Visual Versus Conventional Intubation: Comparison of SaCoVLM™ Video Laryngeal Mask and Direct Laryngoscopy : A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Change in Mean Arterial Pressure During Intubation
研究概览
简要总结
This is a prospective, observational study designed to evaluate airway management techniques used during elective surgery under general anesthesia. The study focuses on perioperative hemodynamic parameters and airway-related procedural characteristics.
详细描述
Study Design This is a single-center, prospective, observational study conducted at Akdeniz University Hospital after approval by the Institutional Ethics Committee (Approval No: 70904504/139). Written informed consent was obtained from all participants prior to enrollment.
Participants Adult patients scheduled for elective surgery under general anesthesia between March and June 2024 were screened for inclusion.
Exclusion Criteria Patients were excluded if they were under 18 years of age, pregnant, had known hypersensitivity to anesthetic agents, gastroesophageal reflux disease, or active upper respiratory tract infection.
Group Allocation and Airway Management
Due to the observational design of the study, randomization was not performed. Patients were allocated to groups according to the airway management technique selected by the attending anesthesiologist:
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
- •Age ≥ 18 years
- •Scheduled for elective surgery under general anesthesia
- •Requires tracheal intubation as part of the planned anesthetic technique
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Able to provide written informed consent
排除标准
- •Age < 18 years
- •Known or suspected hypersensitivity to anesthetic agents used in the protocol
- •History of gastroesophageal reflux disease or increased risk of aspiration
- •Active upper respiratory tract infection
- •Predicted difficult airway (Mallampati class IV, mouth opening < 3 cm, limited neck mobility)
- •Severe cardiopulmonary instability
- •Emergency surgery
- •Upper airway pathology (airway trauma, tumor, edema, infection)
- •Coagulopathy or bleeding tendency
- •Inability to cooperate or provide informed consent
研究组 & 干预措施
Group 1: SaCoVLM™ Video Laryngeal Mask Group 2: Direct Laryngoscopy
Group 1: SaCoVLM™ Video Laryngeal Mask (VLM), "Intubation performed using SaCoVLM™ video laryngeal mask under general anesthesia."
Group 2: Direct Laryngoscopy (DL),: "Intubation performed using direct laryngoscopy under general anesthesia."
结局指标
主要结局
Change in Mean Arterial Pressure During Intubation
时间窗: Baseline (pre-induction) and 1 minute after endotracheal tube placement
Mean arterial pressure (MAP) measured non-invasively at baseline (before induction of anesthesia) and at 1 minute after successful endotracheal tube placement.
次要结局
- First-Attempt Intubation Success(During airway instrumentation (peri-procedural) Unit of Measure Percentage (%))
- Heart Rate Response to Intubation(Baseline (pre-induction) and 1 minute after endotracheal tube placement Unit of Measure beats per minute)
- Oxygen Saturation During Airway Management(Baseline and during airway instrumentation Unit of Measure Percentage (%))
研究者
Emel Gunduz
Associate Professor of Anesthesiology, Akdeniz University, Antalya, Turkey
Akdeniz University