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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,250
- 试验地点
- 4
- 主要终点
- Successful first attempt intubation after curarization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •less than 2 criteria of difficult intubation admitted to the operating theater for scheduled surgery requiring orotracheal intubation after curarization - informed consent
排除标准
- •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
结局指标
主要结局
Successful first attempt intubation after curarization
时间窗: 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.
次要结局
- number of esophageal intubation(2 minutes)
- Type of laryngoscope used in second laryngoscopy(2 minutes)
- Use of a supra-glottal device(2 minutes)
- Presence of desaturations <92% during laryngoscopy(2 minutes)
- Pharyngeal lesions / bleeding(2 minutes)
- Presence of glottal exposure during the first laryngoscopy(2 minutes)
- Use of a second laryngoscopy(2 minutes)
- Use of a mandrel(2 minutes)
- Use of a fibreoptic(2 minutes)
- Use of a transtracheal oxygenation device(2 minutes)