A Multicenter, Randomized Controlled Study Comparing the Effectiveness of the New Generation GMA Laryngeal Mask and Conventional Laryngeal Mask in Airway Management During General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,384
- 试验地点
- 1
- 主要终点
- Success rate of anatomical alignment of laryngeal mask
研究概览
简要总结
This study aims to compare the new-generation GMA laryngeal mask airway (LMA) with the traditional inflatable LMA in patients undergoing elective surgery under general anesthesia. The primary objectives are to evaluate the safety, effectiveness, stability, ease of use, and patient comfort of the GMA LMA, providing practical guidance for clinical airway management. Additionally, this research will analyze the anatomical positioning and sealing mechanism of the LMA to identify factors influencing proper alignment and airway sealing. The findings may contribute to future improvements in LMA design, enhancing patient safety and procedural success.
This study is designed for healthcare providers, anesthesiologists, and researchers seeking evidence-based recommendations for LMA selection in clinical practice. Participation involves standard anesthesia procedures with close monitoring to ensure patient safety.
详细描述
Eligible patients meeting the inclusion criteria were enrolled in the study and randomly assigned into two groups using a random number table: the traditional Inflatable Laryngeal Mask Airway Group (Group L) and the GMA Group (Group G). One day before surgery, the research team conducted preliminary screening of patients scheduled for elective surgery, followed by a preoperative visit to explain the study's purpose, anesthesia considerations, and obtain informed consent. Upon entering the operating room, standard monitoring (ECG, blood pressure, pulse oximetry, etc.) was applied. The research team recorded the patient's actual fasting duration, last intake (food/liquid type), and baseline characteristics, including age, sex, height, weight, BMI, comorbidities, ASA classification, surgical type, and preoperative anxiety level. Airway assessment was reconfirmed. Anesthesia induction was performed with intravenous etomidate, vecuronium, and sufentanil. After loss of consciousness and disappearance of the eyelash reflex, manual ventilation was initiated. Following induction, the laryngeal mask was inserted.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Age 18-75 years;
- •ASA physical status I-II;
- •Strict compliance with ASA fasting guidelines;
- •Normal airway anatomy;
- •Voluntary participation with signed informed consent.
排除标准
- •Pre-existing aspiration risk or gastrointestinal disorders;
- •Oropharyngeal/laryngeal abnormalities;
- •Anticipated difficult airway (≥1 of the following):
- •BMI >30 kg/m² Mouth opening <3 cm Mallampati class III-IV Restricted neck mobility
- •Contraindications to LMA use;
- •Communication or cognitive impairments;
- •Other exclusions at investigator's discretion
研究组 & 干预措施
Inflatable LMA Group
Patients in this group will receive airway management using the standard inflatable LMA (Laryngeal Mask Airway) during general anesthesia. The device will be inserted according to manufacturer guidelines, and sealing pressure, insertion success rate, and ventilation efficacy will be recorded.
干预措施: Inflatable Laryngeal Mask Airway (Device)
GMA Group
Patients in this group will receive airway management using the GMA-Tulip LMA, a modified supraglottic airway device. Insertion technique and outcome measurements (e.g., sealing pressure, ventilation parameters) will be recorded.
干预措施: GMA Laryngeal Mask Airway (Device)
结局指标
主要结局
Success rate of anatomical alignment of laryngeal mask
时间窗: During LMA placement (immediately after insertion)
Comparison of anatomical positioning success rates between inflatable LMA and GMA-Tulip LMA, assessed by fiberoptic bronchoscopy (FOB).
次要结局
- Patient Tolerance Score(Within 60 minutes after LMA removal)
- Sealing pressure and positional stability of the GMA-Tulip versus inflatable LMA(Intraoperative period (from LMA insertion until removal at end of surgery))
- First-attempt success rate of LMA(during procedure)
- Time to Successful Placement of LMA(during procedure)
- Hemodynamic response to LMA insertion and removal(Intraoperative period)
- Oxygenation Stability (Intraoperative)(From patient entry into operating room to the time for LMA removal)
- Ventilation Parameters (Intraoperative)(from the start of mechanical ventilation after LMA placement to LMA removal)
- Feasibility of gastric tube insertion through LMA(During LMA placement (after confirmation of correct LMA position).)
- LMA-Related Complications(Day 0)
- Anesthesiologist Satisfaction Survey(Within 30 minutes after surgery completion)
- Surgeon Satisfaction Assessment(Within 30 minutes after surgery completion)
- Patient Satisfaction Survey(Within 24 hours after surgery)
- Ultrasonographic Assessment of Gastric Antrum Cross-Sectional Area (CSA) in Supine Position for Monitoring Gastric Insufflation(Baseline: Within 10 minutes before anesthesia induction; Post-intervention: Within 3 minutes after successful LMA placement; Postoperative: After surgical closure but before LMA removal)
研究者
xiangming fang
Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor
First Affiliated Hospital of Zhejiang University