Comparison of Pulse Pressure Variation, Inferior Vena Cava Distensibility Index, Hemodynamics and Changes in Hemodynamics in Response to Mini Fluid Challenge as Predictor of Fluid Responsiveness.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate the predictive power of Pulse Pressure Variation (PPV) and the Distensibility Index of the Inferior Vena Cava (DIVC) in predicting fluid responsiveness in mechanically ventilated patients with undifferentiated shock.
研究概览
简要总结
This prospective observational cohort study will be conducted in the critical care department at Holy Family Hospital, New Delhi, on patients over 18 years of age with Shock undergoing Mechanical Ventilation. This study aims to compare the effectiveness of hemodynamic parameters, pulse pressure variation (PPV) and inferior venacava distensibility index (dIVC) in predicting fluid responsiveness in mechanically ventilated patients with undifferentiated shock. After obtaining ethics approval and written informed consent, eligible patients will be enrolled. Patients will be sedated, paralyzed, and mechanically ventilated with a tidal volume of 8mL per kg predicted body weight, maintaining a semi-recumbent position.
Baseline hemodynamic parameters (PPV, heart rate, blood pressure, CVP) will be recorded using invasive arterial waveform monitoring. dIVC will be measured via ultrasound at the IVC-hepatic vein junction, and left ventricular outflow tract velocity time integral (LVOT VTI) will be assessed via echocardiography. Observations will be conducted by trained, blinded observers.
A Fluid challenge (4mL/kg) will be administered, and changes in hemodynamic parameters and LVOT VTI will be recorded immediately and 2 minutes post-infusion. Patients will be classified as fluid responders (more than or equal to 10% increase in LVOT VTI) or non-responders (less than 10% increase). Observers will remain blinded throughout the study to minimize bias and variability. Maintenance fluids and treatment will be managed by the treating physician,
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •More than or equal to 18 years of age on mechanical ventilation admitted in ICU
- •Clinical signs of shock, defined as any of the following: a.MAP less than 65mmHg b.Requiring vasopressors support to maintain MAP more than 65mmHg c.Lactate more than 2mmol per L d.Oliguria less than 0.5ml per kg per hour urine output e.Capillary refill time more than 5sec.
排除标准
- •1.Cardiac arrythmias 2.Moderate to severe valvular dysfunction 3.Poor echo window 4.Increased intraabdominal pressure 5.Large intra-abdominal masses or ascites causing IVC compression.
- •6.Right heart failure, acute Cor pulmonale 7.Patient not giving consent to get included in study.
- •8.Spontaneous breathing efforts (interferes with heart-lung interaction).
- •9.Severe obstructive airway diseases (e.g., COPD exacerbation, asthma with active bronchospasm).
结局指标
主要结局
To evaluate the predictive power of Pulse Pressure Variation (PPV) and the Distensibility Index of the Inferior Vena Cava (DIVC) in predicting fluid responsiveness in mechanically ventilated patients with undifferentiated shock.
时间窗: Before and after completion of fluid bolus.
次要结局
- To compare the predictive power of PPV and DIVC as dynamic parameters for prediction of fluid responsiveness among responders and non-responders.(Pre fluid challenge)
- To analyze the changes in hemodynamic parameters after a fluid challenge and their association with fluid responsiveness(pre and post fluid challenge)
- To assess the predictive performance of PPV and DIVC across subgroups, such as:(1.Septic vs. non-septic shock patients.)
- To determine the impact of baseline clinical and hemodynamic variables, such as central venous pressure (CVP) and baseline vasopressor support, on fluid responsiveness.(prefluid challenge)
- To validate the reliability of PPV and DIVC under varying clinical conditions, such as different driving pressures and PEEP levels, through subgroup analyses.(prefluid challenge)
研究者
Dr Ruchi Gupta
Holy Family Hospital