A Randomized Comparison of the Flex-it® Articulating Stylet to the GlideRite® Rigid Stylet for Orotracheal Intubation Using the GlideScope® in Simulated Difficult Intubations. A Double Blinded Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Intubation time
研究概览
简要总结
The purpose of this study is to determine if the Flex-it® Articulating Stylet or the GlideRite® Rigid Stylet is more effective and less traumatic in the context of difficult GlideScope® intubations.
详细描述
Pre-operatively patient are approached and enrolled according to inclusion and exclusion criteria.
Demographic data is then recorded and afterwards the patient is randomized (randomization.com) but is blinded to the group.
The patient is outfitted with a Philadelphia® cervical collar and a BIS® monitor before induction of anesthesia.
The anesthetist is blinded to the randomization group. Once asleep, the patient is intubated using the GlideScope® with the single-use blade and one of the randomized intubation stylets by an operator.
Intubation and tube manipulation times, vital signs and BIS level are recorded via a nurse or video camera.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA status 1-2
- •BMI < 35
- •Elective surgery
- •General Anesthesia
排除标准
- •Difficult intubation
- •Indication for rapid sequence intubation
- •Contraindication for cervical collar
研究组 & 干预措施
GRS (GlideRite®)
GlideScope® intubation with GRS® stylet of a simulated difficult airway
干预措施: GlideScope® intubation with GRS® stylet (Device)
FIS (Flex-it® )
GlideScope® intubation with Flex-it® stylet of a simulated difficult airway
干预措施: GlideScope® intubation with Flex-it® stylet (Device)
结局指标
主要结局
Intubation time
时间窗: During intubation
Time from start of laryngoscopy to confirmation of EtCO2
次要结局
- Sore throat/Hoarseness(Day 1 (24hr post-operative))
- Verbal Intubation difficulty scale(15 minutes after intubation)
- Tube manipulation time(During Intubation)
- Resistance during stylet extraction(15 minutes after intubation)
- Sore throat/Hoarseness(Day 0 (immediate post-operative))
研究者
John Viet Nguyen
MD
Maisonneuve-Rosemont Hospital