Method Evaluation Study of Truview PCD Versus MacIntosh Laryngoscope
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Cormack Lehane (CL) grade
研究概览
简要总结
Aim:
The aim of the method evaluation study is a comparing study of Truview PCD™ (Picture Capture Device) laryngoscope vs. Macintosh laryngoscope. The result of this study will form a basis for a possible recommendation of the Truview PCD™ laryngoscope in our organisation.
The laryngoscopes are compared according to their ability to visualize the glottis area measured by the Cormack Lehane (CL) grade and the time used to get the best CL grade.
A registration of any damage of tissue/teeths caused by the laryngoscopes, and a possible decrease of the saturation will also be made.
Hypothesis:
The Truview PCD™ laryngoscope provides a better view of the vocal cords and thereby makes the intubation les difficult.
CL 1 is achieved in 90 percent of intubations with the Macintosh laryngoscope, and the hypothesis of the study is that CL 1 can be increased to 98 percent by use of the Truview PCD™ laryngoscope.
详细描述
The unexpected difficult intubation is, like the difficult mask ventilation, a feared complication to anaesthesia.
A difficult intubation occurs in approx. 1.2 - 3.8 percent of all anaesthesias .
The standard procedure of intubation in Denmark is to use the curved Macintosh blade. This method, however, has some limits, as it requires a direct view of the area of the vocal cords. For that reason we are looking for new methods of intubation that can give a better overview.
The Truview PCD™ laryngoscope is a commercially available laryngoscope with an integrated optical lens that can be connected to a camera head, and gives a better view of trachea during intubation under a general anaestetic. Furthermore it is possible to connect 8-10 liters of oxygen per minute to the Truview PCD™ laryngoscope, which will prevent fog on the viewtube and slow down the rate of desaturation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients older than 18 years of age who are to undergo a surgery at the ENT department, Aalborg Hospital.
- •Patients who understand and accept the trial information.
- •SARI score 2-5.
排除标准
- •SARI score 0-1 and >
- •A need for acute initiation. (By acute initiation the endotracheal tube will be placed in trachea during the first laryngoscopy without prior spraying with local anesthesia).
- •If unexpected difficulties during the initiating anesthesia arise, the trial will be interrupted, and the patient will be treated according to the department's guidelines for the situation
结局指标
主要结局
Cormack Lehane (CL) grade
时间窗: The seconds during intubation where the anaesthesiologist view the vocal cords to determine the CL grade..
At the first laryngoscopy the patient is sprayed between plica vocalis with Lidocaine 4%, then the patient is ventilated by a mask. During the next laryngoscopy the intubation is performed (the endotracheal tube is placed in trachea). The patients are randomized by lottery as to which laryngoscope to be used first. After anesthesia induction, preceded by 3 minutes of preoxygenering, the first laryngoscope is used when spraying the patient with Lidocaine. Subsequently the patient is ventilated for 2 minutes, and then the intubation is performed by using the other laryngoscope.
次要结局
未报告次要终点
研究者
Per Henrik Lambert
Senior doctor
Aalborg University Hospital