Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

3 juni 2026 bijgewerkt door: 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%.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

143

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

      • Valenciennes, Frankrijk, 59300
        • Werving
        • Centre Hospitalier de Valenciennes
        • Contact:
          • Alexandre ANDRIES, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The main objective of this exploratory study is to estimate the success rate of the first attempt at pre-hospital video laryngoscopy intubation.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 januari 2026

Primaire voltooiing (Geschat)

2 december 2026

Studie voltooiing (Geschat)

2 december 2026

Studieregistratiedata

Eerst ingediend

6 januari 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

3 juni 2026

Laatst geverifieerd

1 januari 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren