NCT04352725Unknown不适用
Effect of Positive End Expiratory Pressure Titration on the End-expiratory Lung Volume Measured by the Nitrogen Dilution Technique in Acute Respiratory Distress Syndrome
Centre Hospitalier Intercommunal Aix-Pertuis2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Observe end-expiratory lung volume change during an increasing PEEP titration procedure in patients with moderate to severe ARDS
研究概览
简要总结
Mechanical ventilation of the patient with acute respiratory distress syndrome is one of the first therapies.
详细描述
The application of positive end expiratory pressure is recommended but the question remains "How to set the best positive end-expiratory pressure (PEEP) level for each patient? ". Different titration techniques have been studied on oxygenation and respiratory mechanics parameters without reaching a consensus. Currently we have a module that is connected to the ventilator to collect the patient's lung volume. It will therefore allow us to optimize the settings of the ventilator and to set the best level of positive end-expiratory pressure "best peep" in order to individualize our treatment for each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Patients admitted to intensive care with a diagnosis of moderate to severe ARDS in accordance with the Berlin criteria, i.e. a PAFI <200 and PEEP >5cm H20 ratio
- •Diagnosis of ARDS made within 72 hours
- •Age over 18 years
- •Informed consent of the patient and/or trusted person where applicable
排除标准
- •Start of mechanical ventilation more than 72 hours prior to inclusion.
- •SDRA evolving for more than 72 hours
- •Presence of major hemodynamic instability with mean blood pressure <60mmhg, and/or heart rate <45 bpm or >150bpm with an increase in vasopressor amine dosage of more than 20% over the last 6 hours.
- •Intracranial hypertension with CPP<60mmhg
- •Massive hemoptysis requiring immediate surgical or interventional radiology procedure
- •Tracheal surgery (except intensive care tracheotomy) or sternotomy within the previous 15 days
- •Trauma or surgery of the face in the previous 15 days.
- •Deep vein thrombosis treated for less than 2 days
- •Pacemaker implantation in the last 2 days
- •Unstable fracture (spine, femur or pelvis)
- •Respiratory reasons
- •use of extracorporeal oxygenation
- •nitric oxide
- •pleural drainage system with bronchopleural gap
- •pulmonary transplantation
- •Poor respiratory tolerance per procedure with desaturation Spo2<85%.
- •Poor hemodynamic tolerability per procedure combining hypotension with MAP<65mmhg and a 20% increase in norepinephrine dosage.
- •Lack of patient consent to proceed
- •minor patient
- •lack of consent
结局指标
主要结局
Observe end-expiratory lung volume change during an increasing PEEP titration procedure in patients with moderate to severe ARDS
时间窗: 1 day
次要结局
- Define a threshold of end-expiratory lung volume variation to help determine optimal PEEP(1 day)
- Analyzing the effect of PEEP titration on static compliance and dynamic strain(1 day)
- Effect of PEEP titration on hematosis via the calculation of the Pao2/Fio2 ratio for each PEEP step thanks to the measurement of Pao2 on arterial gasometry(1 day)
- Study the correlation between % change in end-expiratory lung volume and improvement in hematosis (Pao2/Fio2)(1 day)
- Compare end-expiratory lung volume variations according to the type of ARDS (severity, focal or diffuse, pulmonary or extra-pulmonary etiology)(1 day)
- Evaluate the hemodynamic tolerance of this procedure with the mean arterial pressure obtained by invasive blood pressure, noradrenaline dosage variation per procedure, lactate (obtained by arterial blood gas)(1 day)
研究者
Laurent LEFEBVRE
Doctor, rescuer
Centre Hospitalier Intercommunal Aix-Pertuis
研究点 (2)
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