protocolSection identificationModule nctId: NCT06307392, orgStudyIdInfo id: RC22_0393, briefTitle: Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation (BETA Trial), acronym: BETA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2027-03-26, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: Emergency intubation is routinely performed in the prehospital setting. Airway management in the prehospital setting has substantial challenges, such as hostile environment or lack of technical support in case of first attempt intubation failure, and inherent risk of complications, such as hypoxemia, aspiration or oesophageal intubation. This risk is higher when several attempts are needed to succeed endotracheal intubation. Thus, a successful first attempt intubation is highly desirable to avoid adverse intubation-related events. Noteworthy, prehospital emergency intubation is associated with a lower rate of first attempt intubation success when compared to emergency intubation in the emergency department (ED). Research is needed to overcome the specific challenges of airway management in the prehospital setting, and to improve the safety and efficiency of prehospital emergency intubation. Literature reports that the use of assistive devices such as bougie may increase the rate of first-attempt intubation success in the ED. To date, no randomized trial has ever studied this device in the prehospital setting. Thus, the aim of the BETA trial is to compare first attempt intubation success facilitated by the bougie versus the endotracheal tube alone in the prehospital setting., conditionsModule conditions: Acute Respiratory Failure Requiring Intubation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 710, type: ESTIMATED, armsInterventionsModule interventions name: First intubation attempt with endotracheal tube plus bougie, interventions name: First intubation attempt with endotracheal tube alone, outcomesModule primaryOutcomes measure: Number of first pass success during prehospital emergency intubation, secondaryOutcomes measure: Occurrence of hypoxia, secondaryOutcomes measure: Occurrence of bradycardia, secondaryOutcomes measure: Occurrence of cardiac arrest, secondaryOutcomes measure: Occurrence of death, secondaryOutcomes measure: Occurrence of pulmonary aspirations, secondaryOutcomes measure: Occurrence of severe cardiovascular collapse, secondaryOutcomes measure: Time between blade introduction to the confirmation of a correct tube placement, secondaryOutcomes measure: Change in SpO2 (pulsed oxygen saturation) from the time of induction to lowest SpO2 up to 2 minutes after confirmation of correct tube placement, secondaryOutcomes measure: Occurrence of change in SpO2 of more than 3% from the time of induction to 2 minutes after confirmation of correct tube placement, secondaryOutcomes measure: Cormack-Lehane grade of glottic view at first intubation attempt, secondaryOutcomes measure: Number of laryngoscopies attempts to achieve correct endotracheal tube placement, secondaryOutcomes measure: Number of patients for whom the placement of an endotracheal tube was not possible in the pre-hospital setting, secondaryOutcomes measure: Difficulty perceived by the operator on first intubation attempt, secondaryOutcomes measure: Occurrence of injuries, secondaryOutcomes measure: Occurrence of complications, secondaryOutcomes measure: Change of SpO2/FiO2 ratio (pulsed oxygen saturation / fraction of inspired oxygen) between the time of confirmation of correct tube placement and the minimum ratio, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nantes University Hospital, status: RECRUITING, city: Nantes, state: Loire Atlantique, zip: 44093, country: France, contacts name: Quentin Le Bastard, MD, role: CONTACT, phone: 0240087839, email: quentin.lebastard@chu-nantes.fr, contacts name: Quentin Le Bastard, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.21725, lon: -1.55336, hasResults: False