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.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Laryngoscopy

Intervention / Treatment
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* Device: Laryngoscopy with Mac Grath
* Device: direct laryngoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: less than 2 criteria of difficult intubation admitted to the operating theater for scheduled surgery requiring orotracheal intubation after curarization - informed consent Exclusion Criteria: pregnancy age < 18 contraindication to oro-tracheal intubation emergency surgery thoracic surgery naso-tracheal intubation patient protected by law patient not affiliated to french social security BMI> 45kg / m² Predicted patient with difficult intubation Patients considered to be predisposed to difficult intubation are those with a history of difficult intubation, or with 2 criteria among: Mallampati 3 or 4 Thyroid-chin distance <65mm Mouth opening <35mm Spinal extension less than 90 ° Retrognathism with Negative Lip Test Morbid obesity with BMI> 35kg / m² Obstructive Sleep Apnea Syndrome with choker> 45cm Diabetic with sign of the positive prior Head and Neck Pathology

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MacGrath MAC video laryngoscopy<br>Patients will benefit MacGrath MAC video laryngoscopy for intubation after curarization | Device: Laryngoscopy with Mac Grath<br>* Patients of this group will benefit MacGrath MAC video laryngoscopy for intubation after curarization<br>|
| Active Comparator: direct laryngoscopy<br>Patients will benefit direct laryngoscopy for intubation after curarization | Device: direct laryngoscopy<br>* Patients of this group will benefit direct laryngoscopy for intubation after curarization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of glottal exposure during the first laryngoscopy | presence or absence of glottal exposure during the first laryngoscopy | 2 minutes | 
| Use of a second laryngoscopy | Use or not of a second laryngoscopy | 2 minutes | 
| Type of laryngoscope used in second laryngoscopy | If second laryngoscopy is practice, name of second laryngoscope | 2 minutes | 
| Use of a mandrel | use or not of a mandrel | 2 minutes | 
| Use of a supra-glottal device | Use or not of a supra-glottal device | 2 minutes | 
| Use of a fibreoptic | Use or not of a fibreoptic | 2 minutes | 
| Use of a transtracheal oxygenation device | Use or not of a transtracheal oxygenation device | 2 minutes | 
| Presence of desaturations <92% during laryngoscopy | presence or absence of desaturation | 2 minutes | 
| number of esophageal intubation |  | 2 minutes | 
| Pharyngeal lesions / bleeding |  | 2 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MacGrath MAC, curarization, intubation, MacIntosh, laryngoscope