Evaluation of the Impact of Training Healthcare Teams (Quality Improvement Project) in the Combined Use of AoA Carestation Software and Digital Intraoperative Monitoring Tools (State Entropy, Surgical Pleth Index and Train-of-Four) During General Anesthesia for Intermediate- or Major-risk Surgery on Patient Morbidity and Mortality at 28 Days
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,028
- 试验地点
- 1
- 主要终点
- Occurence of a stroke after surgery in the experimental group
研究概览
简要总结
Tools such as surgical plethysmographic index, state entropy, train-of-four monitors exist to optimize the conduct of general anesthesia in intermediate and major risk surgery as defined by the 2022 European Society of Cardiology Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery. Although these monitors are available on anesthesia machines they are still under-used by teams due to lack of training, practice and a real understanding of their usefulness (operation, expected benefits). When used in conjunction with General Electric's AoA Carestation Insight software, these tools could have a real impact on morbidity and mortality at 28 days post-op. The aim of this prospective monocentric interventional "before/after" study is to assess the impact of training and encouraging teams to use these tools.
详细描述
Recently, complex monitoring tools (nociception by surgical plethysmographic index monitoring, curare by train-of four monitoring, depth of anesthesia by state entropy monitoring) have been developed to optimize the conduct of general anesthesia in intermediate and major risk surgery (surgery defined by the 2022 European Society of Cardiology Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery). In practice, these monitors optimize nociception and the depth of anesthesia, "neither too strong nor too light". These monitors are currently available on our anesthesia machines and can be used routinely. However, these monitors are under-used by teams due to lack of training, practice and real understanding of their usefulness (operation, expected benefits).
Excess nociception and depth of anesthesia are correlated with more postoperative complications, but no studies have ever shown that the combined use of these monitors (surgical plethysmographic index, state entropy, train-of-four) could significantly reduce postoperative morbidity and mortality in patients by optimizing the management of general anesthesia. Software (AoA Carestation insight, General Electric) connected to these monitors can :
- automatically query the use of intraoperative monitors;
- perform usage audits to monitor teams' adherence to their practices;
- coach teams by encouraging them to perform anesthesia while maintaining surgical plethysmographic index (SPI), state entropy (SE) and train-of-four (TOF) values within the thresholds considered in the literature as being optimal for anesthesia (formalized expert recommendations from the SFAR (Société Francaise d'Anesthésie et de Réanimation).
In a prospective monocentric interventional "before/after" study, the aim is to assess the impact of training and encouraging teams to use the AoA Carestation Insight software in conjunction with SPI, SE and TOF monitoring, on morbidity and mortality at 28 days post-op.
The hypothesis is that training and encouraging teams ("quality improvement project") to use these intraoperative monitoring tools (SPI, TOF, SE) during general anesthesia for intermediate- or major-risk surgery could significantly reduce 28-day morbidity and mortality (composite criterion).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an ASA score 2-
- •Patients due to be operated on under general anesthesia for any intermediate- or major-risk non-cardiac procedure lasting > 60 min.
- •Patients affiliated to, or benefiting from, a health insurance plan.
排除标准
- •Patients who have indicated their refusal to participate in the study.
- •Patients scheduled for minor surgery.
- •Patients with an ASA score 1 or
- •Patients due for outpatient surgery.
- •Patients due for surgery under local or locoregional anesthesia.
- •Impossibility of 28-day follow-up.
- •Patients participating in interventional research involving human subjects.
- •Patients in an exclusion period determined by another study.
- •Patients under court protection, guardianship or curatorship.
- •Patients for whom it is impossible to provide clear information.
- •Pregnant, parturient or breast-feeding patients.
研究组 & 干预措施
Control group
638 patients receiving the usual, standard management for anesthesia when undergoing surgery lasting > 60 min and involving intermediate or major non-cardiac risk.
Experimental group
638 patients undergoing surgery lasting > 60 min and involving intermediate or major non-cardiac risk who have been managed by staff trained in the use of surgical plethysmographic index (SPI) state entropy (SE) and train-of-four (TOF) intraoperative monitors and AoA software.
干预措施: Training (Other)
结局指标
主要结局
Occurence of a stroke after surgery in the experimental group
时间窗: Day 28
YES/NO
Occurrence of death after surgery in the control group
时间窗: Day 28
YES/NO
Occurence of arterial or venous thrombosis after surgery in the control group
时间窗: Day 28
YES/NO
Occurence of acute myocardial infarction after surgery in the control group
时间窗: Day 28
YES/NO
Occurence of acute myocardial infarction after surgery in the experimental group
时间窗: Day 28
YES/NO
Occurrence of death after surgery in the experimental group
时间窗: Day 28
YES/NO
Acute kidney injury in the control group: KDIGO criteria and renal replacement therapy. Baseline serum creatinine is obtained from the preoperative blood sample;
时间窗: Day 28
YES/NO
Unplanned admission or readmission to the intensive care unit: experimental group
时间窗: Day 28
YES/NO
Severe acute hypotension (defined as mean arterial pressure < 50 mmHg) in the experimental group
时间窗: Day 28
YES/NO
Cardiac arrhythmia (de novo atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation) in the experimental group
时间窗: Day 28
YES/NO
Postoperative episodes of sepsis and infections (according to the 2001 international definitions of sepsis) in the control group
时间窗: Day 28
YES/NO
Surgical complications in the control group: need for re-operation for any reason and radiological intervention for abscess drainage
时间窗: Day 28
YES/NO
Surgical complications in the experimental group: need for re-operation for any reason and radiological intervention for abscess drainage
时间窗: Day 28
YES/NO
Occurence of arterial or venous thrombosis after surgery in the experimental group
时间窗: Day 28
YES/NO
Postoperative cardiogenic shock (requiring diuretic, epinephrine or dobutamine infusion) in the control group
时间窗: Day 28
YES/NO
Unplanned admission or readmission to the intensive care unit: control group
时间窗: Day 28
YES/NO
Occurence of a stroke after surgery in the control group
时间窗: Day 28
YES/NO
Postoperative cardiogenic shock (requiring diuretic, epinephrine or dobutamine infusion) in the experimental group
时间窗: Day 28
YES/NO
Cardiac arrhythmia (de novo atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation) in the control group
时间窗: Day 28
YES/NO
Acute kidney injury in the experimental group: KDIGO criteria and renal replacement therapy. Baseline serum creatinine is obtained from the preoperative blood sample;
时间窗: Day 28
YES/NO
Severe acute hypotension (defined as mean arterial pressure < 50 mmHg) in the control group
时间窗: Day 28
YES/NO
Post-operative respiratory complications: defined as the need for intubation and/or non-invasive ventilation in the event of respiratory failure in the control group
时间窗: Day 28
YES/NO
次要结局
- Length of time in compliance with mean arterial pressure (MAP < 60 mm Hg) : Experimental group(Day 28)
- Number of episodes of nausea/vomiting up to 12 hours after surgery: Experimental group(12 hours post-surgery)
- Length of stay (hours) in the post-procedure care department : Experimental group(Day 28)
- Length of time in compliance with mean arterial pressure (MAP < 60 mm Hg) : Control group(Day 28)
- Length of hospital stay : Control group(Day 28)
- Length of hospital stay : Experimental group(Day 28)
- Number of episodes of nausea/vomiting up to 24 hours after surgery: Control group(24 hours post-surgery)
- Number of episodes of nausea/vomiting up to 24 hours after surgery: Experimental group(24 hours post-surgery)
- Post-surgical pain at 18 hours as measured by the Control group(At 18 hours post-surgery)
- Post-surgical pain at 36 hours as measured by the Experimental group(At 36 hours post-surgery)
- Post-surgical pain at 42 hours as measured by the Control group(At 42 hours post-surgery)
- Post-surgical pain at 48 hours as measured by the Experimental group(At 48 hours post-surgery)
- Confusion : Experimental group(Postoperative Day 2)
- Monitor use in the Experimental group(Day 0 immediately after surgery)
- Participation rates: anesthesiologist-resuscitation doctors(Day 28)
- Length of stay (hours) in the post-procedure care department : Control group(Day 28)
- Number of episodes of nausea/vomiting up to 48 hours after surgery: Control group(48 hours post-surgery)
- Confusion : Control group(Postoperative Day 2)
- State entropy: time within the defined thresholds: Control group(Day 0 immediately after surgery)
- Compliance with intraoperative therapeutic targets in the Experimental group(Day 0 after surgery)
- Number of episodes of nausea/vomiting up to 12 hours after surgery: Control group(12 hours post-surgery)
- Post-surgical pain at 24 hours as measured by the Control group(At 24 hours post-surgery)
- Post-surgical pain at 30 hours as measured by the Control group(At 30 hours post-surgery)
- Post-surgical pain at 42 hours as measured by the Experimental group(At 42 hours post-surgery)
- Post-surgical pain at 48 hours as measured by the Control group(At 48 hours post-surgery)
- Surgical plethysmographic index : Time within the defined thresholds: Experimental group(Day 0 immediately after surgery)
- State entropy: Time within the defined thresholds: Experimental group(Day 0 immediately after surgery)
- Monitor use in the Control group(Day 0 immediately after surgery)
- Compliance with intraoperative therapeutic targets in the Control group(Day 0 after surgery)
- Participation rates: state registered anesthetic nurses(Day 28)
- Overall satisfaction rate(Day 28)
- Number of episodes of nausea/vomiting up to 48 hours after surgery: Experimental group(48 hours post-surgery)
- Post-surgical pain at 6 hours as measured by the Control group(At 6 hours post-surgery)
- Post-surgical pain at 6 hours as measured by the Experimental group(At 6 hours post-surgery)
- Post-surgical pain at 18 hours as measured by the Experimental group(At 18 hours post-surgery)
- Post-surgical pain at 24 hours as measured by the Experimental group(At 24 hours post-surgery)
- Post-surgical pain at 30 hours as measured by the Experimental group(At 30 hours post-surgery)
- Post-surgical pain at 36 hours as measured by the Control group(At 36 hours post-surgery)
- Post-surgical pain at 12 hours as measured by the Control group(At 12 hours post-surgery)
- Post-surgical pain at 12 hours as measured by the Experimental group(At 12 hours post-surgery)
- Surgical plethysmographic index : time within the defined thresholds: Control group(Day 0 immediately after surgery)
- Train-of-four: Time within the defined thresholds: Control group(Day 0 immediately after surgery)
- Train-of-four: Time within the defined thresholds: Experimental group(Day 0 immediately after surgery)
- Mean arterial pressure: Time within the defined thresholds: Control group(Day 0 immediately after surgery)
- Mean arterial pressure: Time within the defined thresholds: Experimental group(Day 0 immediately after surgery)
- Participation rates: interns(Day 28)
- Overall participation rates: state registered anesthetic nurses, anesthesiologist-resuscitation doctors and interns(Day 28)
- Confusion : Control group(Postoperative Day 1)
- Confusion : Experimental group(Postoperative Day 1)