Incidence Of Unplanned Extubation In Nasotracheal vs Orotracheal Intubation In a Paediatric Intensive Care Unit : An Open Labelled Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- To compare unplanned extubation rates between nasotracheal intubation group and orotracheal intubation group
研究概览
简要总结
Unplanned extubation defined as the unintended removal of an endotracheal tube by a patient, is a significant clinical challenge in pediatric intensive care units (PICUs). It can lead to serious consequences such as hypoxemia, airway trauma, increased need for sedation, emergency reintubation, prolonged mechanical ventilation, and extended PICU stays. These complications not only pose clinical risks but also increase healthcare costs and resource utilization.This study seeks to address this gap by comparing the incidence of unplanned extubation between nasotracheal and orotracheal intubation in children admitted to the PICU, aiming to inform clinical decision-making and improve patient outcomes.
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
- 3.00 Month(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 3 month to 14 years admitted in PICU, intubated at any point of time during the PICU stay.
排除标准
- •Known bleeding disorder, Raised intracranial pressure, Already tracheostomized patient, Structural malformation,Nasal trauma, Already intubatedmore than 24 hours at the time of admission to PICU, Consent denial.
结局指标
主要结局
To compare unplanned extubation rates between nasotracheal intubation group and orotracheal intubation group
时间窗: 72 hours after successful extubation
次要结局
- Number of attempts required for successful intubation in both groups(not applicable)
- Complications during intubation(10 minutes post intubation)
- Incidence of post extubation stridor in both groups(72 hours post extubation)
- Duration of ventilated days in both groups(48 hours after removing ventilator support)
- Incidence of Ventilator associated pneumonia between the two groups(Not applicable)
研究者
Dr AMLAN JAIN
AIIMS RAIPUR