Centre Hospitalier de Valenciennes
Valenciennes, 59300, France
Location status: Recruiting
Location contact
Alexandre ANDRIES, MD
CONTACT
NCT Number: NCT07630467
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%.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Valenciennes, 59300, France
Location status: Recruiting
Alexandre ANDRIES, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patient Inclusion Criteria:
Pratician Inclusion Criteria :
Exclusion criteria
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.
Time frame: 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.
Time frame: 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:
Time frame: 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:
Time frame: 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:
Contact information is provided by the study sponsor or research team.
Centre Hospitalier de Valenciennes
Network
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.
Acronym: VIDEOPREHOSP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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