Comparison of Video Laryngeal Mask Airway and Endotracheal Tube Use for Airway Safety in Patients Undergoing Septoplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Glottis/Trachea and Distal Trachea Blood Contamination Scores
研究概览
简要总结
This randomized controlled trial compares a video laryngeal mask airway (VLMA) and an endotracheal tube (ETT) in adult patients undergoing elective septoplasty. The primary objective is to see which device more effectively prevents surgical blood contamination in the glottic and subglottic regions. The study also assesses perioperative hemodynamic stability, ventilation parameters, and postoperative recovery factors such as sore throat, hoarseness, and overall patient comfort. The findings aim to help determine the optimal airway device choice for nasal surgeries.
详细描述
This prospective, randomized controlled trial will compare the efficacy and safety of a video laryngeal mask airway (VLMA) versus a standard endotracheal tube (ETT) for airway management in adult patients (aged 18-65, ASA physical status I-II) undergoing elective septoplasty under general anesthesia.
Participants will be randomly assigned to receive either a video-assisted supraglottic airway (VLMA) or a conventional endotracheal tube (ETT). The primary objective is to evaluate whether VLMA can provide better protection against blood contamination in the glottic and subglottic regions compared to ETT. Secondary objectives include assessments of perioperative hemodynamic stability, respiratory performance, postoperative airway-related complications, and overall recovery.
All patients will undergo standardized anesthesia induction (e.g., propofol plus an opioid) and maintenance with inhalational agents and/or remifentanil infusion. Depth of anesthesia will be monitored using the bispectral index (BIS), along with standard ASA monitoring. Respiratory parameters (tidal volume, end-tidal CO₂, peak and plateau airway pressures) will be recorded throughout the procedure. Hemodynamic data (heart rate, systolic and diastolic arterial pressures) will be measured at predefined time points: pre-induction, post-airway insertion, and post-extubation.
At the end of surgery, blood contamination within the airway will be assessed at two anatomical levels:
Distal trachea: In both groups, a fiberoptic bronchoscope will be used for evaluation. In the ETT group, the bronchoscope will be inserted through the endotracheal tube before removal. In the VLMA group, the bronchoscope will be passed through the lumen of the VLMA prior to removal.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-II classification patients
- •Patients aged 18-65 years undergoing elective septoplasty
排除标准
- •ASA III-IV classification patients
- •Patients with anticipated difficult airway
- •Patients under 18 years of age
- •History of gastroesophageal reflux disease (GERD) or hiatal hernia
- •Body mass index (BMI) >30
- •Pregnant patients
结局指标
主要结局
Glottis/Trachea and Distal Trachea Blood Contamination Scores
时间窗: Evaluated once at the conclusion of surgery, immediately prior to device removal (approximately 60-120 minutes after anesthesia induction).
The presence of blood contamination will be evaluated separately at two distinct airway sites: Distal trachea: Both SaCoVLM and ETT groups will undergo fiberoptic bronchoscopic evaluation for blood contamination in the distal trachea immediately before removal of the airway device at the end of surgery. Glottis/tracheal inlet: This area will be visually assessed only in the SaCoVLM group using the integrated camera of the video laryngeal mask immediately prior to device removal at the end of surgery. A standardized 4-point scale will be used for both assessments: 1. = No blood contamination 2. = Mild amount of blood contamination (trace amounts) 3. = Moderate amount of blood contamination 4. = Severe amount of blood contamination
次要结局
- Heart Rate (HR)(From preoperative baseline until arrival to the recovery unit (approximately 120 minutes).)
- Airway Insertion Time(Immediately after induction of anesthesia)
- Postoperative Laryngospasm and Bronchospasm(Within 24 hours post-extubation)
- Postoperative Sore Throat (POST Score)(Up to 48 hours postoperatively.)
- Arterial Blood Pressure (Systolic, Diastolic, and Mean)(From preoperative baseline until arrival to the recovery unit (approximately 120 minutes).)
- Total Remifentanil Consumption(Intraoperative)
- Intraoperative Airway Complications(From induction of anesthesia to extubation (intraoperative period))
- Postoperative Dysphagia (Swallowing Difficulty)(Up to 48 hours postoperatively.)
- First-Attempt Success Rate of Airway Device Insertion(Immediately after induction of anesthesia.)
- Postoperative Nausea and Vomiting (PONV)(Up to 48 hours postoperatively.)
- Airway Pressure Parameters (Peak and Mean Airway Pressure)(From 1 minute to 30 minutes after airway device placement.)
- Anesthesia Duration(Intraoperative period (approximately 60-120 minutes))
- Surgical Duration(Intraoperative period (approximately 30-120 minutes))