跳至主要内容
临床试验/NCT05494463
NCT05494463已完成不适用

Comparison of the Miller Laryngoscope and the Macintosh Laryngoscope During Endotracheal Intubation in Adult Patients

Medical University of Lodz1 个研究点 分布在 1 个国家目标入组 1,130 人开始时间: 2022年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,130
试验地点
1
主要终点
Number of Grade of view of entrance to larynx

研究概览

简要总结

The study compares laryngeal view obtained with standard Macintosh blade laryngoscope and Miller blade laryngoscope in adult patients. After introduction to general anesthesia anesthesiologist will perform laryngoscopy with one chosen blade and after evaluation of visualisation of entrance to larynx will change blade to second one and repeat evaluation.

详细描述

Tracheal intubation is the gold standard of the airway in the operating theater in patients undergoing general anesthesia for surgery, in intensive care and emergency medicine, in patients with severe respiratory failure, which is life-threatening. The laryngoscope is a device used to visualize the entrance to the airway and the subsequent insertion of the tracheal tube into the trachea and main bronchus. Macintosh and Miller laryngoscopes have been used in clinical practice for several decades. The Macintosh laryngoscope is most commonly used for the intubation of adult patients, and the Miller laryngoscope for the intubation of newborns, including premature babies and pediatric patients. Currently, when we are dealing with the sars covid-19 virus epidemic and a large number of patients with respiratory failure requiring endotracheal intubation and replacement ventilation, searching for a device that facilitates endotracheal intubation, especially by people with little experience in using it, in the absence of anesthesiologists, seems to be justified. The aim of the study will be to assess the possibility of using the Miller's laryngoscope for intubation of adult patients and to compare it with the most frequently used Macintosh laryngoscope in this group of patients. The study will include patients scheduled for elective surgery under general endotracheal anesthesia. After a typical induction of anesthesia with the use of short-term intravenous anesthetics, opioids and muscle relaxants, appropriate for the planned surgery and a specific patient, after obtaining complete neuromuscular blockade, a Macintosh laryngoscope will be inserted to perform direct laryngoscopy and assess the exit to the respiratory tract with the help of the Cormack scale. Then the laryngoscope will be removed, the patient will receive active oxygen therapy to increase blood oxygenation to the value of 99-100%, and then an additional dose of intravenous anesthetic will be administered and a second direct laryngoscopy will be performed with the Miller's laryngoscope with a subsequent assessment of airway entry using the scale Cormack. The patient will then be intubated and connected to an anesthesia machine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients scheduled for elective procedures under general anesthesia with endotracheal intubation

排除标准

  • patients with expected difficutl intubation requiring advanced intubation techniques
  • with injuries of the cervical spine, or for surgery in the cervical spine
  • patients with increased intracranial and intraocular pressure, with vascular changes in the CNS and other parts of the body
  • patients with ASA III and above
  • patients who do not consent to participate in the study

研究组 & 干预措施

Macintosh blade

No Intervention

laryngoscopy with Macintosh blade

Miller blade

Active Comparator

laryngoscopy with Miller blade in the same patient

干预措施: Miller blade (Device)

结局指标

主要结局

Number of Grade of view of entrance to larynx

时间窗: immediate

Laryngoscopy with Macintosh blade and then with Miller blade in the same patient, grade of view estimated in Cormack-lehane scale and POGO - percentage of glottis opening

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验