The MILAR trial is a multicenter randomised , prospective, controlled, single-blind, superiority French clinical trial, with a 1: 1 distribution of patients to compare intubation during the first laryngoscopy between the MacGrath MAC videolaryngoscope and the MacIntosh laryngoscope for patients with less than 2 criteria of difficult intubation in elective surgery.
Tracheal intubation is a common procedure in the operating room to secure the airway in patients receiving muscle relaxants . Two devices are currently used for this purpose with various indications: the French Society of Anesthesia and Resuscitation (SFAR) recommends a direct laryngoscopy with MacIntosh blade in first intention for patients with less than 2 criteria of difficult intubation (ID). The SFAR recommends first-line video laryngoscopy in patients with two or more criteria of difficult intubation. Video laryngoscopy improves glottic vision, difficult intubation score, and intubation success rate at the first attempt, compared to the direct laryngoscopy with a Macintosh blade. Currently, it is estimated that 15% of direct laryngoscopies with a MacIntosh blade result in failure of orotracheal intubation (IOT) on first attempt, whereas tracheal intubation with a video laryngoscopy is a better solution to secure the airway. Our hypothesis in this study is that the MacGrath MAC videolaryngoscope allows to intubate at the first laryngoscopy 91% of patients with less than 2 difficult intubation criteria, against the expected 85% with the MacIntosh blade.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
1,250
Patients of this group will benefit MacGrath MAC video laryngoscopy for intubation after curarization
Patients of this group will benefit direct laryngoscopy for intubation after curarization
Chartres Hospital Center
Chartres, France
Orleans Hospital Center
Orléans, France
Successful first attempt intubation after curarization
The primary endpoint is the success of tracheal intubation by anesthesiologists or registrated nurse anesthetists on exposure to first laryngoscopy, confirmed by three identical capnographic curves on the monitor.
Time frame: 2 minutes
Presence of glottal exposure during the first laryngoscopy
presence or absence of glottal exposure during the first laryngoscopy
Time frame: 2 minutes
Use of a second laryngoscopy
Use or not of a second laryngoscopy
Time frame: 2 minutes
Type of laryngoscope used in second laryngoscopy
If second laryngoscopy is practice, name of second laryngoscope
Time frame: 2 minutes
Use of a mandrel
use or not of a mandrel
Time frame: 2 minutes
Use of a supra-glottal device
Use or not of a supra-glottal device
Time frame: 2 minutes
Use of a fibreoptic
Use or not of a fibreoptic
Time frame: 2 minutes
Use of a transtracheal oxygenation device
Use or not of a transtracheal oxygenation device
Time frame: 2 minutes
Presence of desaturations <92% during laryngoscopy
presence or absence of desaturation
Time frame: 2 minutes
number of esophageal intubation
Time frame: 2 minutes
Pharyngeal lesions / bleeding
Time frame: 2 minutes
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