A Multicenter, Prospective, Randomized, Single-blind Study Comparing Direct Laryngoscopy and Videolaryngoscopy for Orotracheal Intubation Performed by Anesthesia Residents in the Operating Room
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,008
- 试验地点
- 9
- 主要终点
- Difference in the first attempt success rate (percentage)
研究概览
简要总结
The usual intubation technique in the operating room is based on direct laryngoscopy, using a standard Macintosh laryngoscope. However, this skill is not easy to acquire and requires adecuate training. Videolaryngoscopes are becoming a widely accepted airway management technique. because offer better view of the glottis and are easy to use. In addition, indirect laryngoscopes are useful for tracheal intubation by novice operators because of the feedback that supervisors can offer during intubation.
The goal of this clinical trial is to learn which intubation technique performed by residents of anesthesia in the operating room is better.
The main questions it aims to answer are:
- Which intubation technique is more effective for achieving first-attempt intubation?
- Which intubation technique results in fewer complications? Researchers will compare both intubation techniques performed by anesthesia residents in the operating room in adult anesthesia cases.
详细描述
The study will randomize, by means of a computer-generated randomization, approximately 1008 adults in two groups: Conventional group (Laryngoscope with Macintosh Blade) and Videolaryngoscope group (Mac-Style Blade) to be intubated in the operating room by an anesthesia resident.
Success rate of the selected technique (first attempt), overall success rate, number of attempts, complications, and duration of insertion for technique will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Patients who need to be tracheal intubated for a surgical intervention in the surgical area.
- •Intubation performed by an anesthesia resident.
排除标准
- •Need for tracheal intubation with a device other than videolaryngoscopy or direct laryngoscopy (fiberoptic bronchoscope, tracheostomy...).
- •Context of a Difficult Airway Management.
- •Refusal of the patient
研究组 & 干预措施
Laryngoscope Group
For patients assigned to the Laryngoscope Group, the operator will use a Macintosh laryngoscope for the first laryngoscopy attempt
干预措施: Intubation with standard laryngoscope (Device)
Videolaryngoscope Group
For patients assigned to the Videolaryngoscope Group, the operator will use a videolaryngoscope with Mac-Style Blade for the first laryngoscopy attempt
干预措施: Intubation with video laryngoscope (Device)
结局指标
主要结局
Difference in the first attempt success rate (percentage)
时间窗: During intubation
Success on the first attempt is defined as successfully passing the tube through the vocal cords in a single laryngoscopy attempt and inserting the endotracheal tube into the trachea
次要结局
- Need for additional airway equipment(During intubation)
- Comparing the glottic view in the modified Cormack-Lehane scale between the two approaches(During intubation)
- Difference in percentage of "easy intubation"(During intubation)
- Duration of laryngoscopy and tracheal intubation(During intubation)
- Number of attempts to cannulate the trachea with an endotracheal tube(During intubation)
- Number of attempts to cannulate the trachea with a bougie.(During intubation)
- Need to change the device for intubation(During intubation)
- Operator-assessed difficulty of intubation(During intubation)
- Use of external laryngeal pressure(During intubation)
- Complications during intubation(Participants will be followed from the beginning of the intervention to 10 minutes after the intervention)
- Reason for failure to intubate on the first attempt(During intubation)
研究者
Maria Bermudez Lopez
Principal Investigator
Hospital Universitario Lucus Augusti