexes of Diaphragm Function

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 40 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
P0.1 and Peak contraction velocity 5 minutes after the initiation of the SBT

研究概览

简要总结

Occlusion pressure at 100 ms (P0.1) is a reliable and non-invasive index of inspiratory drive that can be measured easily on most ventilator. Unfortunately, P0.1 cannot be measured reliably in non-intubated patients. In those receiving non-invasive ventilation, the measurement of P0.1 might be inaccurate due to leaks. P0.1 cannot be measured at all in patients receiving high-flow nasal canulae (HFNC).

Ultrasound indices of diaphragm contractile function, namely diaphragm excursion, velocity and thickening fraction, could be reliable and non-invasive proxies of respiratory drive in non-intubated patient.

Our hypothesis is that ultrasound indices of diaphragm function may reliably estimate P0.1. To validate this hypothesis, theses indices will be measured simultaneously with P0.1 in intubated patients, during diaphragm loading conditions similar to spontaneous breathing: the spontaneous breathing trial (SBT). The SBT is used to evaluate if patients can breathe without the assistance provided by the ventilator, and thus, be weaned from mechanical ventilation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 old
  • Patient intubated or tracheostomized
  • Decision by the clinician in charge to initiate a SBT
  • After information, the patient or next of kind did not refuse to participate (according to the French law, written informed consent is waived)

排除标准

  • - Suspicion of diaphragmatic nerves injury
  • Preexisting neuromuscular disease
  • Spinal cord injury above C5
  • Neuromuscular blockade within last 24 hours
  • Body mass index > 40 kg/m2
  • Pregnancy or breast feeding
  • Patient under legal protection

结局指标

主要结局

P0.1 and Peak contraction velocity 5 minutes after the initiation of the SBT

时间窗: 5 minutes after the initiation of the SBT

Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to peak contraction velocity of the diaphragm, measured by subcostal ultrasound in TDI-mode

次要结局

  • P0.1 and EXdi(Immediately after the initiation of the SBT then 5, 10, 15, 20, 25 and 30 minutes after the initiation of the SBT)
  • P0.1 and Peak contraction velocity(Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT)
  • P0.1 and EXdi,0.1(Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT)
  • P0.1 and Velocity Time Integral(Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT)
  • P0.1 and Peak relaxation velocity(Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT)
  • P0.1 and Peak relaxation rate(Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT)
  • P0.1 and TFdi(Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT)
  • P0.1 and mean thickening velocity(Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT)

研究者

申办方类型
Other
责任方
Sponsor

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