Prospective observational study to find association of DP and mechanical power measured in first 36-hours of intubation with 28-day ventilator-free days in a heterogeneous group of mechanically ventilated children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Driving pressure and Mechanical Power measured in first 36-hours of intubation with 28-day ventilator-free days in a heterogeneous group of mechanically ventilated children
研究概览
简要总结
• Children included in the study shall be ventilated on PC mode and sedated as per unit policy.
• Consent shall be taken
• Paralysis will be as per unit policy and treating clinician’s discretion
• The PEEP setting shall be as per the underlying lung condition and treating consultant’s discretion.
• Setting of Tidal Volume (Vt), PIP, Respiratory Rate (RR), Inspiratory Time (Ti) etc will eb as per the Pediatric Mechanical Ventilation Consensus Conference (PEMVECC)6 guidelines and for pARDS patients as per the PALICC guidelines.
• The mechanical ventilators used will be GE CARESCAPE R860. Software version 10 (infant Pediatric and adult), Manufacturer: Datex Ohmeda Inc. Made in USA. And MAQUET (GETINGE Group) SERVO-i v8.0 (infant and Pediatric) (Manufacturer. Maquet critical care AB. Sweden).
• In both GE CARESCAPE R860 and MAQUET Servo-I and Servo-S ventilators, circuit compliance, resistance and leak are measured and compensated each time at the initiation of the ventilation. In both the ventilators the inspiratory tidal volume (VTi) is measured by the inspiratory sensor and displayed on the screen of the ventilators. In both the ventilators the inspiratory flow sensors are automatically zeroed each time when the ventilator is started.
• Also, whenever possible, using the E –sCOVX module, End Expiratory Lung (EELV) Volume and Functional Residual Capacity (FRC) estimation will be done and strain shall be calculated at 12 hrs and 24-36 hours of ventilation.
In our unit all the ventilators undergo preventive maintenance and calibrations once every year as per the manufacturer recommendations
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients intubated for respiratory failure and ventilated on Pressure-control mode of ventilation shall be included in the study from 1-month age till 18-years age.
排除标准
- •Children with neuromuscular diseases,
- •Those who got extubated within 24-hours of intubation.
- •Those who needed HFOV or ECMO within first 36 hours of admission
- •Those who got intubated and ventilated in outside hospitals for more than 12 hours
- •Children with immunodeficiency
- •Post operative children following Liver or Renal Transplants.
结局指标
主要结局
Driving pressure and Mechanical Power measured in first 36-hours of intubation with 28-day ventilator-free days in a heterogeneous group of mechanically ventilated children
时间窗: Driving pressure and Mechanical Power measured in first 36-hours of intubation with 28-day ventilator-free days.
次要结局
- calculate Mechanical Power Normalized to body weight (NorMP) and Mechanical Energy and their association with 28-days ventilator free days.(Association with other outcome parameters like PICU length of stay and mortality will be studied.)