nctId: NCT06307392 id: RC22_0393 briefTitle: Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation (BETA Trial) acronym: BETA overallStatus: RECRUITING date: 2024-03-26 date: 2027-03-26 date: 2027-03-31 date: 2024-03-12 date: 2024-04-05 name: Nantes University Hospital class: OTHER 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. conditions: Acute Respiratory Failure Requiring Intubation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 710 type: ESTIMATED name: First intubation attempt with endotracheal tube plus bougie name: First intubation attempt with endotracheal tube alone measure: Number of first pass success during prehospital emergency intubation measure: Occurrence of hypoxia measure: Occurrence of bradycardia measure: Occurrence of cardiac arrest measure: Occurrence of death measure: Occurrence of pulmonary aspirations measure: Occurrence of severe cardiovascular collapse measure: Time between blade introduction to the confirmation of a correct tube placement 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 measure: Occurrence of change in SpO2 of more than 3% from the time of induction to 2 minutes after confirmation of correct tube placement measure: Cormack-Lehane grade of glottic view at first intubation attempt measure: Number of laryngoscopies attempts to achieve correct endotracheal tube placement measure: Number of patients for whom the placement of an endotracheal tube was not possible in the pre-hospital setting measure: Difficulty perceived by the operator on first intubation attempt measure: Occurrence of injuries measure: Occurrence of complications 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 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nantes University Hospital status: RECRUITING city: Nantes state: Loire Atlantique zip: 44093 country: France name: Quentin Le Bastard, MD role: CONTACT phone: 0240087839 email: quentin.lebastard@chu-nantes.fr name: Quentin Le Bastard, MD role: PRINCIPAL_INVESTIGATOR lat: 47.21725 lon: -1.55336 hasResults: False