跳至主要内容
临床试验/NCT03987009
NCT03987009终止不适用

Do the Head-elevated Position and the Use of a Videolaryngoscope Facilitate Orotracheal Intubation in a Patient Population Without Predictable Difficulty of Intubation

Hopital Foch10 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2019年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
Hopital Foch
入组人数
121
试验地点
10
主要终点
Proportion of oro-tracheal intubations for which it is necessary to use the assistance of a third party required by the operator

研究概览

简要总结

The main hypothesis of this study is that there is a synergy between the use of the HELP position and the use of a McGrath® Mac videolaryngoscope to facilitate tracheal intubation during anesthesia.

The HELP position is the patient positioning on the AirPal RAMP, the two cushions inflated, bringing the external auditory canal to the same level as the sus-sternal notch.

详细描述

Airway management remains an important determinant of morbidity and mortality in anesthesia, despite progress in recognizing factors of difficult mask ventilation and intubation. Many recommendations have been published regarding the practice of intubation in anesthesia. Our study focuses on two topics which remain under discussion: the position of the patient's head and the use of a videolaryngoscope.

As to patient's head position, most anesthesiologists place the patient in the sniffing position (supine torso with neck flexed forward, and head extended), a position denominated "sniffing"by analogy to that adopted to smell a perfume. However, Adnet et al. questioned this position based on magnetic resonance imaging of eight healthy young volunteers positioned either with their heads in a neutral position or in extension, or with their heads and necks on a pillow. They showed that the sniffing position does not allow the alignment of the three important axes (mouth, pharynx and larynx) in awake patients with normal airway anatomy [1]. The "Head Elevated Laryngoscopic position" (HELP), with a raise of the head and neck so that "An imaginary horizontal line should connect the patient's sternal notch with the external auditory meatus" [2] facilitates the alignment of the pharyngeal, laryngeal, and oral axes of the airway during difficult laryngoscopy [3].

As to videolaryngoscopy, there is no doubt that it is a major advance in airway management. A recent Cochrane Systematic Review concluded that videolaryngoscopy increased easy laryngeal views and reduced difficult views and intubation difficulty [4]. However, its place is still debated: first line or rescue in case of suspected difficult airway. Its systematic use means discarding the standard Macintosh laryngoscope [5] which is not supported by clinical studies, in particular those of Wallace et al. [6] and of Thion et al. [7].

In the present randomized study we will study a combination of two factors in tracheal intubation on patients without suspected airways abnormalities: position (sniffing or HELP) and a McGrath laryngoscope (with or without video). This leads to four groups, A: sniffing position plus McGrath Mac videolaryngoscope with its screen deactivated so as to mimic a plain laryngoscope (R-V-), B: HELP plus McGrath Mac videolaryngoscope with a deactivated video screen (R+V-), C: sniffing position plus a McGrath Mac videolaryngoscope with an activated video screen (R-V+), D: HELP plus a McGrath Mac videolaryngoscope with it video screen activated (R+V+). This protocol allows using the same type of laryngoscope in all cases.

研究设计

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

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 - 89 years old
  • Scheduled for elective surgical procedures
  • Requiring oro-tracheal intubation for general anesthesia
  • Having a telephone and agreeing to communicate their phone number in case of ambulatory surgery
  • Having signed an informed consent form
  • Benefiting from a social insurance

排除标准

  • Pregnant or breast-feeding women
  • Patients with an anticipated difficult mask ventilation or an anticipated difficult intubation (Arné's score ≥ 11)
  • Patients scheduled for a surgical procedure involving the mouth or the upper airway
  • Patients requiring a rapid induction sequence, the use of a double-lumen tube
  • Patients having a contra-indication to one of the drug administered by the protocol

结局指标

主要结局

Proportion of oro-tracheal intubations for which it is necessary to use the assistance of a third party required by the operator

时间窗: 30 minutes

Intubation is video and audio recorded. The number of people nedeed is determined from the audio/video recording a posteriori by two independent evaluators

次要结局

  • Evolution of Heart beat(30 minutes)
  • Time to perform the intubation(30 minutes)
  • First intubation succes rate(30 minutes)
  • Number of tracheal intubation failure(30 minutes)
  • Evolution of Blood pressure(30 minutes)
  • Assessment of the Quality of visualization of the glottis(30 minutes)
  • Assessment of the Percentage of the opening of the glottic orifice(30 minutes)
  • Assessment of quality of intubation with use of alternative techniques(30 minutes)
  • Occurrence of esophageal intubation(30 minutes)
  • Incidence of arterial oxygen desaturation (SpO2 < 92%)(30 minutes)
  • Cooperation of the various members of the anesthesia team(30 minutes)
  • Evaluation of severity of intubation complications(24 hours)
  • Perception of difficulty in intubation(30 minutes)
  • Evaluation of frequency of intubation complications(24 hours)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (10)

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