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临床试验/NCT03376828
NCT03376828已完成不适用

The Effect of Video and Traditional Laryngoscopy on Hemodynamic Response in Hypertensive and Normotensive Patients

Aydin Adnan Menderes University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年5月25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
发起方
入组人数
200
试验地点
2
主要终点
Hemodynamic response

研究概览

简要总结

During endotracheal intubation, it is known that la laryngoscopy has significant effects, such as tachycardia and blood pressure increase, which may be harmful, especially in those with cardiovascular disease. Different studies comparing laryngeal stimulation and there resulting hemodynamic response made with various intubation devices are available in the literature. The investigators planned to work with the hypothesis that endotracheal intubation with videolaryngoscopy would have less hemodynamic response traditional (Macintosh) laryngoscopy and the use of videolaryngoscopy would result in wider vision with less laryngeal stimulation.

详细描述

In this study, in a study on endotracheal intubation under general anesthesia, a routine preparation of endotracheal intubation using video laryngoscopy or Macintosh laryngoscopy in adult hypertensive and normotensive patients between 18-75 years old, form will be written and recorded.

Patient age, weight, height, sex, operation, co-morbid conditions and vital findings, measurements used in airway evaluation, initial trial success, laryngoscope using number of procedures, intubation tube number will be recorded.

Statistical analysis was performed using statistical program to compare the hemodynamic response of hypertensive and normotensive patients using videolaryngoscope or Macintosh laryngoscope

研究设计

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

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

入选标准

  • Age: 18-75 years.
  • Underwent surgery under general anesthesia.

排除标准

  • ASA (American Society of Anesthesiologists) IV, V patients
  • Preoperative systolic blood pressure 180 mmHg, diastolic blood pressure a pressure above 110 mmHg.
  • Ejection fraction is less than 40%.
  • Difficult intubation history
  • Mallampati 3,4

研究组 & 干预措施

Hypertensive T group

Active Comparator

Hypertensive T group: Patients participating in the study were randomly assigned hypertensive (preoperative systolic blood pressure <180 mmHg and diastolic blood pressure <100 mmHg) Macintosh laryngoscopy using intubated

干预措施: Macintosh laryngoscopy (Device)

Hypertensive VL group

Active Comparator

Hypertensive VL group: Patients participating in the study were randomly assigned hypertensive (preoperative systolic blood pressure <180 mmHg and diastolic blood pressure <100 mmHg) C-Mac Videolaryngoscope using intubated

干预措施: C-Mac Videolaryngoscope (Device)

Non-hypertensive T group

Sham Comparator

Non-hypertensive T group: (Preoperative systolic blood pressure < 140 mmHg and diastolic blood pressure < 100 mmHg) Macintosh laryngoscopy using intubated

干预措施: Macintosh laryngoscopy (Device)

Non-hypertensive VL group

Sham Comparator

Non-hypertensive VL group: Preoperative systolic blood pressure < 140 mmHg and diastolic blood pressure < 100 mmHg C-Mac Videolaryngoscope using intubated

干预措施: C-Mac Videolaryngoscope (Device)

结局指标

主要结局

Hemodynamic response

时间窗: 0-10 minute

Change from baseline noninvasive blood pressure and heart rate

次要结局

  • intubation time(0-120 seconds)
  • Glottic view grade(During intubation)

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

SİNAN YILMAZ

Principal Investigator

Aydin Adnan Menderes University

研究点 (2)

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