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.

Laryngoscopy Clinical Trial

— MILAR  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470116
• Other study ID #: CHRO-2017-13
• Status: Completed
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: September 23, 2019

Study information

• Verified date: March 2020
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1250
• Est. completion date: September 23, 2019
• Est. primary completion date: September 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Laryngoscopy

Intervention

Device:
• Laryngoscopy with Mac Grath
Patients of this group will benefit MacGrath MAC video laryngoscopy for intubation after curarization
• direct laryngoscopy
Patients of this group will benefit direct laryngoscopy for intubation after curarization

Locations

Country	Name	City	State
France	Chartres Hospital Center	Chartres
France	Orleans Hospital Center	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View 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. — View Citation

Kaplan A, Göksu E, Yildiz G, Kiliç 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. — View Citation

Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. — View 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. — View 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. — View Citation

Outcome

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