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

Acute Respiratory Failure Requiring Intubation Clinical Trial

— BETA  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06307392
• Other study ID #: RC22_0393
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: April 2024
• Source: Nantes University Hospital
• Contact: Quentin LE BASTARD, MD
• Phone: 0240087839
• Email: quentin.lebastard[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 710
• Est. completion date: March 31, 2027
• Est. primary completion date: March 26, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Failure Requiring Intubation
• Emergencies
• Respiratory Insufficiency

Intervention

Procedure:
• First intubation attempt with endotracheal tube plus bougie
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 alone
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

Country	Name	City	State
France	Nantes University Hospital	Nantes	Loire Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of first pass success during prehospital emergency intubation	Successful intubation on first attempt	Within 10 minutes following blade introduction
Secondary	Occurrence of hypoxia	SpO2 (pulsed oxygen saturation) <90%	Within 1 hour following intubation
Secondary	Occurrence of bradycardia	Heart rate <50 bpm	Within 1 hour following intubation
Secondary	Occurrence of cardiac arrest		Within 1 hour following intubation
Secondary	Occurrence of death		Within 1 hour following intubation
Secondary	Occurrence of pulmonary aspirations		Within 1 hour following intubation
Secondary	Occurrence of severe cardiovascular collapse	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	Within 1 hour following intubation
Secondary	Time between blade introduction to the confirmation of a correct tube placement	In minutes. The correct position of the endotracheal tube is confirmed by detection of end-tidal carbon dioxide.	Within 15 minutes following blade introduction
Secondary	Change in SpO2 (pulsed oxygen saturation) from the time of induction to lowest SpO2 up to 2 minutes after confirmation of correct tube placement	In percentage	Within 15 minutes following induction
Secondary	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
Secondary	Cormack-Lehane grade of glottic view at first intubation attempt		Within 10 minutes following first blade introduction
Secondary	Number of laryngoscopies attempts to achieve correct endotracheal tube placement		Within 30 minutes following first blade introduction
Secondary	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
Secondary	Difficulty perceived by the operator on first intubation attempt	3-point Likert scale	Within 10 minutes following blade introduction
Secondary	Occurrence of injuries	Occurrence (yes/no) of injuries related to the intubation: mucosal bleeding, laryngeal, tracheal, bronchial, mediastinal or oesophageal injuries	Within 24 hours following intubation
Secondary	Occurrence of complications	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)	Within 48 hours following intubation
Secondary	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	SpO2/FiO2 collected every 10 minutes to determine the minimum ratio	Within one hour after confirmation of correct tube placement