Comparison of Protector Laryngeal Mask With Endotracheal Tube: Evaluation of Respiratory Mechanical Parameters During Controlled Ventilation & Possibility of Pulmonary Aspiration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Difference in PIP cmH20 (Peak inspiratory pressure ) between the two groups of patients.
研究概览
简要总结
The aim of this prospective, randomized, comparative, controlled clinical study is to compare laryngeal mask airway ProtectorTM with the endotracheal tube, regarding to the respiratory mechanical parameters during controlled mechanical ventilation and the prevalence of aspiration. Aspiration will be evaluated by detecting and quantifying pepsin (a marker of gastric aspiration) and α-amylase (a marker of salivary aspiration) in the bronchoalveolar lavage ( mini BAL) of patients ≥18 years old, ASA 1-2, undergoing selective low-risk surgery under general anesthesia in a lithotomy position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged ≥18 years ASA1-2 who are to undergo planned urological surgery of low or intermediate severity, under general anesthesia in the lithotomy position.
排除标准
- •patients < 18 years old.
- •Patients who are going to undergo an emergency/urgent operation/ trauma patients.
- •Maternal population.
- •Patients who are not scheduled to receive general anesthesia, but some other type of anesthesia.
- •Patients in whom LMA placement is contraindicated, such as patients at high risk for reflux and aspiration of gastric contents (eg, history of gastroesophageal reflux, hiatal hernia, pyloric stenosis, gastrointestinal obstruction, morbid obesity).
- •Patients who meet at least one of the four RODS difficulty criteria.
- •Contraindicated patients: administration of neuromuscular blockade, suppression of spontaneous respiration, and those with an indication for awake intubation or surgical airway.
- •Patients who refuse to participate in the study.
结局指标
主要结局
Difference in PIP cmH20 (Peak inspiratory pressure ) between the two groups of patients.
时间窗: Intraoperative
Measured by Ventilator
Assessment of aspiration risk by quantitative measurements of pepsin (ng/ml) and α-amylase (IU/ml) in BAL of patients and differences in its incidence between the two groups.
时间窗: through study completion, an average of 1 year
Measured by ELISA method
次要结局
- Differences in lung mechanics between the two patient groups(Intraoperative)
研究者
Stella Antoniou
MD
University Hospital of Patras