Clinical trial 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngoscopy
Keywords: MacGrath MAC
curarization
intubation
MacIntosh
laryngoscope
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful first attempt intubation after curarization
timeFrame: 2 minutes
Secondary outcomes:
measure: Presence of glottal exposure during the first laryngoscopy
timeFrame: 2 minutes
measure: Use of a second laryngoscopy
timeFrame: 2 minutes
measure: Type of laryngoscope used in second laryngoscopy
timeFrame: 2 minutes
measure: Use of a mandrel
timeFrame: 2 minutes
measure: Use of a supra-glottal device
timeFrame: 2 minutes
measure: Use of a fibreoptic
timeFrame: 2 minutes
measure: Use of a transtracheal oxygenation device
timeFrame: 2 minutes
measure: Presence of desaturations <92% during laryngoscopy
timeFrame: 2 minutes
measure: number of esophageal intubation
timeFrame: 2 minutes
measure: Pharyngeal lesions / bleeding
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Chartres
country: France
facility: Chartres Hospital Center
city: Orléans
country: France
facility: Orleans Hospital Center
Study officials:
affiliation: ORLEANS REGIONAL HOSPITAL CENTER
name: MFAM Willy Serge, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHARTRES HOSPITAL CENTER
name: SINDA Patrick, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.