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)

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.

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.

Study Overview

• Status: Completed
• Conditions: Laryngoscopy
• Intervention / Treatment: Device: Laryngoscopy with Mac Grath; Device: direct laryngoscopy

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.

• Study Type: Interventional
• Enrollment (Actual): 1250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Chartres, France, 28630
    • Chartres Hospital Center
  • Orléans, France, 45067
    • Orleans Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MacGrath MAC video laryngoscopy; Patients will benefit MacGrath MAC video laryngoscopy for intubation after curarization	Device: Laryngoscopy with Mac Grath; Patients of this group will benefit MacGrath MAC video laryngoscopy for intubation after curarization
ACTIVE_COMPARATOR: direct laryngoscopy; Patients will benefit direct laryngoscopy for intubation after curarization	Device: direct laryngoscopy; Patients of this group will benefit direct laryngoscopy for intubation after curarization

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Principal Investigator: MFAM Willy Serge, MD, ORLEANS REGIONAL HOSPITAL CENTER; Principal Investigator: SINDA Patrick, MD, Chartres Hospital Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2018
• Primary Completion (ACTUAL): September 23, 2019
• Study Completion (ACTUAL): September 23, 2019

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 13, 2018
• First Posted (ACTUAL): March 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: intubation; laryngoscope; MacGrath MAC; curarization; MacIntosh
• Other Study ID Numbers: CHRO-2017-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No