Feasibility of a Combined Use of a Video-laryngoscope With a Novel Video-stylet for Predicted Difficult Intubation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Intubation Time
研究概览
简要总结
We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with general anesthesia including endotracheal intubation. Patients qualify for the trial if they are considered a difficult airway case as determined by measurement of common predictive indices for difficult intubation (see inclusion criteria). All patients will be intubated with a GVL. Patients will be randomly assigned to either having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). The randomization will be stratified as to whether patients are categorized as predicted difficult airway or have an immobilized cervical spine (C-collar in place).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 35
- •Thyromental distance < 6 cm
- •Sterno-mental distance < 12 cm
- •Mallampati grade 3 and 4
- •Interincisor distance < 38 mm
- •Status of dentition: presence of buckteeth
- •Neck movement < 35°
- •Neck circumference >43 cm at the level of the thyroid cartilage
- •Patients with immobilized cervical spine (C-collar in place).
- •History of difficult laryngoscopy or intubation
排除标准
- •Full stomach
- •Hiatal hernia
- •Severe GERD (Gastroesophageal reflux disease)
- •Tumors of the upper airway
研究组 & 干预措施
Control
Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
干预措施: Control (Device)
Intervention
Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
干预措施: aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD) (Device)
结局指标
主要结局
Intubation Time
时间窗: 120 seconds
divided into time to successfully place the glidescope (visualization of the epiglottis), time to successfully insert the videostylet (passing through the cords) and time to verified placement of the ETT (as outlined above). Interim bag and mask time, if needed, will not be included in the intubation time. More than 5 attempts or 120 s are regarded as failure of intubation. If failure to secure the airway occurs with the GVL and videostylet, then conventional difficult intubation protocols approved by the University of Louisville Hospital will be implemented.
次要结局
- Laryngeal View Grade of 1 or 2(30 minutes)
- Ease of Intubation(2-4 hours after intubation)
- The Number of Intubation Attempts(30 minutes)
- Neck Movement(30 minutes)
研究者
Rainer Lenhardt
Professor
University of Louisville