跳至主要内容
临床试验/NCT03657927
NCT03657927已完成不适用

A Comparison of McGrath® MAC Versus C-MAC® Videolaryngoscopes in Morbidly Obese Patients Undergoing Bariatric Surgery: A Randomized, Controlled Clinical Trial

Inonu University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年9月8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
80
试验地点
2
主要终点
Time to intubation

研究概览

简要总结

Along with the technological advances in medicine, videolaryngoscope is the most commonly preferred technique for intubation of expected difficult airway management such as morbidly obese patients. In this prospective controlled clinical study, the purpose is to compare C-MAC videolaryngoscope and McGrath MAC videolaryngoscope in respect to duration of intubation, haemodynamic response, and complications related intubation of morbidly obese patients undergoing bariatric surgery.

详细描述

It is very important for anesthesiologists to evaluate and make the airway safe in order to start and continue surgical operations. Endotracheal intubation has many important reasons such as ensuring airway control safely during surgical procedure, increasing the depth of anesthesia, need interventions for surgical or anesthetic complications, reduction of dead space, reduction of respiratory effort and prevention of aspiration risk.

Mask ventilation and tracheal intubation in morbidly obese patients can be difficult with the anatomical changes caused by obesity. Reduced functional residual capacity in morbidly obese patients makes it difficult to maintain peripheral oxygen saturation at normal limits. Videolaryngoscope, developed in recent years and beginning to take place in the algorithms, facilitate difficult airway management and hence intubation.

The use of videolaryngoscope in patients with difficult intubation such as morbid obesity, has been frequently reported in the literature. McGrath videolaryngoscope has a high-resolution video camera, a length-adjustable angle blade, and a light source at the tip of the blade. At the same time, the C-MAC videolaryngoscope is another advanced videolaryngoscope with a better quality video and camera system and improves the performance of videolaryngoscope with some technological changes.

In this prospective controlled clinical study, the purpose is to compare C-MAC videolaryngoscope and McGrath MAC videolaryngoscope in respect to duration of intubation, haemodynamic response, and adverse events associated with intubation of morbidly obese patients undergoing bariatric surgery.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiology score III,
  • 18-65 years,

排除标准

  • American Society of Anesthesiology IV,
  • Under 18 years,
  • Over 65 years,
  • Under BMI<40
  • Obstetric patients,
  • Uncontrolled cerebrovascular disease,
  • Patients who refused written informed consent forms

研究组 & 干预措施

C-MAC Videolaryngoscope

Active Comparator

Morbidly obese patients intubated with C-MAC Videolaryngoscope

干预措施: C-MAC videolaryngoscope (Device)

C-MAC Videolaryngoscope

Active Comparator

Morbidly obese patients intubated with C-MAC Videolaryngoscope

干预措施: McGrath MAC videolaryngoscope (Device)

McGrath MAC Videolaryngoscope

Active Comparator

Morbidly obese patients intubated with McGrath MAC Videolaryngoscope

干预措施: C-MAC videolaryngoscope (Device)

McGrath MAC Videolaryngoscope

Active Comparator

Morbidly obese patients intubated with McGrath MAC Videolaryngoscope

干预措施: McGrath MAC videolaryngoscope (Device)

结局指标

主要结局

Time to intubation

时间窗: From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes

Time to intubation was defined as the time from when the anesthesiologist picked up the videolaryngoscope to when the anesthesiologist successfully placed the endotracheal tube through the vocal cords

次要结局

  • Heart Rate(From beginning of Anesthesia induction to 5th minutes of intubation)
  • Mean Arterial Pressure(From beginning of Anesthesia induction to 5th minutes of intubation)
  • Adverse Events(During the first 24 hour postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sedat AKBAS

Asst. Prof. Dr. Sedat Akbas

Inonu University

研究点 (2)

Loading locations...

相似试验

A Comparison of McGrath MAC Versus C-MAC... | 临床试验