Software Development for Anesthesiology Guideline Implementation in the Perioperative Course
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- correct approval for operation
研究概览
简要总结
Aim of the project is the development of a software for implementation of anesthesiology guidelines in the preoperative evaluation. The software bases on the 2014 and 2018 guidelines of the European Society of Anesthesiology (ESA) for the pre-operative evaluation of adults undergoing non-cardiac surgery.
Traditional premedication is compared with the new software-guided premedication by using a cross-over design. 200 patients are included in the study, 100 of which are first evaluated the traditional way and then with the software, 100 patients are treated the other way round. Results of the two premedication methods are compared according to the primary endpoint "correct approval for OP" and the secondary endpoints number of missed apparative examinations, number of unnecessary apparative examinations, time required for premedication, length of hospital stay, mortality and postoperative complications.
详细描述
Type of study:
Monocentric, prospective cohort study
Procedure for informing and obtaining consent:
Patients who are prepared for surgery in the anesthetic outpatient department or enrolled in the pre-medication list and who meet all inclusion criteria and no exclusion criteria will be identified before the anesthesia consultation. The patients will be informed about the purpose and the course of the study in oral and written form, after which the written consent of the patient will be given before the study-relevant data and examinations are carried out.
Description of the data sources (medical records, questionnaires, etc.):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >= 18 years
- •ASA 3 or 4
- •elective surgery
- •written informed consent
排除标准
- •emergency surgery
- •patient not being able to give informed consent
- •non-german-speaking patients
研究组 & 干预措施
Software first
Patients that are pre-operatively assessed first software-guided and then traditional
干预措施: Premedication Guide (Device)
Traditional
Patients that are first pre-operatively assessed in the traditional way and then with aid of the software
干预措施: Premedication Guide (Device)
结局指标
主要结局
correct approval for operation
时间窗: 1 day
number of patients that were approved correctly for surgery
次要结局
- length of hospital stay(30 days)
- unnecessary examinations(1 day)
- mortality(30 days)
- missing examinations(1 day)
- postoperative complications(30 days)