Comparison of Videolaryngoscope and VideoLMA for Endotracheal Intubation in Patients Undergoing Retrograde Intrarenal Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intubation Time
研究概览
简要总结
This study is a prospective, randomized, parallel-group clinical trial comparing videolaryngoscope and videoLMA for endotracheal intubation in adult patients undergoing surgery. Patients will be randomly assigned into two groups. The primary outcome is intubation time. Secondary outcomes include first attempt success rate, number of attempts, oxygen desaturation, hemodynamic changes, and postoperative complications.
详细描述
Airway management is a critical component of anesthesia practice. Videolaryngoscopes and videoLMA devices are widely used tools for endotracheal intubation. While videolaryngoscopes provide improved visualization of the glottis, videoLMA devices can facilitate both airway management and guided intubation.
In this prospective randomized study, 100 patients will be assigned to either videolaryngoscope or videoLMA groups. Standard anesthesia induction will be applied. Intubation time, success rates, hemodynamic responses, and complications will be recorded and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
this study is conducted as an open label trial no masking is applied the clinicians performing the intubation and collecting the data are aware of the intervention
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
- •Adults aged 18 years and older ASA physical status I-III Patients scheduled for surgery requiring endotracheal intubation Ability to provide written informed consent
排除标准
- •History of tracheostomy Known or predicted difficult airway Presence of oral mass or tumor Pregnant patients Patients unable to provide informed consent Patients requiring reoperation within 24 hours
研究组 & 干预措施
Videolaryngoscope Group
Patients undergoing endotracheal intubation using videolaryngoscope
干预措施: Videolaryngoscope (Device)
VideoLMA Group
Patients undergoing endotracheal intubation using videoLMA
干预措施: VideoLMA (Device)
结局指标
主要结局
Intubation Time
时间窗: From insertion of the airway device to confirmation of endotracheal tube placement (during anesthesia induction, within approximately 0-5 minutes)
Time from insertion of the airway device into the patient's mouth until successful placement of the endotracheal tube, confirmed by continuous capnography.
次要结局
- First Attempt Success(During first intubation attempt (within 0-2 minutes))
- Number of Attempts(During intubation procedure (within approximately 0-10 minutes)
- Oxygen Desaturation(During intubation procedure (from induction until successful intubation, approximately 0-10 minutes))
- Heart rate(At baseline (pre-induction), immediately after intubation, and at 1, 3, and 5 minutes post-intubation)
- Postoperative Sore Throat(At postoperative 1 hour and 2 hours)
- Hoarseness(At postoperative 1 hour and 2 hours)
- Complications(During intubation and intraoperative period (approximately 0-60 minutes))
- mean arterial pressure(baseline, post intubation,1,3,5 min)
研究者
Ela Erdem Hıdiroglu
MD, Specialist in Anesthesiology and Reanimation
Ankara Etlik City Hospital