NCT01669863已完成1 期
Awake Extracorporeal Membrane Oxygenation (ECMO) for Acute Respiratory Failure A Non-controlled, Single-center, Investigator-initiated Prove-of-concept Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of Participants That Did Not Require Endotrachael Intubation
研究概览
简要总结
Proof-of-concept study addressing the feasibility of awake ECMO (v/v) in patients with acute respiratory failure
详细描述
Pilot study in 6 patients with ARDS addressing the use of awake veno-venous ECMO to avoid endotracheal intubation and mechanical ventilation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-75 yrs with acute respiratory failure due to ARDS or pneumonia fulfilling standard criteria for endotracheal intubation
- •Severe and progressive hypoxemia, i.e. PaO2 < 60 mmHg or SaO2 < 90% on O2 > 10 l/min not tolerating noninvasive ventilation, or
- •PaO2/FiO2 < 200 not improving or deteriorating on noninvasive ventilation, or
- •Respiratory distress and hypoxemia not fulfilling the criteria above with clinical impression of the ICU attending that intubation and mechanical ventilation are mandated
- •Patient considered eligible by at least two investigators of this study
排除标准
- •Patient does not fulfill the inclusion criteria
- •Uncontrolled malignancy
- •Severe and untreatable coagulation or bleeding disorders (INR > 2,0; aPTT > 60s, Platelet count < 50.000/µl, all after substitution)
- •Stroke within the past 3 months
- •Uncontrolled sepsis or septic shock
- •Multiorgan failure involving > 2 organ systems
- •Norepinephrine dose > 1 mg/h
- •Hyperdynamic circulation, indicated by cardiac index > 4.0 l/min/m2 (measured by PiCCO or Swan-Ganz catheter), or SvO2 > 80%
- •Cardiac pump failure, indicated by echocardiography (EF < 40%), PiCCO or Swan Ganz catheter (CI < 2,5 l/min/m2 despite adequate volume management), or SvO2 < 50% (provided Hb > 9,0 g/dl and SaO2 > 90%), or the need for inotropes (dobutamine, epinephrine, levosimendan)
- •Clinical or echocardiographic signs of pulmonary hypertension with right ventricular dysfunction
- •APACHE-II score15 < 25
- •Other conditions suggesting that the patient would benefit from intubation and mechanical ventilation
- •Severe neurological disorders
- •Estimated mortality due to severity of acute and/or underlying illness > 50%
结局指标
主要结局
Number of Participants That Did Not Require Endotrachael Intubation
时间窗: Duration of ICU stay
- N=6 patients will be enrolled in this exploratory pilot trial; if endotracheal intubation can be avoided in 2 or more of these patients, the trial will be considered positive. In that case, the next step would be a larger trial to better define the patient population with the highest likelihood of responding to this new therapeutic concept.
次要结局
- Number of Participants Who Presented With ECMO-Related Complications(Duration of ICU stay)
研究者
Marius Hoeper, MD
Principle Investigator
Hannover Medical School
研究点 (2)
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