NCT03470116

Comparison Between the MacGrath MAC Videolaryngoscope and the MacIntosh Laryngoscope for Oro-tracheal Intubation for Patients With Less Than 2 Criteria of Difficult Intubation in Elective Surgery.

MILAR, is a Controlled, Randomised, Comparative, Prospective, Multi-center, Superiority French Clinical Trial Comparing the MacGrath MAC Videolaryngoscope and the MacIntosh Laryngoscope for Oro-tracheal Intubation by Patients With Less Than 2 Criteria of Difficult Intubation in Elective Surgery.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,250 (actual)
• Sponsor: Centre Hospitalier Régional d'Orléans · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Laryngoscopy

Interventions

Type	Name	Description
DEVICE	Laryngoscopy with Mac Grath	Patients of this group will benefit MacGrath MAC video laryngoscopy for intubation after curarization
DEVICE	direct laryngoscopy	Patients of this group will benefit direct laryngoscopy for intubation after curarization

Timeline

• Start date: 2018-03-20
• Primary completion: 2019-09-23
• Completion: 2019-09-23
• First posted: 2018-03-19
• Last updated: 2020-03-25

Locations

2 sites across 1 country: France