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临床试验/NCT02305667
NCT02305667已完成不适用

A Comparison of Three Videolaryngoscopes for Double-Lumen Tubes Intubation in Humans. A Randomized Controlled Study

Imam Abdulrahman Bin Faisal University2 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
133
试验地点
2
主要终点
Time to the duration of endobronchial intubation

研究概览

简要总结

Introduction: Compared with the Macintosh laryngoscopy (MAC), the videolaryngoscopes (VL) provide superior glottis views and longer times to double-lumen tube (DLT) intubation. We hypothesize that the use of the King Vision™ (KVL) and the Airtraq® VLs may reduce the time for DLT intubation compared with the Glidescope® (GVL) and MAC in patients undergoing thoracic procedures.

Methods: One hundred-forty patients who will be scheduled for elective thoracic procedures using the DLT for one-lung ventilation will be randomly assigned to one of four groups (n=35 per group) to intubate using the MAC, GVL, Airtraq®, or KVL. Time to DLT intubation, glottis view, ease of intubation, number of optimization maneuvers, and failure to intubation (>150 s.) will be recorded.

详细描述

Several regional surveys among thoracic anesthesiologists showed that the double-lumen endobronchial tubes (DLT) is still the first choice for lung separation.[1-3] The introduction of videolaryngoscopes (VL) enables the use of the DLTs instead of a bronchial blockers for lung separation in patients with difficult airway.[4-5]

There are numerous VLs, including, stylets, channeled and traditional VLs. The GlideScope®-assisted DLT insertion (Verathon Inc., Bothell, WA, USA), has been associated with variable intubation durations according to the experience of the intubating operators, despite superior vocal cord views.[6-7] The channeled VL, like as the Airtraq® (Prodol Limited, Viscaya, Spain) and the standard non-channeled blade of the King Vision™ (KVL™) (King Systems, Indianapolis, IN, USA), may offer additional benefits for DLT intubation in patients with limited mouth opening or restricted neck movement, [8-10] in whom the use of traditional VL like as the Glidescope® could be difficult. This is because of the larger outer diameter, the distal curvature and the increased rigidity of the DLT.[11]

Of note, the longer intubation durations with the use of different VL-assisted DLT insertion could be shortened with building up the operator's experience.

Comparing the effects of the three studied VLs on the time to DLT intubation in humans has not yet been studied.

We hypothesize that time to successful DLT intubation using the channeled VL, namely, the Airtraq® and KVL™, will be shorter than with the Macintosh (MAC) laryngoscope and GlideScope® VL when used by non-expert anesthesiologists. We will compare the effects of the MAC, GlideScope®, Airtraq® and KVL™ on the time to DLT intubation, laryngoscopic view, ease of intubation, number of intubation attempts, and number of optimization maneuvers in patients undergoing thoracic procedures using DLTs for one-lung ventilation (OLV).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists' physical status II/III
  • Elective thoracic procedures

排除标准

  • New York Heart Association (NYHA) functional classification class III to IV
  • forced expiratory volume in 1 s (FEV1) less than 50% of predicted values
  • forced vital capacity (FVC) less than 50% of predicted values
  • severe asthma
  • pregnancy
  • risk of regurgitation
  • risk of pulmonary aspiration
  • history of gastro-esophageal reflux
  • body mass index more than 40 kg m-2
  • anticipated difficult intubation
  • preoperative postoperative ventilatory support
  • planned postoperative ventilatory support

结局指标

主要结局

Time to the duration of endobronchial intubation

时间窗: 3 minutes after laryngoscopy

defined as the time from when the laryngoscope entered between the patient's lips until successful DLT placement (regardless of the number of attempts).\[

次要结局

  • best obtained glottis view during laryngoscopy(30 sec after laryngosocopy)
  • ease of endobronchial intubation(30 sec after laryngosocopy)
  • number of optimization maneuvers(150 sec after laryngosocopy)
  • number of the 'backwards upwards rightwards pressure' (BURP) maneuver(150 sec after laryngosocopy)
  • failure rate for double lumen tube intubation(150 sec after laryngosocopy)
  • sore throat(48 hours after surgery)
  • hoarseness(48 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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