Time-controlled Adaptive Ventilation (TCAV) Compared With Conventional Ventilation in Patients With Moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) Secondary to Community-acquired Pneumonia (EARLY-TCAV)
Efficacy and Safety of Time-controlled Adaptive Ventilation (TCAV) Compared With Conventional Ventilation in Patients Requiring Invasive Ventilation for Moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) Secondary to Community-acquired Pneumonia
ARDS is a pathology with mortality rates reaching 40%. Invasive ventilation, the cornerstone of ARDS management, leads to "ventilation-induced lung injury" (VILI). An approach based on pressure-controlled ventilation with unassisted spontaneous respirations (PC-SV or APRV) can limit the occurrence of VILI. Time-controlled adaptive ventilation (TCAV) is based on high mean inspiratory airway pressure, while limiting expiratory time at low pressure. TCAV has shown positive effects in experimental and observational studies. However, its efficacy and safety in patients with moderate-to-severe ARDS remains to be evaluated.
Evaluation of the efficacy of early application of TCAV compared to standard ventilation on the severity of alveolar damage leading to injury-related pulmonary edema in patients with moderate to severe ARDS After obtaining patient's consent, eligible patients will be included in this open-label, randomized controlled pilot study with stratification by minimization based on initial severity. The experimental group will be the TCAV group, where ventilator settings will be standardized. The ventilator in the standard care group will be set to volumetric mode with positive end-expiratory pressure according to the EXPRESS protocol.
The measurement of extravascular lung water will be compared on day 2 between the TCAV settings group and the standard care settings group using the PICCO system.
The TCAV setting is simple and inexpensive. In ARDS patients, the increase in injury-related pulmonary edema is a relevant marker of mortality, and its reduction could improve patients' outcomes. Our study aims to evaluate the efficacy and safety of these settings to justify a future large-scale, multicenter randomized trial.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Matthieu KOSZUTSKI, MD
- 电话号码：+33 3 83 15 30 17
- 邮箱：m.koszutski@chru-nancy.fr
学习地点
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Nancy、法国、54000
- CHRU de Nancy
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接触：
- Matthieu KOSZUTSKI, MD
- 电话号码：+33 3 3 83 15 30 17
- 邮箱：m.koszutski@chru-nancy.fr
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-
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
描述
Inclusion Criteria:
- Intensive care unit hospitalisation for ARDS with a PaO₂/FiO₂ ratio ≤ 200 mmHg and PEEP ≥ 5 cmH₂O under invasive ventilation
- Criteria for community-acquired pneumonia, 2 of the following: cough, purulent sputum, chest pain, dyspnea
- Onset of symptoms ≤ 7 days
- Invasive ventilation initiated ≤ 24 hours
- Affiliation to a social security program
- Patient for whom written consent has been obtained from a trusted person or a family member, or inclusion in a situation of immediate life-threatening emergency
Exclusion Criteria:
- Focal ARDS defined as unilateral involvement (1 out of 4 quadrants or 2 on the same side) on imaging (chest X-ray or CT scan)
- Right heart failure not related to acute pulmonary heart disease secondary to ARDS (pulmonary embolism, myocarditis, ischemic cause)
- Pneumothorax, drained or undrained, with a persistent pleural air leak
- COPD with significant obstructive impairment defined by the presence of chronic respiratory disease and oxygen therapy or non-invasive ventilation at home
- Circulatory support via VV-ECMO or VA-ECMO
- Presence of a patent foramen ovale
- Active limitation of therapies
- Increased intracranial pressure
- Sickle cell disease
- Burns > 30%
- Expected invasive mechanical ventilation for less than 48 hours
- A person covered by Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code
- Pregnant or breastfeeding women
- A not emancipated minor
- Adults subject to legal protective measures (guardianship, conservatorship, judicial protection) or inability to give consent
- Persons deprived of liberty by a judicial or administrative decision, persons receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Time-controlled Adaptative Ventilation
Invasive ventilation with the ventilator set on the Airway Pressure Release Ventilation mode.
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Invasive ventilation with the ventilator set on the Airway Pressure Release Ventilation mode as follows:
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有源比较器：Volume Control
Invasive ventilation with the ventilator set on the Volume control mode.
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Invasive ventilation with the ventilator set on the Volume control mode as follows:
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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 |
|---|---|---|
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Extravascular Lung Water (EVLW)
大体时间：48 hours
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Measured with transpulmonary thermodilution (TPTD) and expressed in ml per kilogram of body weight
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48 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mortality
大体时间：60 days
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Occurrence of death
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60 days
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Ventilator-free days
大体时间：day 30
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Number of days without invasive or non-invasive ventilation
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day 30
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Major Adverse Kidney Events (MAKE)
大体时间：Day 7, Day 30
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Need of dialysis, decrease ≥ 25% of glomerular filtration rate and all cause-death
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Day 7, Day 30
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Adverse Events
大体时间：Day 30
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Defined as:
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Day 30
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Pressure difference
大体时间：day 1, day 2, day 3, day 4
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in cmH20
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day 1, day 2, day 3, day 4
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Extravascular Lung Water Indexed to the predicted body weight (EVLWIp)
大体时间：48 hours
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Measured with transpulmonary thermodilution (TPTD) and expressed in ml per kilogram of predicted body weight
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48 hours
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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
更多信息
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