Comparative Study of the Tightness of the Laryngeal Tube Under Mechanical Ventilation Before and After Reduction of Cuff Pressure on 60cmH₂O, 50cmH₂O, 40cmH₂O or 30cmH₂O
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparison of Leakage between the different Cuff Pressure
研究概览
简要总结
Optimization the cuff pressure of the laryngeal tube (LT) in relation of the mechanical ventilation, and the reduction of potential leakage mucosal trauma. Comparison of the tightness of LT between the filling volume specified by the manufacturer (connectors are color coded syringe and blocker), 60cmH₂O, 50cmH₂O, 40cmH₂Ound 30cmH₂O. The measurement of the leakage occurs in ml / kg body weight.
详细描述
The ventilation of both cuffs of the laryngeal tube by using the color coding of syringe and connector is a simple, fast and easy way to stabilize the tube and secure seal against the surrounding tissue.
The user of this method has only knowledge of the volume (ml), with which the cuff is vented, but not over the cuff pressure (cmH₂O) itself.
Permanently high pressures can cause to a lesions to necrosis in the adjacent tissue, on the other hand, the material of the bulging cuff fits less well the anatomy of the patient, leading to leaks in the breathing circuit.
Studies of pediatric anesthesia show that on 40cmH₂O reduces the volume of the leak in the laryngeal mask airway by reducing the cuff pressure and the ventilation is improved in sequence.
In the proposed study, the volume of leakage at the fill volume specified by the manufacturer (color coding), 60cmH₂O, 50cmH₂O, 40cmH₂O and 30cmH₂O to be captured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 Years
- •No concurrent participation in another study
- •capacity to consent
- •Present written informed consent of the research participant
- •Elective surgery under general anesthesia
- •Height> 150cm
排除标准
- •Age <18 years
- •Existing pregnancy
- •Lack of consent
- •inability to consent
- •emergency patients
- •Emergency situations in the context of a Difficult Airway Management
- •ASA classification> 3
- •situations where the possibility of accumulated gastric contents
- •Indications for intubation with endotracheal tube
- •Height <150cm
- •Participation in another study
研究组 & 干预措施
Reduce Cuff Pressure
Cuff Pressure difference between inspiration and expiration is measured.
干预措施: Reduce Cuff pressure (Device)
结局指标
主要结局
Comparison of Leakage between the different Cuff Pressure
时间窗: < 5 Minutes
We want to measure the tightness of the reduced Cuff Pressure
次要结局
未报告次要终点
研究者
Marc Kriege
Marc Kriege,MD, Rüdiger Noppens, MD
Johannes Gutenberg University Mainz