Centralised Anesthesic Monitoring in the Surgery of the Ocular Anterior Segment: Non Inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Anesthetic potential impact on surgery conditions
研究概览
简要总结
In France, cataract surgery is the most frequent surgical procedure, performed with local anesthesia and most often very light techniques using eye-drops. Technical improvements of surgical and anesthesic procedures have led many countries to implement alternative surveillance procedures. In France, it is mandatory that the persons in charge of anesthetic surveillance (doctors or nurses) should be qualified in anesthesia.
In this study, the investigators aim to assess the feasibility and safety of a centralised monitoring station outside of the operating rooms, as an alternative to the presence of 1 anesthetic nurse in each operating room.
详细描述
In their hospital, the investigators will study the following alternatives for the anesthetic surveillance of the 3 operating rooms where surgery of the ocular anterior segment is performed: 1) the usual procedure, with the presence of 3 anesthetic nurses (1 in each operating room) and 2) a new organization with an anesthetic nurse checking a centralised monitoring station and a back-up anesthetic nurse ready to intervene inside the 3 operating rooms whenever needed.
The 2 procedures will be successively implemented during 3 to 4 sequences, until the number of surgical procedures statistically required have been studied.
The investigators aim to demonstrate that the centralised monitored surveillance does not put the patients at risk more often than the current surveillance procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •adult patient scheduled for ocular anterior segment surgery (cataract, glaucoma, pterygium) with local or topic anesthesia
排除标准
- •patient refusing to participate in the study or without health insurance
结局指标
主要结局
Anesthetic potential impact on surgery conditions
时间窗: during surgical procedure
Incidence rate of at least 1 of the following events, during surgery: * blood pressure \> 200 mmHg on 2 consecutive measures (automatic measure every 3 minutes) * cardiac frequency \< 45/min for at least 1 mn * SaO2 \<85% for at least 1 mn * poor operating conditions (rated ≤ 7 by the surgeon, on a numeric scale from 0 to 10=excellent conditions). Assessment at the exit of operating room.
次要结局
- patient pre-surgical stress(baseline)
- interventions of the back-up anesthetic nurse(during surgical procedure)
- incidence rate of each of the events included in the primary outcome(during surgical procedure)
- working conditions(at the end of a working day)
- pain during surgical procedure(within 10 minutes after surgery)
- patient agitation(within 10 minutes after surgery)
- patient satisfaction(within 10 minutes after surgery)
- operating conditions(within 10 minutes after surgery)