Identification of Risk Factors Causing Difficulty in Laryngeal Mask Insertion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- Success in the first attempt
研究概览
简要总结
Even if the laryngeal mask (LM) is considered a very safe device with a low incidence of complications there may be situations where it is difficult to insert.
Therefore it seems appropriate to carry out a prospective observational study that will identify the risk factors relating to the positioning of LM for the purpose of identification and prediction of them.
From reading the literature and from the opinion of the experts with extensive practice in airway management (part of the Working Group "Management of Airway" of the Italian Society of Anaesthesia, Analgesia, Resuscitation and Intensive Care) some possible causes of difficulty in the insertion of laryngeal mask have been identified; these possible causes were listed in a report that will be distributed to the centers enrolled in the conduction of the study.
1,864 patients will be enrolled in 8 Italian research centers to calculate the relative risk of each of the factors analyzed in order to identify those that, in view of the LM positioning, must be modified to reduce the risk of failure and, secondly, to identify the risk factors whose presence may contraindicate the use of the device and indicate the use of alternative methods for airway management.
详细描述
Backgrounds Since its introduction into clinical practice in 1983, the laryngeal mask (LM) has found a role in the daily practice of anesthesiologists, including its use as a primary device in the airway management in both elective and emergency and as an emergency approach to the management of difficult airways.
Moreover, the insertion of the LM has become a common technique in the management of the airway, in particular outpatient surgery, where it is associated with a shorter recovery time, faster discharge and thus with a reduction of costs.
Even if the LM is considered a device very safe with a low incidence of complications, there may be situations where it is difficult to insert.
Aim of the study Some studies have concerned the causes that determine the difficulty in the insertion of an LM. They are retrospective studies and/or focused on the analysis of a single type of device.
Therefore, it seems appropriate to carry out a prospective observational study that will identify and weight the risk factors relating to the positioning of LM for the purpose of identification and prediction of them.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •ASA classification I-II
- •Age between 18 and 65 years
- •Airway management with laryngeal mask
- •Signed informed consent to the study in the medical record
排除标准
- •Diseases of the upper airways
- •Risk of inhalation of gastric contents (previous gastric surgery, hiatal hernia, gastroesophageal reflux, peptic ulcer, stomach full, pregnancy)
- •Large obese (BMI> 40)
- •Sore throat, voice alteration
- •A history of difficult intubation
- •Intervention lasting more than 4 hours
结局指标
主要结局
Success in the first attempt
时间窗: Immediately after the attempt of insertion
number
次要结局
- Ventilation difficulties(Immediately after the attempt of insertion)
- Need for 2 or more attempts(Immediately after the attempt of insertion)
- Movement or swallowing after placement(Immediately after the attempt of insertion)
- Substitution with another LM of different size(Immediately after the attempt of insertion)
- Change in strategy (intubation, awakening)(Immediately after the attempt of insertion)
研究者
Alessandro Di Filippo
Dr
Azienda Ospedaliero-Universitaria Careggi