Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation (BETA Trial)

Nantes University Hospital710 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

710

Conditions

Acute Respiratory Failure Requiring Intubation

Interventions

First intubation attempt with endotracheal tube plus bougiePROCEDURE

Use of a straight, malleable, semirigid bougie on first-attempt intubation. The required bougie is at least 60cm length, a coudé tip is recommended but not required. Operator may choose whether to bend the bougie prior to intubation. During laryngoscopy, the operator will insert the bougie into the trachea under direct or indirect visual control. If the bougie is successfully placed in the trachea, an assistant will load the endotracheal tube directly over the bougie while the operator will manually stabilize the bougie. Once the bougie has reached the mouth, the assistant will then stabilize the bougie, and the operator will advance the tube through the vocal cords to the adequate depth in the trachea, without removing the laryngoscope from the mouth. The operator will inflate the cuff and manually stabilize the tube. Then, the assistant will withdraw the bougie from the endotracheal tube. The use of a stylet is not permitted.

First intubation attempt with endotracheal tube alonePROCEDURE

During laryngoscopy, the operator will insert the endotracheal tube alone into the trachea under direct or indirect visual control. The operator will advance the tube through the vocal cords to the adequate depth in the trachea, without removing the laryngoscope from the mouth. The operator will inflate the cuff and manually stabilize the tube. The use of a stylet is not permitted.

Locations (10)

Nantes University Hospital

Nantes, Loire Atlantique, France

RECRUITING

CHU de Besançon

Besançon, France

RECRUITING

CHU de Bordeaux

Bordeaux, France

RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

CHD La Roche sur Yon

La Roche-sur-Yon, France

RECRUITING

CH de Lorient

Lorient, France

NOT_YET_RECRUITING

CHU de Lyon

Lyon, France

NOT_YET_RECRUITING

CHU de Nancy

Nancy, France

RECRUITING

CHU de Poitiers

Poitiers, France

RECRUITING

CHU de Rennes

Rennes, France

RECRUITING

Outcomes

Primary Outcomes

Number of first pass success during prehospital emergency intubation

Successful intubation on first attempt

Time frame: Within 10 minutes following blade introduction