NCT07630467

Brief Summary

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%.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Jan 2026Dec 2026

Study Start

First participant enrolled

January 2, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2026

Last Updated

June 5, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

January 6, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

orotracheal intubationpre-hospitalfirst attemptvideolaryngoscopy

Outcome Measures

Primary Outcomes (1)

  • The main objective of this exploratory study is to estimate the success rate of the first attempt at pre-hospital video laryngoscopy 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

Secondary Outcomes (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.

    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

    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

    Immediately after video laryngoscopy

Study Arms (1)

Experimental arm

EXPERIMENTAL

All patients in a pre-hospital emergency situation for whom videolaryngoscopy was performed on the first attempt.

Device: Videolaryngoscopy in first attempt in prehospital with AirTraq

Interventions

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.

Experimental arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 affiliated with a social security scheme
  • Practitioner at Valenciennes Hospital
  • Practitioner who is part of the EMS team

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Valenciennes

Valenciennes, 59300, France

RECRUITING

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Alexandre ANDRIES, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This study will be conducted in a single centre, i.e. it will take place exclusively at one hospital, namely the Valenciennes Hospital Centre (CHV). More specifically, the interventions will take place at sites where the CHV's Mobile Emergency and Resuscitation Service (SMUR) team operates, i.e. the locations where this specialised team is deployed or dispatched. The main participants in this study will be hospital practitioners from the Valenciennes Hospital Centre who are actively involved in SMUR missions. These practitioners, who are experts in pre-hospital emergency care, will play a central role in data collection and implementation of the study protocol.
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2026

First Posted

June 5, 2026

Study Start

January 2, 2026

Primary Completion (Estimated)

December 2, 2026

Study Completion (Estimated)

December 2, 2026

Last Updated

June 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations