Clinical trial NCT06307392: Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation (BETA Trial)
Official title: Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation in Patients Without Predictors of Difficult Intubation (BETA Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Respiratory Failure Requiring Intubation
Keywords: Bougie
Intubation
Acute Respiratory failure
Airway
Critical Care
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 710
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of first pass success during prehospital emergency intubation
timeFrame: Within 10 minutes following blade introduction
Secondary outcomes:
measure: Occurrence of hypoxia
timeFrame: Within 1 hour following intubation
measure: Occurrence of bradycardia
timeFrame: Within 1 hour following intubation
measure: Occurrence of cardiac arrest
timeFrame: Within 1 hour following intubation
measure: Occurrence of death
timeFrame: Within 1 hour following intubation
measure: Occurrence of pulmonary aspirations
timeFrame: Within 1 hour following intubation
measure: Occurrence of severe cardiovascular collapse
timeFrame: Within 1 hour following intubation
measure: Time between blade introduction to the confirmation of a correct tube placement
timeFrame: Within 15 minutes following blade introduction
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
timeFrame: Within 15 minutes following induction
measure: Occurrence of change in SpO2 of more than 3% from the time of induction to 2 minutes after confirmation of correct tube placement
timeFrame: Within 15 minutes following induction
measure: Cormack-Lehane grade of glottic view at first intubation attempt
timeFrame: Within 10 minutes following first blade introduction
measure: Number of laryngoscopies attempts to achieve correct endotracheal tube placement
timeFrame: Within 30 minutes following first blade introduction
measure: Number of patients for whom the placement of an endotracheal tube was not possible in the pre-hospital setting
timeFrame: Within 30 minutes following first blade introduction
measure: Difficulty perceived by the operator on first intubation attempt
timeFrame: Within 10 minutes following blade introduction
measure: Occurrence of injuries
timeFrame: Within 24 hours following intubation
measure: Occurrence of complications
timeFrame: Within 48 hours following intubation
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
timeFrame: Within one hour after confirmation of correct tube placement
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire Atlantique
Study officials:
affiliation: Nantes University Hospital
name: Quentin LE BASTARD, MD
role: PRINCIPAL_INVESTIGATOR
References: