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临床试验/NCT02564640
NCT02564640已完成不适用

Comparison of Hemodynamic Changes After Endotracheal Intubation by Using the Videolaryngoscope and the Macintosh Direct Laryngoscope in Elderly Hypertensive Patients

Antalya Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Blood pressure changes during tracheal intubation ( mmHg ) ,

研究概览

简要总结

Tracheal intubation techniques that avoid or minimize pharyngolaryngeal stimulation might attenuate the hemodynamic stress response. Tracheal intubation using video laryngoscope needs comparatively less airway manipulation so, the investigators expect less hemodynamic response while using videolaryngoscope.

详细描述

The hemodynamic stress response to tracheal intubation can precipitate adverse cardiovascular events in patients with cardiovascular disease. Which is shown to greatly increase the risk of myocardial infarction or stroke, especially in elderly patients with hypertension. Direct laryngoscopy and laryngoscopic stimulation of pharyngolaryngeal structures may be an important factor in the hemodynamic stress response associated with tracheal intubation.

Patients were randomly allocated to two groups using a permuted block randomization method: 1) patients intubated by using the videolaryngoscopy 2) patients intubated by using the Macintosh laryngoscope . SAP, MAP, and heart rate were measured and recorded in the operating room: At baseline, before intubation, immediately after intubation and 1,2,3,4 and 5 minutes after tracheal intubation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • American Society of Anesthesiologists Physical Status II-III,
  • aged over 65 years,
  • controlled hypertensive patients,
  • scheduled for elective coronary artery bypass grafting.

排除标准

  • American Society of Anesthesiologists Physical Status IV,
  • ejection fraction < 40%,
  • any anatomical abnormality in head, neck or face,
  • Mallampati score of IV,
  • history of difficult intubation or laryngoscopy

结局指标

主要结局

Blood pressure changes during tracheal intubation ( mmHg ) ,

时间窗: At baseline, 1 minute before intubation, and 1,2,3,4 and 5 minutes after tracheal intubation

次要结局

  • ST segment elevation in electrocardiogram indicating myocardial ischaemia during tracheal intubation(At baseline, 1 and 5 minutes after tracheal intubation.)
  • Arrhythmic changes in electrocardiogram during tracheal intubation(At baseline, 1 and 5 minutes after tracheal intubation.)
  • Heart rate changes during tracheal intubation (beats per minute)(At baseline, 1 minute before intubation, and 1,2,3,4 and 5 minutes after tracheal intubation)

研究者

发起方
Antalya Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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