Telemedicine Control Tower for the Operating Room: Navigating Information, Care and Safety - Randomized Pragmatic Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 79,560
- 试验地点
- 1
- 主要终点
- Number of Participants With Postoperative Respiratory Failure
研究概览
简要总结
Medical errors account for thousands of potentially preventable deaths each year. With the annual increase of surgical cases there is a need for research into the potential utility of a telemedicine-based control center for the operating room to assess risk, diagnose negative patient trajectories, implement evidence-based practices, and improve outcomes.
详细描述
This will be a single center, randomized, controlled, phase 3 pragmatic clinical trial. Forty-eight operating rooms will be randomized daily to receive support from the ACT or not. All adults (eighteen years and older) undergoing surgical procedures in these operating rooms will be included and followed until 30-days after their surgery. Clinicians in operating rooms randomized to 'intervention' will receive decision support from clinicians in the ACT. In operating rooms not randomized to receive decision support from the ACT, the current standard of anesthesia care will be delivered. The intention-to-treat principle will be followed for all analyses.
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)
盲法说明
Anesthesia practitioner un-blinded to intervention, subject blinded to intervention, data analyst blinded to intervention, ACT Clinicians un-blinded to intervention
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
- •All patients 18 years or older undergoing surgery at Barnes Jewish Hospital in St. Louis, MO
排除标准
- 未提供
研究组 & 干预措施
Standard of care arm
Operating rooms in the standard of care group will be monitored but, the ACT clinicians will not contact the operating room unless it is clinically necessary for patient safety purposes.
Anesthesia Control Tower monitoring
Clinicians in the Anesthesiology Control Tower will provide extra support for the anesthesiology team in the operating room using AlertWatch and integrating machine-learning forecasting algorithms for adverse outcomes.
干预措施: Anesthesia Control Tower monitoring (Device)
结局指标
主要结局
Number of Participants With Postoperative Respiratory Failure
时间窗: 30 days post-op
Defined as mechanical ventilation for greater than 24 hours after surgery, or unplanned postoperative re-intubation and mechanical ventilation within 30 days of surgery.
Thirty-day Postoperative Mortality
时间窗: 30 days post-op
This will include death of any cause occurring in or out of the hospital, within 30 days of the index surgery.
Number of Participants With Postoperative Delirium
时间窗: 7 days post-op
Defined as an acute change in consciousness or cognition. It has a fluctuating course, and is characterized by inattention, disorganized thinking and altered level of consciousness. The institution has trained the nursing staff on our surgical intensive care units to assess all patients for postoperative delirium using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) instrument.
Number of Participants With Postoperative Acute Kidney Injury
时间窗: 7 days post-op
Diagnosed when any of the following three criteria are met: (i) an increase in serum creatinine by 50% compared with preoperative within 7 days, (ii) any increase in serum creatinine \> 0.3 mg/dL in 48 hours, or (iii) oliguria (urine output \<0.5 mL/kg/hr for 6-12 hours).
次要结局
- Antibiotic Redosing(1 day)
- Mean Arterial Pressure Management(1 day)
- Measured Anesthetic Concentration(1 day)
- Fresh Gas Flow Rates(1 day)
- Temperature Management(1 day)
- Mean Airway Pressure With Mechanical Ventilation(1 day)
- Blood Glucose Management(1 day)