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.
- Conditions
- Laryngoscopy
- Interventions
- Device: Laryngoscopy with Mac GrathDevice: direct laryngoscopy
- Registration Number
- NCT03470116
- Lead Sponsor
- Centre Hospitalier Régional d'Orléans
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1250
less than 2 criteria of difficult intubation admitted to the operating theater for scheduled surgery requiring orotracheal intubation after curarization - informed consent
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MacGrath MAC video laryngoscopy Laryngoscopy with Mac Grath Patients will benefit MacGrath MAC video laryngoscopy for intubation after curarization direct laryngoscopy direct laryngoscopy Patients will benefit direct laryngoscopy for intubation after curarization
- Primary Outcome Measures
Name Time Method Successful first attempt intubation after curarization 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 Outcome Measures
Name Time Method number of esophageal intubation 2 minutes Type of laryngoscope used in second laryngoscopy 2 minutes If second laryngoscopy is practice, name of second laryngoscope
Use of a supra-glottal device 2 minutes Use or not of a supra-glottal device
Presence of desaturations <92% during laryngoscopy 2 minutes presence or absence of desaturation
Pharyngeal lesions / bleeding 2 minutes Presence of glottal exposure during the first laryngoscopy 2 minutes presence or absence of glottal exposure during the first laryngoscopy
Use of a second laryngoscopy 2 minutes Use or not of a second laryngoscopy
Use of a mandrel 2 minutes use or not of a mandrel
Use of a fibreoptic 2 minutes Use or not of a fibreoptic
Use of a transtracheal oxygenation device 2 minutes Use or not of a transtracheal oxygenation device
Trial Locations
- Locations (2)
Chartres Hospital Center
🇫🇷Chartres, France
Orleans Hospital Center
🇫🇷Orléans, France