Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation in Patients Without Predictors of Difficult Intubation (BETA Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Nantes University Hospital
- Enrollment
- 710
- Locations
- 10
- Primary Endpoint
- Number of first pass success during prehospital emergency intubation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Managed by a physician staffed mobile intensive care unit (MICU).
- •With an indication of emergency prehospital endotracheal intubation.
Exclusion Criteria
- •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.
Arms & Interventions
Endotracheal tube plus bougie
Intervention: First intubation attempt with endotracheal tube plus bougie (Procedure)
Endotracheal tube alone
Intervention: First intubation attempt with endotracheal tube alone (Procedure)
Outcomes
Primary Outcomes
Number of first pass success during prehospital emergency intubation
Time Frame: Within 10 minutes following blade introduction
Successful intubation on first attempt
Secondary Outcomes
- 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)
- 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)
- Occurrence of bradycardia(Within 1 hour following intubation)
- Occurrence of pulmonary aspirations(Within 1 hour following intubation)
- Occurrence of severe cardiovascular collapse(Within 1 hour following intubation)
- Time between blade introduction to the confirmation of a correct tube placement(Within 15 minutes following blade introduction)
- 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)
- 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 of complications(Within 48 hours following intubation)
- 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)