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Pilot Study on the Use of Video Laryngoscopy in Pre-hospital Settings (VIDEOPREHOSP)

2026年6月3日 更新者:Centre Hospitalier de Valenciennes

Pilot Study on the Use of Video Laryngoscopy in Pre-hospital Settings: Evaluation of the Success Rate of Intubation on the First Attempt, Highlighting Criteria Specific to the Patient, the Practitioner and the Environment That May Influence This Rate.

Management of the upper airways is an essential skill in pre-hospital medicine in order to protect the respiratory tract and optimise ventilation and oxygenation. Orotracheal intubation remains the gold standard method in this context. In France, approximately 8% of primary SMUR interventions require intubation, representing 40,000 to 50,000 procedures per year, 30 to 40% of which are performed on patients in cardiorespiratory arrest.

Despite an overall success rate of nearly 99%, 8 to 15% of intubations are considered difficult and the success rate on the first attempt is only 77.8%. Difficult intubations expose patients to significant complications, including desaturation (nearly 50% of cases), haemodynamic disorders and, more rarely, cardiopulmonary arrest (3% of cases). Pre-hospital conditions (environment, access to the patient, trauma, secretions, etc.) increase these risks. As a result, recent recommendations now consider any emergency intubation outside the operating theatre to be potentially difficult.

The introduction of video laryngoscopy represents a major technological advance. Its superiority has been demonstrated in hospital settings, particularly for difficult intubations, and it is now recommended as the first-line treatment in this context. However, unlike in the United States, where several studies suggest that it is safer and more effective than direct laryngoscopy, there are no specific recommendations or French studies concerning its use in pre-hospital medicine.

Given these factors and the lack of national data, it seems appropriate to conduct an exploratory French study to assess the place, effectiveness, benefits and constraints of video laryngoscopy in a pre-hospital setting. Investigator hypothesises that the success rate for the first attempt at intubation using video laryngoscopy will be 74%.

研究概览

详细说明

This is a single-arm exploratory interventional study conducted at the Valenciennes Hospital Centre.

Firstly, practical training in video laryngoscopy has already been provided by Dr GOZE to doctors participating in the SMUR (mobile emergency and resuscitation service) at the Valenciennes Hospital Centre. In Appendix 1, the training certificates of the doctors who submitted their CVs during the initial application process have been included in the protocol. Any investigator wishing to participate in the study and include patients will be required to undergo training and submit an application to the CPP. A presentation of the study will also be given to practitioners.

Before the study is conducted, an explanatory sheet will be given to each practitioner, along with a questionnaire concerning their practice and experience of video laryngoscopy intubation.

From the start of the study, once authorisation has been granted by the CPP, all out-of-hospital intubations will be performed as a first-line treatment using a video laryngoscope, as required by the research protocol. If intubation fails on the first attempt, the practitioner will be free to choose whether to continue with the intubation technique of their choice.

A results sheet will be completed by the operator after each procedure. The results recorded will be: the outcome of the first intubation attempt (success or failure), and the criteria corresponding to the secondary criteria described above.

研究类型

介入性

注册 (估计的)

143

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。

学习联系方式

学习地点

      • Valenciennes、法国、59300
        • 招聘中
        • Centre Hospitalier de Valenciennes
        • 接触:
          • Alexandre ANDRIES, MD

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

Patient Inclusion Criteria:

  • Age > 18 years
  • Patients treated pre-hospital by a team from the Emergency Medical and Resuscitation Service (SMUR) at Valenciennes Hospital 2025-A02374-45_SUMMARY_v1.1 dated 04/12/2025 _VIDEOPREHOSP Page 3 of 4
  • Patients whose condition requires pre-hospital orotracheal intubation
  • Patient or relative who has given consent for inclusion
  • Patient affiliated with a social security scheme

Pratician Inclusion Criteria :

  • Practitioner at Valenciennes Hospital
  • Practitioner who is part of the EMS team

Exclusion Criteria:

  • Progressive pregnancy
  • Theoretical indication for orotracheal intubation but patient refuses invasive care, considered in this situation to be futile medical care
  • Insurmountable anatomical obstacle, in which case an emergency cricothyroidotomy or tracheotomy should be considered as the first line of treatment
  • Patients under guardianship or curatorship
  • Patients deprived of their liberty by court order

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:不适用
  • 介入模型:单组作业
  • 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:Experimental arm
All patients in a pre-hospital emergency situation for whom videolaryngoscopy was performed on the first attempt.

This is a single-centre study conducted at Valenciennes Hospital. Eligible patients will be those requiring intubation in a life-threatening emergency as part of standard care.

During each SMUR intervention, patients will be assessed to determine their eligibility for the study, according to the inclusion and exclusion criteria previously defined in the protocol. This verification will be carried out by the practitioner in charge of pre-hospital care, before the intubation procedure is performed. The clinical data required for this assessment will be collected prospectively.

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 main objective of this exploratory study is to estimate the success rate of the first attempt at pre-hospital video laryngoscopy intubation.
大体时间:immediately after orotracheal intubation
The primary endpoint is the success rate of intubation on the first attempt. The endpoint analysed will be a binary measure (success: 1 / failure: 0) collected during the procedure.
immediately after orotracheal intubation

次要结果测量

结果测量
措施说明
大体时间
Secondary objective N°1 : To study the correlation between patient-related constraints in the use of video laryngoscopy and the success/failure of the first intubation attempt.
大体时间:immediately after orotracheal intubation

The aim is therefore to study the main variable (success or failure of intubation on the first attempt) in relation to different variables that have different units of measurement.

Constraints encountered during intubation related to the patient:

  • Mouth opening: < 2 cm, between 2 and 3.5 cm, > 3.5 cm
  • Thyro-mental distance: < 5 cm, between 5 and 6.5 cm, > 6.5 cm
  • Cormack score: I/II, III/IV
  • Obesity (BMI > 30): Yes/No
  • Presence of secretions in the upper airways: Yes/No
  • Presence of cervical-facial trauma: Yes/No
immediately after orotracheal intubation
Secondary outcome N°2 : To investigate the correlation between the constraints of using video laryngoscopy in an out-of-hospital setting and the success/failure of the first intubation attempt
大体时间:immediately after orotracheal intubation

The aim is therefore to study the main variable (success or failure of intubation on the first attempt) in relation to different variables that have different units of measurement.

Constraints encountered during intubation, related to the practitioner:

  • Years of experience as an emergency physician
  • Number of successful intubations using video laryngoscopy: < 15, between 15 and 50, > 50
immediately after orotracheal intubation
Secondary objective N°3 : To investigate the correlation between the constraints of using video laryngoscopy in an out-of-hospital setting and the success/failure of the first intubation attempt
大体时间:Immediately after video laryngoscopy

The aim is therefore to study the main variable (success or failure of intubation on the first attempt) in relation to different variables that have different units of measurement.

Constraints encountered during intubation in an out-of-hospital setting:

  • Patient position: On the ground or on a stretcher
  • Practitioner position: Lying down, kneeling, or standing
  • Bright light interfering with visibility on the video laryngoscope: Yes or No
Immediately after video laryngoscopy

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。

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)

2026年1月2日

初级完成 (估计的)

2026年12月2日

研究完成 (估计的)

2026年12月2日

研究注册日期

首次提交

2026年1月6日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月5日

研究记录更新

最后更新发布 (实际的)

2026年6月5日

上次提交的符合 QC 标准的更新

2026年6月3日

最后验证

2026年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2025-02-03

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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