Assessment of pressure responsiveness with Eadyn using passive leg raise in adult patient with sepsis - A Prospective Observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- To evaluate the ability of Eadyn-guided dynamic assessment in predicting pressure responsiveness with passive leg raise among critically ill adults with sepsis.
研究概览
简要总结
CO,SBP, DBP, MAP) and HR will be continuously monitored.Baseline stroke volume, Baseline SVR will be assessed. HemoSphere monitor calculates PPV, SVV, and SV every 20 seconds. Eadyn will be calculated from the PPV over SVV ratio. Central venous pressure will be monitored throughout study. Baseline vasoactive inotropic score(VIS ) will be calculated.Passive leg raising as well as the volume expansion will be done. Vasopressors and ventilator settings will not be changed at any time while a patient is being studied. The hemodynamic parameters of SV, PPV, SVV, CI, CO, Eadyn and SVR will be measured from the continuous cardiac output monitor. There will be a simultaneous SV measurement done with TTE.
Step 1: The patient will be placed in a semi-recumbent position with the head elevated at 45 degrees and the haemodynamic parameters will be noted.
Step 2: The patient will be positioned supine with the legs straight and elevated at 45 degrees for 90s. The haemodynamic parameters will be noted at 90-120s after giving this position.
Step 3: Returned to the baseline position.
As a part of standard of care, the patients with change in stroke volume >15% are categorized as fluid responders, and receive a volume expansion with 250ml of crystalloids over 10 minutes15.
Step 4: Assess the haemodynamic parameters after 2minutes of volume expansion.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults with preserved spontaneous respiratory efforts aged between 18 to 65 years with sepsis requiring vasopressor therapy to maintain MAP of more than or equal 65 mmHg after initial resuscitation or capillary refill time more than 3 seconds or lactate levels more than 2mmol per litre or urine output less than 0.5ml per kg per hr for at least 2hours.
- •Sequential organ failure assessment score more than
- •Patients with arterial catheter and central venous line in situ.
排除标准
- •Pregnancy Patients with Arrhythmias, increased intracranial hypertension, head trauma, pain or agitation Right heart failure, defined here as evidence of abnormal RV structure or function with clinical signs of right heart failure, including edema in both legs, hepatomegaly With suspected increased intra-abdominal pressure Ongoing neuromuscular blockade Vasoactive Inotropic Score(VIS) 20 With peripheral vascular disease Burns involving extremities.
结局指标
主要结局
To evaluate the ability of Eadyn-guided dynamic assessment in predicting pressure responsiveness with passive leg raise among critically ill adults with sepsis.
时间窗: on admission to critical care unit
次要结局
- To correlate the Eadyn derived from cardiac output monitor alone and the Eadyn derived with echocardiography and cardiac output monitor in responders and non-responders.
- To compare velocity time integral (VTI) response to PLR and continuous cardiac output monitor stroke volume response between the responders and non-responders(on admission to critical care unit)