The Videolaryngoscopy in Small Infants (VISI) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 566
- 试验地点
- 9
- 主要终点
- Number of Participants With Success in the First Attempt
研究概览
简要总结
Complications related to infant (≤ 1 year) airway management are under-appreciated because of few rigorous and targeted studies. Investigators have recently shown that multiple tracheal intubation (TI) attempts are a key risk factor for intubation-related complications in small children. Tracheal Intubation using Video laryngoscopy (VL) has become popular in anesthesiology practice because of several advantages over conventional direct laryngoscopy (DL). Studies show that VL improves the view of the airway compared to DL, requires fewer intubation attempts, but may take more time to intubate the trachea. This study compares first attempt success of VL to DL in infants presenting for elective surgery.
详细描述
Objectives:
- Primary Objective To compare the tracheal intubation (TI) first attempt success rate using VL vs. DL in children ≤ 12 months old.
- Secondary Objectives To compare the lowest oxygen saturation during tracheal intubation with VL vs. DL.
Study Design:
Prospective, randomized, multi-center parallel group trial
Setting/Participants:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statistician will be blinded at the time of data analysis.
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Success in the First Attempt
时间窗: at the time of intubation
comparing the tracheal intubation (TI) first attempt success rate using VL vs. DL
次要结局
- Hypoxia(At the time of intubation)