Laryngoscopy with Mac Grath
DevicePatients of this group will benefit MacGrath MAC video laryngoscopy for intubation after curarization
NCT Number: NCT03470116
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.
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Chartres Hospital Center, Chartres, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Patients considered to be predisposed to difficult intubation are those with a history of difficult intubation, or with 2 criteria among:
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
Time frame: 2 minutes
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 or absence of glottal exposure during the first laryngoscopy
Time frame: 2 minutes
Use or not of a second laryngoscopy
Time frame: 2 minutes
If second laryngoscopy is practice, name of second laryngoscope
Time frame: 2 minutes
use or not of a mandrel
Time frame: 2 minutes
Use or not of a supra-glottal device
Time frame: 2 minutes
Use or not of a fibreoptic
Time frame: 2 minutes
Use or not of a transtracheal oxygenation device
Time frame: 2 minutes
presence or absence of desaturation
Time frame: 2 minutes
Time frame: 2 minutes
Centre Hospitalier Régional d'Orléans
Other
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.
Acronym: MILAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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