The Clinical Efficacy of the Video Laryngeal Mask (SaCoVLM™) in Geriatric Patients: A Comparison With a Conventional Supraglottic Airway Device (Ambu®Auragain™)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Success of SAD insertion on first attempt.
研究概览
简要总结
This study aims to investigate whether the use of a video LMA device (SacoVLM™) will facilitate successful supraglottic airway device (SAD) insertion compared to the use of a conventional 2nd generation SAD (Ambu®Auragain™) in elderly patients. This study is a randomized trail with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 95 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 65 years of age or older, ASA class I~III, scheduled for elective surgery under general anesthesia under 2 hours, and eligible for SAD use for airway maintenance.
排除标准
- •Refusal to participate, patients unable to read consent form, anticipated difficulty in face mask ventilation or airway management based on past history or anatomical structure, upper respiratory tract infection, airway-related diseases such as asthma or pneumonia, risk of gastroesophageal reflux
结局指标
主要结局
Success of SAD insertion on first attempt.
时间窗: Within the intraoperative period
The success of SAD insertion is defined as when the a normal square-shaped capnography waveform is detected upon manual ventilation and symmetric movements of the patient's chest wall are observed.
次要结局
未报告次要终点