Comparison of Airway Control Effectiveness of the SafeLM Video Laryngeal Mask and the LMA Classic in Patients Undergoing General Anesthesia for Fibroadenoma Excision
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 132
- 主要终点
- Oropharyngeal Leak Pressure (OLP)
研究概览
简要总结
This randomized controlled trial compares the airway management performance of the SafeLM video laryngeal mask with the LMA Classic in adult patients undergoing elective fibroadenoma excision under general anesthesia. Participants will be randomly assigned to airway management with either the SafeLM or the LMA Classic. The primary outcome is oropharyngeal leak pressure. Secondary outcomes include insertion performance, ventilation parameters, hemodynamic responses, and airway-related adverse events.
详细描述
The SafeLM is a video-assisted laryngeal mask that allows visualization during placement, whereas the LMA Classic is a conventional supraglottic airway device. This study is designed to compare the clinical performance of these two devices under standardized conditions.
Adult patients scheduled for elective fibroadenoma excision under general anesthesia will be screened for eligibility. Only patients for whom both devices are considered clinically appropriate will be enrolled, thereby avoiding randomization when patient characteristics indicate a preference for a particular airway management technique. Eligible participants will be randomly assigned to airway management with either the SafeLM or the LMA Classic.
After standardized induction of general anesthesia, the assigned laryngeal mask will be inserted according to the study protocol. The primary outcome is oropharyngeal leak pressure after successful placement. Device insertion characteristics, ventilation parameters, hemodynamic responses, and airway-related adverse events will also be evaluated.
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
- Single (Participant)
盲法说明
Participants will be unaware of the assigned laryngeal mask device. The anesthesiologist performing device insertion and intraoperative outcome assessment cannot be masked because of the visible differences between the two devices.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 years or older.
- •Scheduled for elective excision of benign breast fibroadenoma under general anesthesia.
- •Planned airway management with a laryngeal mask airway.
- •American Society of Anesthesiologists (ASA) physical status I-II.
- •Both the SafeLM and LMA Classic are considered clinically appropriate for airway management.
- •Provision of written informed consent.
排除标准
- •Increased risk of pulmonary aspiration, including inadequate preoperative fasting, full stomach, or gastrointestinal obstruction.
- •Known or suspected difficult airway or other airway characteristics for which random allocation between the two study devices is considered clinically inappropriate.
- •Upper airway pathology or anatomical abnormality that may interfere with laryngeal mask placement.
- •Clinical or surgical indication requiring tracheal intubation rather than a laryngeal mask airway.
- •Contraindication or known allergy to medications used in the standardized anesthesia protocol.
- •Inability to provide informed consent.
研究组 & 干预措施
SafeLM Video Laryngeal Mask
Participants randomized to this arm will receive airway management with the SafeLM video laryngeal mask during general anesthesia for elective fibroadenoma excision. The device will be inserted according to the standardized study protocol.
干预措施: SafeLM Video Laryngeal Mask (Device)
LMA Classic
Participants randomized to this arm will receive airway management with the LMA Classic during general anesthesia for elective fibroadenoma excision. The device will be inserted according to the standardized study protocol.
干预措施: LMA Classic (Device)
结局指标
主要结局
Oropharyngeal Leak Pressure (OLP)
时间窗: Immediately after successful laryngeal mask placement, before the start of surgery
Oropharyngeal leak pressure will be measured after successful placement of the assigned laryngeal mask and establishment of effective ventilation. OLP will be recorded in cmH2O as the airway pressure at which an audible oropharyngeal leak is detected during a standardized leak test.
次要结局
- First-attempt insertion success(During initial laryngeal mask insertion)
- Overall insertion success(During laryngeal mask insertion, up to 3 attempts)
- Laryngeal mask insertion time(During laryngeal mask insertion)
- Number of insertion attempts(During laryngeal mask insertion)
- Need for additional airway maneuvers(During laryngeal mask insertion)
- Peak inspiratory pressure(At 5 and 30 minutes after successful laryngeal mask placement)
- End-tidal carbon dioxide(At 5 and 30 minutes after successful laryngeal mask placement)
- Hemodynamic changes(At baseline, immediately after insertion, and 5 and 30 minutes after successful placement)
- Blood staining on the laryngeal mask(Immediately after device removal)
- Postoperative sore throat(At 1 and 24 hours after surgery)
- Postoperative hoarseness(At 1 and 24 hours after surgery)
- Airway-related adverse events(From laryngeal mask insertion through post-anesthesia care unit discharge)