A Prospective Observational Study Comparing Tracheal Intubation Via Video Laryngeal Mask Airway and Video Laryngoscope in Adult Patients Undergoing Elective Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Time to Successful Intubation
研究概览
简要总结
This study compares two airway devices that are commonly used during elective surgery: the video laryngeal mask airway (VLM) and the video laryngoscope (VLS). Both are part of routine anesthesia practice. Our main focus is to measure how long intubation takes with each device and to see how successful the intubation is. The study does not involve any extra procedures or risks; everything will be carried out as part of normal patient care.
详细描述
In this prospective observational study, we will compare two airway devices commonly used during elective surgeries: the video laryngeal mask airway (SaCoVLM) and the video laryngoscope. The study will involve adult patients (18 years and older, ASA physical status I-III) scheduled to undergo surgery under general anesthesia at Samsun University Training and Research Hospital.
Patients will be assigned to one of two groups. In one group, intubation will be performed using a video laryngoscope; in the other group, a video laryngeal mask will be used. In both groups, tracheal intubation will be carried out with the assistance of a bougie after device placement.
The primary outcome of the study will be intubation time, defined as the duration from insertion of the device until successful confirmation of tracheal intubation. Secondary outcomes will include ease of insertion, the need for additional maneuvers, and complications such as desaturation, trauma, or failed attempts.
Since both techniques, as well as bougie use, are already part of routine anesthesia practice, no extra interventions or risks will be introduced. The aim of the study is to compare the performance of these two devices under everyday clinical conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients aged 18 years and older
- •Patients scheduled for elective surgical procedures
- •Patients classified as ASA Physical Status I-III
- •Patients undergoing general anesthesia
排除标准
- •Patients younger than 18 years
- •Patients undergoing emergency surgery
- •Patients with difficult airway predictors, such as:
- •Mallampati score ≥ 3
- •Thyromental distance < 6 cm
- •Mouth opening < 3 cm
- •Patients with anatomical abnormalities or surgical history involving the oropharynx, larynx, or airway
- •Patients with conditions contraindicating head or neck manipulation (e.g., cervical instability, upper airway tumors)
- •Pregnant patients
结局指标
主要结局
Time to Successful Intubation
时间窗: Intraoperative (from tube passing the upper incisors to the third ETCO₂ waveform)
The time from when the endotracheal tube passes the upper incisors to the appearance of three consecutive end-tidal CO₂ (ETCO₂) waveforms on the capnograph. This will be used as the objective marker of successful tracheal intubation. Timing will be recorded in seconds by an independent observer using a stopwatch.
次要结局
- First-Attempt Intubation Success Rate(Immediately after intubation)
- Insertion-Related Complications(Intraoperative and early postoperative period (0-30 minutes))