Estimation of the Non-Inferiority of the Laringocel® Videolaryngoscope Compared With the C-MAC D-BLADE (Karl Storz®) for First-Attempt Intubation in Adult Patients Undergoing Elective Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- First-attempt orotracheal intubation success
研究概览
简要总结
This study will test two video laryngoscopes that help doctors place a breathing tube during surgery. A breathing tube is needed for people who receive general anesthesia so they can breathe safely. Video laryngoscopes use a small camera to give a better view of the throat and vocal cords, which may help the tube go in on the first try.
The purpose of this research is to find out if a Colombian device called Laringocel® works as well as the widely used international device C-MAC D-Blade® (Karl Storz). If Laringocel® performs similarly, it could be a more affordable option for hospitals with limited resources.
252 adults (126 in each group) who need elective surgery at Alma Máter Hospital de Antioquia (Medellín, Colombia) will take part. Each participant will be randomly assigned, like flipping a coin, to have their breathing tube placed with either Laringocel® or C-MAC D-Blade®. Only trained anesthesiologists will perform the procedure.
The study will look at:
Main goal: how often the tube goes in correctly on the first attempt.
Other goals: overall success within 3 attempts, how well the airway is seen, how long the intubation takes, how satisfied the doctor is with the device, and possible side effects such as sore throat, dental injury, or oral injury.
Participation will not change the usual care people receive during anesthesia. Both devices are already approved for clinical use. Risks are the same as with any standard intubation, and participants will be checked after surgery for any problems.
By comparing these two devices, researchers hope to learn if Laringocel® can provide safe and effective intubation at lower cost, improving access to advanced airway tools.
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
- Double (Participant, Outcomes Assessor)
盲法说明
the person who generated the randomization sequence is independent from patient recruitment, intervention, and outcome assessment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years of age or older
- •Patients scheduled for elective surgery under general anesthesia
- •Patients requiring single-lumen orotracheal intubation
- •Patients compliant with the anesthetic indication and standard preoperative fasting requirements
排除标准
- •Patients with an anticipated difficult airway (more than two anatomical risk factors for difficult airway)
- •Patient refusal to participate in the study via informed consent
结局指标
主要结局
First-attempt orotracheal intubation success
时间窗: During the intubation procedure (intraoperative, immediately after induction of anesthesia)
Proportion of participants with successful tracheal intubation on the first attempt, defined as correct placement of the endotracheal tube confirmed by continuous capnography. A successful attempt is one in which the videolaryngoscope is introduced and removed only once, without requiring a second attempt, device change, or external assistance.
次要结局
- Overall orotracheal intubation success within three attempts(During the intubation procedure (intraoperative, immediately after induction of anesthesia))
- Percentage of Glottic Opening (POGO) score(During the intubation procedure (intraoperative, immediately after induction of anesthesia))
- Operator satisfaction(Immediately after the intubation procedure (intraoperative period))
- Team situation awareness (SAGAT method)(Immediately after the intubation procedure (intraoperative period))
- Overall orotracheal intubation success within three attempts(During the intubation procedure (intraoperative, immediately after induction of anesthesia))
- Percentage of Glottic Opening (POGO) score(During the intubation procedure (intraoperative, immediately after induction of anesthesia))
- Fremantle score(During the intubation procedure (intraoperative, immediately after induction of anesthesia).)
- Intubation time(During the intubation procedure (intraoperative, immediately after induction of anesthesia))
- Operator satisfaction(Immediately after the intubation procedure (intraoperative period))
- Team situation awareness (SAGAT method)(Immediately after the intubation procedure (intraoperative period))
- Adverse events related to intubation(One hour after extubation (post-anesthesia care unit or intensive care unit))
研究者
Mario Zamudio
University professor with a master's degree in clinical epidemiology
Universidad de Antioquia