Comparison of SafeLM™ Video Laryngeal Mask and I-gel® for Ventilation Safety After Transition to Beach Chair Position in Patients Undergoing Shoulder Surgery: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure (OLP) at two predefined time points: immediately after airway device placement in the supine position and 5 minutes after transition to the beach chair position
研究概览
简要总结
This study aims to compare the performance of SafeLM™ video laryngeal mask airway and i-gel® supraglottic airway device in patients undergoing shoulder surgery in the beach chair position under general anesthesia. The primary objective is to evaluate oropharyngeal leak pressure (OLP) within the first 10 minutes after transition to the beach chair position. Secondary objectives include assessment of ventilation safety, need for airway interventions, and postoperative airway-related complications. This prospective randomized study will provide data on the effectiveness and safety of a video-guided supraglottic airway device compared to a conventional device in a clinically challenging position.
详细描述
Shoulder surgery is frequently performed in the beach chair position (BCP), which may alter upper airway anatomy and increase the risk of airway-related complications. Changes in head and neck alignment, limited access to the airway due to surgical draping, and fluid extravasation during arthroscopy may negatively affect ventilation.
Supraglottic airway devices (SADs) are widely used in general anesthesia due to their ease of insertion and reduced invasiveness compared to endotracheal intubation. The i-gel® is a commonly used second-generation SAD with a non-inflatable cuff, while SafeLM™ is a video-guided laryngeal mask airway that allows real-time visualization of the glottic structures.
This prospective, randomized controlled study aims to compare SafeLM™ and i-gel® in patients undergoing shoulder surgery in the beach chair position. Patients aged 18-80 years with ASA physical status I-III will be randomly assigned to either the SafeLM™ or i-gel® group.
All patients will receive standardized anesthesia management, including induction with propofol and fentanyl and maintenance with sevoflurane. No neuromuscular blocking agents will be used. Following successful placement of the airway device, correct positioning will be confirmed by clinical and capnographic parameters.
The primary outcome of the study is the comparison of oropharyngeal leak pressure (OLP) within the first 10 minutes after transition to the beach chair position. OLP will be measured using a standardized technique with the adjustable pressure-limiting valve set to a maximum of 40 cmH2O.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Scheduled for elective shoulder surgery
- •Body mass index (BMI) between 18-40 kg/m^2
- •Adequate preoperative fasting (approximately 8 hours)
- •Ability and willingness to provide written informed consent
排除标准
- •Age <18 or >80 years
- •Refusal to participate
- •ASA physical status >= IV
- •BMI >40 kg/m^2
- •Failure of supraglottic airway device placement after three attempts
- •Revision surgery
- •Multiple trauma
- •Maxillofacial fracture
- •Active malignancy receiving radiotherapy or chemotherapy
- •Active infection or ongoing antibiotic therapy (except prophylaxis)
- •Chronic steroid or immunosuppressive therapy
- •Full stomach
- •Gastroesophageal reflux disease
- •History of gastric surgery
- •Gastroparesis
- •Known egg allergy
研究组 & 干预措施
SafeLM Group
Participants randomized to this arm will receive airway management using the SafeLM™ video laryngeal mask airway during general anesthesia for shoulder surgery in the beach chair position.
干预措施: SafeLM™ video laryngeal mask airway (Device)
i-gel Group
Participants randomized to this arm will receive airway management using the i-gel® supraglottic airway device during general anesthesia for shoulder surgery in the beach chair position.
干预措施: i-gel® supraglottic airway device (Device)
结局指标
主要结局
Oropharyngeal leak pressure (OLP) at two predefined time points: immediately after airway device placement in the supine position and 5 minutes after transition to the beach chair position
时间窗: Immediately after airway device placement in the supine position and 5 minutes after transition to the beach chair position during surgery
Comparison of oropharyngeal leak pressure (OLP) values measured immediately after insertion of the supraglottic airway device in the supine position and 5 minutes after transition to the beach chair position, as an indicator of airway sealing performance and ventilation safety.
次要结局
- First-attempt success rate of supraglottic airway device placement(Immediately after airway device placement during surgery)
- Number of attempts required for supraglottic airway device placement(Immediately after airway device placement during surgery)
研究者
semih başkan
Principal Investigator
Ankara City Hospital Bilkent