Skip to main content
OpenTrials
Completed

NCT Number: 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.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chartres Hospital Center, Chartres, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laryngoscopy with Mac Grath

Device

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

direct laryngoscopy

Device

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

Primary outcomes

  1. Successful first attempt intubation after curarization

    Time frame: 2 minutes

    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.

Secondary outcomes

  1. Presence of glottal exposure during the first laryngoscopy

    Time frame: 2 minutes

    presence or absence of glottal exposure during the first laryngoscopy

  2. Use of a second laryngoscopy

    Time frame: 2 minutes

    Use or not of a second laryngoscopy

  3. Type of laryngoscope used in second laryngoscopy

    Time frame: 2 minutes

    If second laryngoscopy is practice, name of second laryngoscope

  4. Use of a mandrel

    Time frame: 2 minutes

    use or not of a mandrel

  5. Use of a supra-glottal device

    Time frame: 2 minutes

    Use or not of a supra-glottal device

  6. Use of a fibreoptic

    Time frame: 2 minutes

    Use or not of a fibreoptic

  7. Use of a transtracheal oxygenation device

    Time frame: 2 minutes

    Use or not of a transtracheal oxygenation device

  8. Presence of desaturations <92% during laryngoscopy

    Time frame: 2 minutes

    presence or absence of desaturation

  9. number of esophageal intubation

    Time frame: 2 minutes

  10. Pharyngeal lesions / bleeding

    Time frame: 2 minutes

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study 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.

Acronym: MILAR

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2018
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.