Comparison of Flex-It Stylet to Malleable Stylet for GlideScope Intubation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time to Intubation
研究概览
简要总结
Patients presenting for elective surgery requiring tracheal intubation will be randomized to one of two different ETT stylets. The primary outcome is time to intubation.
The null hypothesis is that there will be no difference.
The GlideScope video laryngoscope (Verathon) is a widely used intubating device that uses a high-resolution camera embedded into a plastic laryngoscope blade. An LED provides illumination. The GlideScope often provides a good laryngoscopic view, but passing the endotracheal tube (ETT) through the vocal cords is sometimes difficult. Because of the 60 degree anterior curvature of the GlideScope's blade, ETT's must have stylets inserted so that the ETT distal tip can be positioned anteriorly. Various authors have recommended different angles of the ETT to optimally place it into the trachea, including matching the GlideScope's 60 degree angle, or configuring the ETT with a 90 degree bend. Previous studies demonstrated that 90 degree sharp bend was both faster and subjectively easier in a heterogeneous group of intubators. With the introduction of the Flex-It stylet by Parker Medical, the question arises as to the the best configuration of stylet for the ETT. Therefore, this prospective, randomized, single-blinded trial is proposed.
详细描述
Written informed consent will be obtained by one of the study investigators, and a copy will be given to each participant. Written informed consent will also be obtained from the operator of the GlideScope. Envelopes with computer-generated randomized group assignments will be present at each site. The envelopes will be consecutively numbered (i.e. "U1", "U2" for University Hospital, "S1", "S2" for St Joseph's Health Care, etc.). After consent, randomization will occur by selecting the next consecutive envelope. The envelope will contain the data collection form as well as a piece of paper that has the following information:
- at the top will be the randomization group (A, B) and a text description of the endotracheal tube angle and stylet (i.e. "90 degrees - malleable stylet")
- in the body of the piece of paper will be a template that shows the exact shape into which the tube must be bent, including where the distal and proximal ends are, the angle of curvature that must be followed, and the location along the length of the tube at which to create this angle. The angle and location will be the same for both males and females.
There are three distinct anesthesia providers involved in the conduct of this study, as follows:
- "operator" - person performing the intubation
- "timer" - person timing the outcome (one of the co-investigators)
- "shaper" - person who ensures that the angle and stylet of the tube matches the group to which the patient was allocated
Because the person intubating must be blind up until the time at which the tube is to be used, the unopened envelope will be taken to a third anesthesia provider, who will prepare the ETT with stylet in an area that is not visible to the person performing the intubation or to the person timing the intubation. The person performing the intubation will specify what size of tube to be prepared. This will most commonly be 7.5 mm internal diameter (ID) for a female and 8.0 ID for males, but the operator is free to use whatever size they feel is appropriate. The tube size selection will take place before unblinding so the group allocation cannot affect the decision of tube size.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Any adult patient scheduled for elective surgery.
- •ETT is indicated for the procedure in the opinion of the attending anesthesiologist.
- •Any operator who has performed ≥ 10 GlideScope intubations.
排除标准
- •Any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.
- •* Patient with known cervical spine abnormalities.
- •* Any patients with known or probable difficult airways (this rare occurrence is unlikely to be evenly distributed between the groups and could skew the data).
- •Any patient requiring rapid sequence induction.
结局指标
主要结局
Time to Intubation
时间窗: Prospective 10-150 seconds
次要结局
- Ease of Intubation Visual Analog Scale(Prospective)