Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation (BETA Trial)
- Conditions
- Acute Respiratory Failure Requiring Intubation
- Interventions
- Procedure: First intubation attempt with endotracheal tube plus bougieProcedure: First intubation attempt with endotracheal tube alone
- Registration Number
- NCT06307392
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 710
- Managed by a physician staffed mobile intensive care unit (MICU).
- With an indication of emergency prehospital endotracheal intubation.
- Pregnant women
- Patients with a "not to be resuscitated" indication.
- Patients with predictors of difficult intubation (that can be collected in the prehospital setting, including previous history of face, neck, throat surgery or pathology, limited mandibular protrusion, cervical spine trauma, facial trauma, ear-nose-throat malignancy, head or neck burns, history of previous difficult airways) for whom the use of a bougie is indicated on first intubation attempt.
- Patients under guardianship, trusteeship or safeguard of justice and patients with no health insurance.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endotracheal tube plus bougie First intubation attempt with endotracheal tube plus bougie - Endotracheal tube alone First intubation attempt with endotracheal tube alone -
- Primary Outcome Measures
Name Time Method Number of first pass success during prehospital emergency intubation Within 10 minutes following blade introduction Successful intubation on first attempt
- Secondary Outcome Measures
Name Time Method Occurrence of cardiac arrest Within 1 hour following intubation Occurrence of death Within 1 hour following intubation Number of patients for whom the placement of an endotracheal tube was not possible in the pre-hospital setting Within 30 minutes following first blade introduction Occurrence of hypoxia Within 1 hour following intubation SpO2 (pulsed oxygen saturation) \<90%
Occurrence of change in SpO2 of more than 3% from the time of induction to 2 minutes after confirmation of correct tube placement Within 15 minutes following induction Number of laryngoscopies attempts to achieve correct endotracheal tube placement Within 30 minutes following first blade introduction Difficulty perceived by the operator on first intubation attempt Within 10 minutes following blade introduction 3-point Likert scale
Occurrence of bradycardia Within 1 hour following intubation Heart rate \<50 bpm
Occurrence of pulmonary aspirations Within 1 hour following intubation Occurrence of severe cardiovascular collapse Within 1 hour following intubation Systolic blood pressure less than 65mmHg recorded at least once or less than 90 mmHg lasting 30 minutes despite 500-1,000 ml of fluid loading (crystalloids) or requiring introduction or increasing doses by more than 30% of vasoactive support
Time between blade introduction to the confirmation of a correct tube placement Within 15 minutes following blade introduction In minutes. The correct position of the endotracheal tube is confirmed by detection of end-tidal carbon dioxide.
Change in SpO2 (pulsed oxygen saturation) from the time of induction to lowest SpO2 up to 2 minutes after confirmation of correct tube placement Within 15 minutes following induction In percentage
Cormack-Lehane grade of glottic view at first intubation attempt Within 10 minutes following first blade introduction Occurrence of injuries Within 24 hours following intubation Occurrence (yes/no) of injuries related to the intubation:
mucosal bleeding, laryngeal, tracheal, bronchial, mediastinal or oesophageal injuriesOccurrence of complications Within 48 hours following intubation Occurrence (yes/no) of complications related to the intubation:
aspiration pneumonia (new opacity on chest imaging within 48 hours after intubation, in comparison to the first chest imaging after hospital admission), pneumothorax (new air collection within the pleural cavity on chest imaging)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 Within one hour after confirmation of correct tube placement SpO2/FiO2 collected every 10 minutes to determine the minimum ratio
Trial Locations
- Locations (1)
Nantes University Hospital
🇫🇷Nantes, Loire Atlantique, France