First-Attempt Insertion Success of a Novel Two-Person Lateral Rotation Technique Versus the Standard Brain Technique for Laryngeal Mask Airway Placement: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- First-attempt insertion success rate, defined as successful placement achieving effective ventilation on the first introduction of the LMA into the oral cavity
研究概览
简要总结
The goal of this clinical trial is to learn if two person lateral rotation technique of LMA insertion is more successful than the standard technique in achieving effective ventilation on the first introduction of the LMA .The main questions it aims to answer are:
Does two person lateral rotation technique of LMA insertion lower the number of times needed to inesrt the LMA ?
Researchers will compare two person lateral rotation technique of LMA insertion to standard technique to see if it is more successful
Participants will be subjected to the two way of LMA insertion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Adult patients aged 18-65 years
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Scheduled for elective superficial surgical procedures under general anesthesia (e.g., limb orthopedic surgery, hernioplasty, soft tissue excision)
- •Anticipated surgical duration < 90 minutes
- •Body mass index (BMI) 18.5-30 kg/m²
排除标准
- •- Anticipated difficult airway (Mallampati grade IV, thyromental distance < 6 cm, limited neck extension)
- •History of gastroesophageal reflux disease or increased aspiration risk
- •Full stomach or emergency surgery - Intra-abdominal, laparoscopic, head and neck, or prone-position procedures - Known allergy to anesthetic agents
- •Pregnancy
- •Previous pharyngeal or laryngeal surgery - Inability to provide informed consent
结局指标
主要结局
First-attempt insertion success rate, defined as successful placement achieving effective ventilation on the first introduction of the LMA into the oral cavity
时间窗: 1 minute after LMA insertion
次要结局
- Insertion time(20-90 seconds from picking up the LMA to be inserted in the mouth)
- Number of attempts(2-3 minutes after induction of anesthesia)
- Need for manipulations(1-2 minutes after induction of anesthesia)
- Oropharyngeal leak pressure (OLP)(1-2 minutes after insertion of LMA)
- Complications:(immediate after removal of LMA ,1,2,4,24 hours. post operative)
研究者
Taghreed Elshahat Sakr
lecturer
Benha University