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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MacGrath MAC video laryngoscopy | Experimental | Patients will benefit MacGrath MAC video laryngoscopy for intubation after curarization |
|
| direct laryngoscopy | Active Comparator | Patients will benefit direct laryngoscopy for intubation after curarization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laryngoscopy with Mac Grath | Device | Patients of this group will benefit MacGrath MAC video laryngoscopy for intubation after curarization |
|
| 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 |
| 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 |
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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:
Patients considered to be predisposed to difficult intubation are those with a history of difficult intubation, or with 2 criteria among:
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| Name | Affiliation | Role |
|---|---|---|
| MFAM Willy Serge, MD | ORLEANS REGIONAL HOSPITAL CENTER | Principal Investigator |
| SINDA Patrick, MD | CHARTRES HOSPITAL CENTER | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chartres Hospital Center | Chartres | 28630 | France | |||
| Orleans Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21447489 | Background | Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42. doi: 10.1093/bja/aer059. Epub 2011 Mar 29. | |
| 22542734 |
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| direct laryngoscopy | Device | Patients of this group will benefit direct laryngoscopy for intubation after curarization |
|
| 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 |
| Orléans |
| 45067 |
| France |
| Background |
| Hasegawa K, Shigemitsu K, Hagiwara Y, Chiba T, Watase H, Brown CA 3rd, Brown DF; Japanese Emergency Medicine Research Alliance Investigators. Association between repeated intubation attempts and adverse events in emergency departments: an analysis of a multicenter prospective observational study. Ann Emerg Med. 2012 Dec;60(6):749-754.e2. doi: 10.1016/j.annemergmed.2012.04.005. Epub 2012 Apr 28. |
| 15271750 | Background | Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15. |
| 25996773 | Background | Sakles JC, Javedani PP, Chase E, Garst-Orozco J, Guillen-Rodriguez JM, Stolz U. The use of a video laryngoscope by emergency medicine residents is associated with a reduction in esophageal intubations in the emergency department. Acad Emerg Med. 2015 Jun;22(6):700-7. doi: 10.1111/acem.12674. Epub 2015 May 20. |
| 26725922 | Background | Kaplan A, Goksu E, Yildiz G, Kilic T. Comparison of the C-MAC Videolaryngoscope and Rigid Fiberscope with Direct Laryngoscopy in Easy and Difficult Airway Scenarios: A Manikin Study. J Emerg Med. 2016 Mar;50(3):e107-14. doi: 10.1016/j.jemermed.2015.06.070. Epub 2015 Dec 22. |
| 26174747 | Background | Ruetzler K, Imach S, Weiss M, Haas T, Schmidt AR. [Comparison of five video laryngoscopes and conventional direct laryngoscopy : Investigations on simple and simulated difficult airways on the intubation trainer]. Anaesthesist. 2015 Jul;64(7):513-9. doi: 10.1007/s00101-015-0051-5. Epub 2015 Jul 15. German. |
| ID | Term |
|---|---|
| D007828 | Laryngoscopy |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013517 | Otorhinolaryngologic Surgical Procedures |
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