Estimation of P0.1 Using Ultrasound Indexes of Diaphragm Function (PoccUS)
Estimation of Airway Occlusion Pressure at 100 ms Using Ultrasound Indexes of Diaphragm Function
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.
研究概览
研究类型
注册 (估计的)
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- - 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)
Exclusion Criteria:
- - 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
学习计划
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 |
|---|---|---|
|
P0.1 and Peak contraction velocity 5 minutes after the initiation of the SBT
大体时间：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
|
5 minutes after the initiation of the SBT
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
P0.1 and EXdi
大体时间：Immediately after the initiation of the SBT then 5, 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to maximal excursion of the diaphragm, measured by subcostal ultrasound in M-mode
|
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
大体时间：Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 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
|
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
大体时间：Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to excursion of the diaphragm measured 100 ms after the beginning of the inspiration, measured by subcostal ultrasound in M-mode
|
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
大体时间：Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to velocity time integral of the diaphragm, measured by subcostal ultrasound in TDI-mode
|
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
大体时间：Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to peak relaxation velocity of the diaphragm, measured by subcostal ultrasound in TDI-mode
|
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
大体时间：Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to peak relaxation rate of the diaphragm, measured by subcostal ultrasound in TDI-mode
|
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
大体时间：Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to thickening fraction of the diaphragm, measured by intercostal ultrasound in M-mode.
|
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
大体时间：Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to mean thickening velocity of the diaphragm, measured by intercostal ultrasound in M-mode.
|
Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
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