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

Официальное название

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.

Обзор

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%.

Подробное описание

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.

Вмешательства

• Устройство Videolaryngoscopy in first attempt in prehospital with AirTraq
  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 performe

Первичные конечные точки

• The main objective of this exploratory study is to estimate the success rate of the first attempt at pre-hospital video laryngoscopy intubation. [Срок оценки: immediately after orotracheal intubation]

Вторичные конечные точки (3)

• 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. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Immediately after video laryngoscopy]

Критерии участия

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Centre Hospitalier de Valenciennes — Valenciennes

Идентификаторы

NCT: NCT07630467 · 2025-02-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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