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.

NCT03470116 | Completed

• 1 other identifier: CHRO-2017-13
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 2

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.

Conditions

Laryngoscopy

Keywords

MacGrath MAC; curarization; intubation; MacIntosh; laryngoscope

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Presence of glottal exposure during the first laryngoscopy

  2 minutes

• Use of a second laryngoscopy

  2 minutes

• Type of laryngoscope used in second laryngoscopy

  2 minutes

• Use of a mandrel

  2 minutes

• Use of a supra-glottal device

  2 minutes

Study Arms (2)

MacGrath MAC video laryngoscopy

EXPERIMENTAL

Patients will benefit MacGrath MAC video laryngoscopy for intubation after curarization

Device: Laryngoscopy with Mac Grath

direct laryngoscopy

ACTIVE COMPARATOR

Patients will benefit direct laryngoscopy for intubation after curarization

Device: direct laryngoscopy

Interventions

Laryngoscopy with Mac Grath DEVICE

Patients of this group will benefit MacGrath MAC video laryngoscopy for intubation after curarization

MacGrath MAC video laryngoscopy

direct laryngoscopy DEVICE

Patients of this group will benefit direct laryngoscopy for intubation after curarization

direct laryngoscopy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• less than 2 criteria of difficult intubation admitted to the operating theater for scheduled surgery requiring orotracheal intubation after curarization - informed consent

You may not qualify if:

• 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 °

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (2)

Chartres Hospital Center

Chartres, 28630, France

Location

Orleans Hospital Center

Orléans, 45067, France

Location

Related 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.

  PMID: 21447489 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.

  PMID: 22542734 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.

  PMID: 15271750 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.

  PMID: 25996773 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.

  PMID: 26725922 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.

  PMID: 26174747 BACKGROUND

MeSH Terms

Interventions

Laryngoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Study Officials

• MFAM Willy Serge, MD

  ORLEANS REGIONAL HOSPITAL CENTER

  PRINCIPAL INVESTIGATOR

• SINDA Patrick, MD

  CHARTRES HOSPITAL CENTER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 19, 2018
• Study Start: March 20, 2018
• Primary Completion: September 23, 2019
• Study Completion: September 23, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)