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Does Glidescope Video Laryngoscope is Related to Less Hemodynamic Response?

2017年6月12日 更新者:Gata Haydarpasa Research Hospital

Comparison of Hemodynamic Responses to Endotracheal Intubation With Glidescope Video Laryngoscope and Macintosh Direct Laryngoscope in Patients Undergoing Coronary Artery Bypass Surgery

Laryngoscopy and endotracheal intubation causes significant hemodynamic response and thus presents an increased risk for patients undergoing cardiac bypass surgery. Prevention or reduction of this increment is important for hemodynamic control. In this randomized single blind study, the aim of this study is to compare the hemodynamic responses of two different laryngoscopy techniques with Glidescope and Macintosh laryngoscope in coronary cardiac bypass surgery patients.

研究概览

详细说明

Laryngoscopy and endotracheal intubation causes significant hemodynamic response and thus presents an increased risk for patients undergoing cardiac bypass surgery. Prevention or reduction of this increment is important for hemodynamic control. In this randomized single blind study, the aim of this study is to compare the hemodynamic responses of two different laryngoscopy techniques with Glidescope and Macintosh laryngoscope in coronary cardiac bypass surgery patients. After induction with our institutional protocol for cardiac bypass surgery, hemodynamic data including heart rate, systolic and diastolic arterial pressure data will be recorded. Time for intubation, age, sex, ASA status data will also be recorded.

研究类型

介入性

注册 (实际的)

70

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Asia
      • İ̇stanbul、Asia、火鸡、34668
        • GATA Haydarpasa Training Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 85年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical Status 2-3
  • Patients undergoing elective cardiac bypass surgery

Exclusion Criteria:

  • Difficult intubation history
  • Need for Rapid sequence intubation or alternative intubation method
  • Emergency procedures
  • Patients that have predictive factors for difficult intubation
  • Patients with permanent pacemaker

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Glidescope intubation
This standard GlideScope (GS) technique involves a midline laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.
This standard GlideScope (GS) technique involves a midline laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.
其他:Macintosh Laryngoscope
This standard technique involves laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.
This technique involves a laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in systolic blood pressure
大体时间:5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
invasive blood pressure (mmHg) monitoring
5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
Change in heart rate
大体时间:5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
Heart rate (beats per minute) will be measured before induction, and throughout and after laryngoscopy
5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
Change in diastolic blood pressure
大体时间:5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
invasive blood pressure (mmHg) monitoring
5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
Change in mean arterial pressure
大体时间:5 minutes;At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
invasive blood pressure (mmHg) monitoring
5 minutes;At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes

次要结果测量

结果测量
措施说明
大体时间
Procedure time
大体时间:10 minutes
Total laryngoscopy and intubation time (minutes)
10 minutes
Cormack lehane laryngoscopic view will be recorded
大体时间:10 minutes
laryngoscopic view data will be recorded according to Cormack Lehane scale (A Scale with 1-4)
10 minutes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Sezai Ozkan, Prof.、Gata Haydarpasa Research Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年1月1日

初级完成 (实际的)

2017年5月18日

研究完成 (实际的)

2017年6月1日

研究注册日期

首次提交

2016年2月27日

首先提交符合 QC 标准的

2016年3月9日

首次发布 (估计)

2016年3月15日

研究记录更新

最后更新发布 (实际的)

2017年6月14日

上次提交的符合 QC 标准的更新

2017年6月12日

最后验证

2016年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Glidescope的临床试验

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