Ultra-protective Pulmonary Ventilation Supported by Low Flow Extracorporeal Carbon Dioxide Removal (ECCO2R) and Prone Positioning for ARDS; a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Plateau Pressure
研究概览
简要总结
This study evaluates the use of ultra-protective ventilation, where very low ventilation volumes are used, in patients with severe acute respiratory distress syndrome (ARDS) meeting criteria to nurse in the prone position. Half the patients will receive ultra-protective ventilation support by extracorporeal carbon dioxide removal, while the other half will receive conventional lung protective ventilation.
详细描述
Current best practices for management of severe ARDS include lung protective ventilation and nursing in the prone position. However, the best lung protective strategy is not currently established and using smaller ventilation volumes than standard lung protective ventilation suggest lung recovery is improved.
Application of smaller ventilation volumes requires extracorporeal carbon dioxide removal, using a device similar to a dialysis to remove carbon dioxide directly from the blood. One such device in the Prismalung, it removes blood through a catheter, much like a dialysis catheter, pumps it through a gas exchange cartridge which removes carbon dioxide. The gas exchange cartridge functions in a similar way to a dialysis filter, except it allow gases to pass through, unlike dialysis filters which allow passage of fluid and small molecules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data analysis will be blinded.
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to MICU with respiratory failure and intubated
- •ARDS criteria per Berlin definition
- •PaO2:FiO2 ratio ≤ 200 mmHg for > 6 hours with FiO2 ≥0.5
- •Expected to require mechanical ventilation for >48 hours
- •Reversible disease
排除标准
- •Anticoagulation contraindicated
- •Proven HIT
- •Unable to obtain central venous access
- •Refractory hypoxia (PaO2:FiO2 ≤80 after recruitment and proning) or other indication for ECMO
- •Home oxygen use
- •Severe COPD
- •Interstitial lung disease
- •> 7 days of mechanical ventilation
- •Immunocompromised patient (bone marrow, untreated HIV, PJP)
- •Advanced malignancy with life expectancy ≤ 6months
结局指标
主要结局
Plateau Pressure
时间窗: Duration of ventilation for severe ARDS, expected average time 10 days
Ability to achieve a plateau pressure of \</=25 cmH20 in the intervention arm
次要结局
- Length of hospital stay(Duration of patient stay in hospital)
- Cardiac Imaging(One data set per patient during first 72 hours)
- Ability to successfully prone(Duration of ICU stay)
- Enrolment rates(First 48 hours)
- Mortality(Monitored for 3 months)
- Extracorporeal carbon dioxide removal related complications(Duration of severe ARDS, expected average time frame 10 days)
- Ventilator free days(28 days)
- Ventilation parameters(Duration of mechanical ventilation)
- Ventilator associated pneumonia rates(Duration of ICU stay)
- Number of patient meeting proning criteria in each group(Duration of ICU stay)
- Lung recruitability(Duration of ICU stay)
- Length of stay in ICU stay(Duration of patient stay in ICU, expected average stay 2 weeks)
- Biomarkers of Pulmonary Inflammation(Day 0, 4 and 7)
- All severe adverse events(Duration of ICU stay (anticipate average stay 1-2 weeks))
- Incidence of dialysis in ICU, and ability to successfully initiate(Duration of ICU stay)
- Incidence of referrals for ECMO(Duration of ICU stay)
- Rate and reasons for declining consent to study participation(First 48 hours)
- Barotrauma complications(Duration of ICU stay)
研究者
Matthew COVE
Matthew COVE
National University Health System, Singapore