Redesigned Process in the Operating Room
Redesigned Process in the Operating Room: Monitoring and Evaluating Success of Reducing Non Operative Time
研究概览
地位
详细说明
The study aims to examine whether operating room efficiency will be improved by decreasing non operative time while ensuring patient safety.
Patients will be randomized into one of two groups:
In group A (new process): patients will be inducted in the induction room. At the end of surgery and after placement of the surgical dressing, the registered nurse will call in the house keeper to start cleaning of the OR (parallel processing) before the patient exits the room. The patient will be reversed with sugammadex 4mg/kg IV, and then extubated before being moved out of the OR. In group B (the current practice at AUBMC), patients will be treated as follows: patients will be induced in the operating room and at the end of surgery will be reversed with neostigmine 50µg/kg and glycopyrrolate 10µg/kg. Once extubated and rolled out of the room, the house keeper team will start cleaning the operating room. Induction time (IT), emergence time (ET), and turn over time (TOT) will be recorded for both groups.
We expect to show that OR efficiency will be improved by significantly decreasing non operative time while ensuring patient safety.
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
-
-
-
Beirut、黎巴嫩
- American University of Beirut Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients, above 18 years of age, undergoing general surgery for surgeon X under general anesthesia
- Patients undergoing only the following general surgeries: laparoscopic hernia, laparoscopic appendectomy, laparoscopic cholecystectomy, and laparoscopic gastric/band sleeve surgeries
- American Society of Anesthesiologist Physical Status (ASA) I or II
- Research participant willing to sign informed written consent.
Exclusion Criteria:
- Patients under 18 years of age
- Patients undergoing general surgery for surgeon X under regional or spinal anesthesia
- Patients undergoing surgeries other than the following: laparoscopic hernia, laparoscopic appendectomy, laparoscopic cholecystectomy, and laparoscopic gastric/band sleeve surgeries
- American Society of Anesthesiologist Physical Status (ASA) III, IV, V, and VI
- Emergency and lifesaving Cases
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
- Inability to bring the next patient to the induction room for uncontrollable reasons such as failure of equipment, late arrival to the hospital, or late financial or medical clearance.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Standard process
The control group is placebo group and this is our standard practice.
Patients will be induced in the operating room and at the end of surgery will be reversed with neostigmine 50µg/kg and glycopyrrolate 10µg/kg.
Once extubated and rolled out of the room, the house keeper team will start cleaning the operating room
|
standard process
|
|
有源比较器：Redesigned process
Patients will be inducted in the induction room.
At the end of surgery and after placement of the surgical dressing, the registered nurse will call in the house keeper to start cleaning of the OR (parallel processing) before the patient exits the room.
The patient will be reversed with sugammadex 4mg/kg IV
|
The patients will be inducted in the induction room
The registered nurse will call in the house keeper to start cleaning of the OR (parallel processing) before the patient exits the room
The patient will be reversed with sugammadex 4mg/kg IV, and then extubated before being moved out of the OR
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Non-operative time
大体时间：within 24 hours of surgery
|
For Group A, non-operative time is defined as induction, emergence and turnover time For Group B, non-operative time is defined as turnover time
|
within 24 hours of surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Satisfaction of the operation room staff and surgeons with the redesigned process
大体时间：within 24-48 hours after surgery
|
semi-structured individual interviews
|
within 24-48 hours after surgery
|
|
Patient satisfaction
大体时间：within 24-48 hours aftery surgery
|
Patient satisfaction survey
|
within 24-48 hours aftery surgery
|
|
Complication rate
大体时间：wihtin 24 hours of srugery
|
wihtin 24 hours of srugery
|
合作者和调查者
调查人员
- 首席研究员：Roland Kaddoum, MD、American University of Beirut Medical Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.