An in Vivo CT Imaging Study After Insertion of the LMA Supreme, I-gel, and GMA-Tulip Airway Devices Under General Anesthesia (GLAM-II)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Insertion depth of the three laryngeal masks
研究概览
简要总结
Laryngeal masks are core devices for supraglottic airway management, and the accuracy of their anatomical position directly impacts ventilation safety and the incidence of complications. Despite their wide clinical application, gaps remain in understanding their in vivo anatomical characteristics. This study aims to evaluate the in vivo anatomical features (e.g., insertion depth, anatomical alignment, tissue compression) of three laryngeal masks (LMA Supreme, I-gel, GMA-Tulip) using CT scanning in anesthetized patients undergoing CT interventional therapy, providing anatomical evidence for optimized laryngeal mask selection and complication prevention.
详细描述
After approval by the Ethics Committee of Zhejiang Cancer Hospital (Approval Number: IRB-2025-001 (IIT)), this study will be registered on ClinicalTrials.gov prior to participant enrollment. Written informed consent will be obtained from all participants. The study is planned to be conducted from September 2025 to December 2025.
Eligible participants are 18-75 years old, ASA physical status I-II, BMI <30 kg/m², scheduled for CT interventional therapy, and without contraindications (e.g., head/neck airway anomalies, participation in other clinical studies).
Pre-procedure Preparation: Patients fast and abstain from fluids as per standard protocols, with no premedication. Upon admission to the operating room, standard monitoring (ECG, HR, BP, SpO₂) is initiated, and an intravenous access is established. Pre-anesthesia baseline HR and BP are recorded.
Anesthesia Induction: Pre-oxygenation with 8 L/min oxygen via face mask for 3 minutes. Anesthesia is induced with propofol (3.5 μg/ml) and remifentanil (4 ng/ml). After loss of eyelash reflex, rocuronium (0.9 mg/kg) is administered, and laryngeal mask insertion is performed 2 minutes post-rocuronium injection.
Laryngeal Mask Insertion: Participants are randomly assigned (via computer-generated sequence) to one of three groups: LMA Supreme Group (L Group), I-gel Group (I Group), or GMA-Tulip Group (G Group). Each patient receives one laryngeal mask insertion by an anesthesiologist with ≥5 years of experience, following standardized insertion protocols for each device:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Device Feasibility
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Aged 18-75 years, scheduled for CT interventional therapy;
- •Aged 18-75 years, scheduled for CT interventional therapy;
- •Body Mass Index (BMI) <30 kg/m²;
- •Good communication and cooperation, with voluntary signing of the informed consent form.
排除标准
- •Presence of head/neck or airway anatomical abnormalities (e.g., laryngeal cartilage malformation, Grade III tonsillar hypertrophy, tongue hypertrophy, cervical spine malformation) that may affect laryngeal mask insertion or CT imaging evaluation;
- •Current participation in other clinical studies.
研究组 & 干预措施
GMA-Tulip
Insert GMA-Tulip in this group and observe the outcomes
干预措施: GMA-Tulip (Device)
I-gel
Insert I-gel in this group and observe the outcomes
干预措施: I-gel (Device)
LMA-Supreme
Insert LMA-Supreme in this group and observe the outcomes
干预措施: LMA-Supreme insertion (Device)
结局指标
主要结局
Insertion depth of the three laryngeal masks
时间窗: During CT scanning immediately after laryngeal mask insertion (within 30 minutes of insertion)
Measurement of the distance from the laryngeal mask tip to the glottis and the upper edge of the 5th cervical vertebra (C5), and the relationship between the mask tip and the cricoid cartilage plate (via CT imaging)
次要结局
- Anatomical alignment of the three laryngeal masks(During fiberoptic examination and CT scanning immediately after laryngeal mask insertion)
- Post-extubation complications(24 hours after laryngeal mask extubation)
- Degree of local tissue compression(During CT scanning immediately after laryngeal mask insertion.)
研究者
Wang Jiangling
Principal Investigator
Zhejiang Cancer Hospital