HemodynamIc eFfects of Lung Collapse and overdIstension in Patients With Moderate-to-seVEre Acute Respiratory Distress Syndrome: the HI-FIVE Physiologic Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Impact of lung collapse on cardiac output
研究概览
简要总结
The management ARDS relies on ventilatory strategies aimed at limiting ventilator-induced lung injury (VILI). The setting of PEEP is still subject of debate, as randomized clinical trials comparing standardized higher versus lower PEEP strategies failed to demonstrate a clear survival advantage. Only few studies explored the hemodynamic effects of various PEEP levels depending on lung recruitability. Furthermore, the role of PEEP-mediated lung collapse and overdistention on patients' hemodynamics has yet to be elucidated. In this physiologic study, the association between EIT-measured lung collapse and overdistention and cardiac function will be explored, accounting for the individual potential for lung recruitment, partitioned respiratory mechanics and cardiac preload responsiveness. Three PEEP levels will be tested in a randomized, crossover fashion: PEEP corresponding to the crossing point between lung collapse and overdistention, PEEP associated with low lung collapse, PEEP associated with low lung overdistention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •acute respiratory failure with onset < 1 week from a predisposing risk factor, such as pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock;
- •bilateral opacities on chest radiography and computed tomography or bilateral B lines and/or consolidations on lung ultrasound not fully explained by effusions, atelectasis, or nodules/masses;
- •pulmonary edema not exclusively or primarily attributable to cardiogenic pulmonary edema/fluid overload, and hypoxemia/gas exchange abnormalities not primarily attributable to atelectasis;
- •PaO2/FiO2 ratio ≤ 200 during invasive controlled mechanical ventilation;
排除标准
- •age <18 years;
- •pregnancy;
- •signs of barotrauma or documented pneumothorax;
- •severe tachycardia (HR > 120 bpm) and severe lacticaemia (lac > 4 mmol/L)
- •pre-existing decompensated heart failure (NYHA class 3-4 and/or documented left ventricular ejection fraction < 35%);
- •contraindications to EIT placing (open chest wounds, presence of cardiac pacemaker);
- •intubation as a result of an acute exacerbation of chronic pulmonary disease;
- •contraindications to esophageal balloon placement (high bleeding risk, esophageal varices).
研究组 & 干预措施
Low lung overdistention PEEP
干预措施: Change in PEEP (Other)
Lung collapse and overdistention crossing point PEEP
干预措施: Change in PEEP (Other)
Low lung collapse PEEP
干预措施: Change in PEEP (Other)
结局指标
主要结局
Impact of lung collapse on cardiac output
时间窗: Assesment performed at the end of each of the three 30 minute steps
Evaluation of the relative contribution of lung collapse (arbitrary units) on patients' cardiac output at different PEEP levels (L/min)
Impact of lung collapse on pulmonary vascular resistance
时间窗: Assesment performed at the end of each of the three 30 minute steps
Evaluation of the relative contribution of lung collapse (arbitrary units) on pulmonary vascular resistance (dyn·s/cm\^5) at different PEEP levels
Impact of lung overdistention on cardiac output
时间窗: Assesment performed at the end of each of the three 30 minute steps
Evaluation of the relative contribution of lung overdistention (arbitrary units) on patients' cardiac output at different PEEP levels (L/min)
Impact of lung overdistention on pulmonary vascular resistance
时间窗: Assesment performed at the end of each of the three 30 minute steps
Evaluation of the relative contribution of lung overdistention (arbitrary units) on pulmonary vascular resistance (dyn·s/cm\^5) at different PEEP levels
次要结局
- Correlation between potential for lung recruitment and PEEP-induced changes in cardiac output(Assessment at the end of each of the three 30 minute steps)
- Correlation between potential for lung recruitment and PEEP-induced changes in pulmonary vascular resistance(Assesment performed at the end of each of the three 30 minute steps)
- PEEP-induced effects on cardiac output in cardiac preload responsive vs. nonresponsive patients(Assesment performed at the end of each of the three 30 minute steps)
- PEEP-induced effects on pulmonary vascular resistance in cardiac preload responsive vs. nonresponsive patients(Assesment performed at the end of each of the three 30 minute steps)
- Relationship between transpulmonary pressures and central venous pressure variations(At the end of each of the three 30 minute steps)
- Lung hysteresis(At the end of each of the three 30 minute steps)
- Lung aeration distribution(At the end of each of the three 30 minute steps)
- Relationship between PEEP-induced changes in lung volume and PEEP-induced changes in pulmonary vascular resistance(Assesment performed at the end of each of the three 30 minute steps)
- Relationship between PEEP-induced changes in lung volume and PEEP-induced changes in cardiac output(Assesment performed at the end of each of the three 30 minute steps)
研究者
GRIECO DOMENICO LUCA
Medical Doctor, Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS