VISION - Non-Inferiority of videolaryngoscopy-assisted intubation without neuromuscular blockade versus with neuromuscular blockade on first-attempt intubation success free of major complications: a randomized clinical trial

Condition studied

Adult patients requiring elective general anaesthesia with tracheal intubation for a surgical procedure requiring a neuromuscular blocking agent to ease the surgery.

Investigational medicinal product(s)

Every trial of Atracurium across our registers →

Eligibility

Primary endpoint

The success of intubation at first attempt is defined as the placement of an endotracheal tube in the trachea with a single use of a VL (with use of a bougie or not), by the presence of 3 cycles of adequate ventilation, exhaled CO2 curves, and symmetrical pulmonary auscultation.

Endpoint detail

(1) Tracheal intubation success at the first attempt, free of major complications;, (2) Number of tracheal intubation attempts;, (3) Mean POGO (percentage of glottic opening) score and mean Cormack-Lehane score, (4) Tracheal intubation success at first attempt within 10 minutes after initiation of intubation maneuvres according to VLs types;, (5) Intubation Difficulty Score, (6) Desaturation defined as any SpO2<95% within 10 minutes after initiation of intubation maneuvres;, (7) Occurrence of cardiac arrhythmia requiring therapeutic intervention to reduce or terminate the arrythmia (e.g., administration of antiarrhythmic drugs, electrical cardioversion, or discontinuation of the triggering agent), of sustained cardiac arrhythmia lasting more than 30 seconds, or of cardiac arrest, within 10 minutes after initiation of intubation maneuvres;, (8) Occurrence of airway-related complication defined as dental injury, oropharyngeal trauma, mucosal bleeding, lip or gum laceration after successful tracheal intubation within 10 minutes after initiation of intubation manoeuvres or a postoperative sore throat (throat pain) or hoarseness of voice evaluated at day 1;, (9) Difficult intubation within 10 minutes after initiation of intubation manoeuvres, defined by at least one of the following: the need for optimization maneuvers (including external laryngeal pressure, stylet or bougie), the use of an alternative intubation rescue methods; or an Intubation Difficulty Scale score above 5, (10) Incidence of atracurium-related anaphylaxis occurring within 10 minutes of investigational atracurium administration in the VL/atracurium group. No between-group treatment effect will be estimated