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Does a Customized Intubation Facility Reduce Incidence of Difficulty (Person-OTI)

2026年6月9日 更新者:Hopital Foch

Does a Customized Intubation Facility Reduce Incidence of Difficulty: Randomized Multicenter Trial?

The idea of this study is to demonstrate that the position of the head at a comfort height spontaneously expressed by the patient, between Jackson's amended position or Ramp position, significantly improves the quality of the intubation gesture. This patient position can be easily achieved by placing a compressed air mattress under the patient's trunk - AirPal RAMP ™ mattress.

Thus the investigators can assume that the appropriate positioning and use of a video laryngoscope (McGrathR Mac) places the patient in the best anatomical configuration to breathe and, indirectly to facilitate control of the airways, especially for those with a risk of difficult airway management.

研究概览

详细说明

  1. Position for orotracheal intubation The period preceding the administration of anesthetic agents is essential to ensure a satisfactory oxygen supply (pre-oxygenation). Then, once loss of consciousness is achieved, an interface (oral intubation probe) is put in place to allow mechanical ventilation during the procedure. This phase can be marked by a more or less expected difficulty depending on the risk factors presented by the patient. Thus an Arne score> 11 is predictive of a potential difficulty which may lead to an alternative technique being proposed. Simple techniques also exist in the patient setup to reduce the incidence of difficulties. Among them, the placement of a cushion under the head with a slight extension of the head of 20 ° (Jackson's amended position) is recommended because it allows to obtain the alignment of the posterior pharyngeal and glottic spaces. This patient position can be easily achieved by placing a compressed air mattress under the patient's trunk - AirPal RAMP ™ mattress.

    This optimization of the position according to the patient, between Jackson's amended position or Ramp position, opens up the prospect of defining an optimal position personalized to each patient. Thus, it can be assumed that the appropriate positioning places the patient in the best anatomical configuration for breathing and, indirectly, to facilitate control of the airways.

  2. Video laryngoscope The use of a video laryngoscope (McGrathR Mac) is becoming widespread in anesthesia, especially for the management of patients at risk of difficult airway management. This device by the video support at the end of the blade provides a better visualization of the glottic orifice.
  3. The hypothesis of this research The idea of this study is to demonstrate that the position of the head at a height of comfort spontaneously expressed by the patient significantly improves the quality of the intubation procedure.

研究类型

介入性

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

      • Suresnes、法国、92150
        • Morgan LE GUEN, PhD

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Men or women over 18 and under 80;
  • Must undergo general anesthesia with oral intubation using a standard intubation probe;
  • Can be contacted directly by telephone if they are patients treated in outpatient surgery;
  • Having signed a consent form;
  • Being affiliated to a Health Insurance scheme.

Exclusion Criteria:

  • pregnant or breastfeeding patients;
  • patients with a predicted difficulty in mask ventilation or intubation according to the assessment of the doctor who performs the clinical examination prior to inclusion (Arne score ≥ 11) or the one who takes care of the patient in the block operative;
  • patients for whom the surgery requires the placement of a double-lumen tube;
  • patients requiring rapid sequence induction;
  • patients for whom induction cannot be carried out by the sufentanil, propofol, atracurium or rocuronium sequence.

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:其他
  • 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
实验性的:Custom
patient with installation on an infused airbag until a comfortable position is reached
patient with personalized installation until a comfortable position is reached
无干预:Control
Jackson's amended position with placement of a 6 cm high cushion under the patient's head

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
the impact of a custom installation versus a conventional Jackson amended installation with a 6-centimeter cushion under the patient's head to facilitate orotracheal intubation
大体时间:1 day
the proportion of orotracheal intubations for which third party assistance is required
1 day

次要结果测量

结果测量
措施说明
大体时间
Assessment of the effect of patient positioning on the quality of exposure during intubation
大体时间:1 day
  • the duration of the intubation;
  • the quality of visualization of the glottis;
  • failure of intubation defined by reexposure, by esophageal intubation;
  • the calculation of the Intubation Difficulty Scale (or IDS)
1 day
Determination of the most frequent complementary resettlement actions
大体时间:1 day
  • the ideal position chosen by the patient (and measured) before the start of the procedure;
  • the patient's position (measured) when the intubation is successful. The intubation time will be correlated with these measurements and the angles that will be deduced from them;
  • additional techniques used at the time of intubation.
1 day
Assessment of the quality of manual ventilation before intubation (peroxygenation)
大体时间:1 day
  • the use of a Guédel cannula;
  • the number of hands required for ventilation;
  • the percentage of leakage;
  • minimal SpO2;
  • maximum ETCO2.
1 day
Assessment of the frequency and severity of complications of intubation
大体时间:2 days
The complications of intubation was defined by the pharyngeal pain the day after surgery, dysphonia, an irritative cough reported by the patient and atelectasis.
2 days
Assessment of patient comfort and the doctor's opinion on the technique
大体时间:1 day
The doctor's opinion on the technique was defined by the regard to pre-oxygenation, peroxygenation, and intubation.
1 day
Safety assessment of the technique
大体时间:1 day
Safety was evaluated by the occurrence of a fall of the head, occurrence of a fall of the patient, accidental extubation, the incidence of arterial oxygen desaturation, the lowest arterial oxygen saturation and the perception of difficulty in intubation.
1 day

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。

赞助

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 (实际的)

2022年1月5日

初级完成 (实际的)

2024年1月5日

研究完成 (实际的)

2024年1月12日

研究注册日期

首次提交

2021年8月6日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月15日

研究记录更新

最后更新发布 (实际的)

2026年6月15日

上次提交的符合 QC 标准的更新

2026年6月9日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2020_0030

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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