The Strategy of "Pulmonary Opening by Titration of Positive End-expiratory Pressure" Means of a Pulmonary Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome: for Which Patients?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 8
- 主要终点
- oxygenation and pulmonary compliance
研究概览
简要总结
Pulmonary recruitment maneuvers open these lung areas and appropriate adjustment of positive expiratory pressure (PEP) helps to stabilize recruitment and reduce the stress associated with alveolar opening and closing. Its beneficial effects in the lung affected by Acute Respiratory Distress Syndrome (ARDS) remain unclear. The hypothesis is that there is a heterogeneous effect of the recruitment maneuver according to the phenotype of ARDS. It is important to be able to define responder patients from non-responders to this recruiting maneuver.
详细描述
It will be a prospective interventional study in resuscitation patients with severe or moderate ARDS. This study will be multicentric between the University Hospital of Amiens and intensive care of Lens, intensive care of Bethune and intensive care of Arras. All patients in intensive care and severe, moderate ARDS will be included in this study. All patients will benefit from Lung ultrasound (LUS) with a mapping of each lung looking for normal or pathological lung profiles, as well as a measurement of esophageal pressure (Peso) at rest. A "PEP titration pulmonary opening" (PEP-OP) test using a recruitment maneuver was then performed in all patients followed by a new LUS and Peso measurement.
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
- 否
入选标准
- •Will be included in the study, patients:
- •Major patient (age ≥18 years)
- •Controlled assisted ventilation, sedation and curarization adapted to the respirator.
- •Within the first 72 hours of an ARDS (PaO2 / FiO2 ≤ 200 mmHg, FiO2 ≥ 60% and PEEP of ≥5 cmH20) (as recommended by the Berlin criteria)
- •Decision of intensivist in charge of the patient to put an oesophageal probe
- •After hemodynamic optimization (evaluation of the preload dependence and need for catecholamines)
- •Decision of the intensivist in charge of the patient to perform a pulmonary opening test by titration of PEEP by means of a pulmonary recruitment test.
排除标准
- •Patients under the age of 18
- •Pregnant women, women who are parturient or breastfeeding
- •Patients with pulmonary broncho-emphysematous pathology or at risk of presenting it.
- •Patients with a history of barotrauma or at risk of presenting it.
- •Patients with a history of intracranial hypertension
- •Patients with suspected or proven right ventricular dysfunction or uncontrolled hemodynamic instability after hemodynamic management.
- •Patients with a contraindication to the placement of an oesophageal tube (esophageal surgery, severe esophageal pathology)
- •Patients under guardianship or curatorship or deprived of liberty.
- •Patients who are legally protected
- •Patient not covered by French national health insurance
结局指标
主要结局
oxygenation and pulmonary compliance
时间窗: at 1 hours of the PEP-OP test.
The primary outcome is oxygenation (PaO2 / FiO2) and pulmonary compliance ((Pplat-Pep) / VT) at 1h of the PEP-OP test.
次要结局
- Oxygenation (PaO2 / FiO2) at 6h, 12h, 24h(at 6 hours, 12 hours, 24 hours of the PEP-OP test)
- Hospitalization in intensive care time(Discharge from intensive care unit)
- Incidence of barotrauma(After PEP-OP)
- Mechanical ventilation time(Discharge from intensive care unit)
- The need for recourse to alternative therapies of oxygenation(Discharge from intensive care unit)
- Pulmonary compliance at 6 hours, 12 hours and 24 hours(at 6 hours, 12 hours and 24 hours of the PEP-OP test.)