Efficacy of High Flow Nasal Cannula Versus Non- Rebreathing Mask During Endotracheal Intubation In critically ill Children : A Randomised Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Lowest saturation
研究概览
简要总结
This is a randomized clinical trial will be conducted in children 1 month to 18 years of age undergoing intubation in a pediatric intensive care .Ninety participants will be randomized to either high flow nasal cannula(HFNC) or non - rebreathing mask(NRM) for preoxygenation prior to intubation. Those randomized to the HFNC will be given heated humidified high flow nasal cannula at a rate of 2l/kg/min ( above 12 kg , add 0.5 l/kg/min with maximum flow of 50l/min ) with 100% fio2 for 4 minutes. In the NRM group, preoxygenation will be done with 15l/min flow and patients will be intubated. The aim is to compare the lowest saturation measured during endotracheal intubation from the insertion of laryngoscope to ventilator connection between patients with HFNC and NRM .These findings may contribute to the better understanding of the newer methods of pre- oxygenation .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
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 male and female patients from 1 month to 18 years requiring elective endotracheal intubation.
排除标准
- •Endotracheal intubation for cardiac arrest.
- •Emergent endotracheal intubation is indicated for conditions such as bradycardia, ventricular fibrillation, and heart block.
- •Nasopharyngeal obstruction with midline facial deformities of the jaw, nose, and larynx.
- •Children with chromosomal anomalies.
- •Children requiring reintubation.
- •Children unable to achieve saturation greater than 90% after preoxygenation for 4 minutes.
结局指标
主要结局
Lowest saturation
时间窗: Lowest oxygen saturation from the start of laryngoscopy insertion until connection to the ventilator.
次要结局
- Difficult intubation(Two failed attempts at direct laryngoscopy & one attempt will be counted as 30 seconds.)
- Time required for intubation(From the insertion of the laryngoscope to the connection to the ventilator.)
- Organ failure(During the first five days in the PICU, the assessment will be conducted using the PELOD score.)
- Complications During Endotracheal Intubation(During endotracheal intubation & the subsequent hour.)
- Time on ventilator(The duration will be calculated in days, starting from the day of intubation on the mechanical ventilator to the day of extubation.)
- Length of hospital stay(From the commencement of successful intubation to the point of hospital discharge.)
- Ventilator associated pneumonia(Achieving a score greater than 6 on the CPIS scale will result in the absolute number of patients being considered.)
研究者
Dr Anil sachdev
Sir gangaram hospital , rajinder nagar , new delhi