ERAS Implementation in Coronary Artery Bypass Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ERAS bundle compliance in the first 72 hours post-op
研究概览
简要总结
It has been assumed that some elements of the ERAS protocol may contribute to the reduction of complications and improve the satisfaction of patients undergoing coronary artery bypass surgery.
Elements of the ERAS strategy will be tested in this study. The elements that prove to be feasible and have a positive effect on the treatment process will be introduced into everyday clinical practice.
In the next stage of the research, we are planning to investigate whether the introduction of the ERAS strategy has had a long-term positive effect on the quality of life after treatment (a survey 1 month and 6 months after leaving the hospital).
详细描述
Evaluation of the impact of implemented elements of the ERAS strategy on the results of surgical treatment of coronary artery disease in the aspect of:
- preoperative preparation (comprehensive information, premedication, hydration),
- haemodynamic stability (discontinuation of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers immediately before surgery), optimal pre- and intraoperative fluid therapy,
- occurrence of respiratory complications (assessment of the duration of mechanical ventilation and passive oxygen therapy),
- demand for painkillers in the postoperative period, after introducing the preemptive strategy,
- incidence of postoperative delirium,
- time to recovery of the normal bowel function (nausea, vomiting),
- possibility of early mobilisation on the first day after surgery,
- patient's satisfaction with treatment assessed on the basis of a survey carried out on the day before leaving the hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CABG/OPCAB (Coronary Artery Bypass Surgery/Off Pump Coronary Bypass Surgery).
- •Left ventricular ejection fraction above 35% (EF ≥ 35%).
- •The operation was performed in a planned mode.
排除标准
- •Haematological diseases and the associated increased risk of bleeding in the early postoperative period. Patients taking anticoagulants until the day of surgery with the exception of aspirin.
- •Neurological disorders, stroke with persistent symptoms, dementia.
- •Chronic lung disease with hypoxia and the need for regular medication.
- •Inability to move independently, disability preventing efficient rehabilitation, prolonged use of painkillers.
- •Emergency surgery, reoperation.
- •Return to the operating room regardless of the reason (resternotomy).
- •Perioperative infarction with circulatory destabilization.
研究组 & 干预措施
Study group
Implemented ERAS (Early Recovery After Surgery) elements
干预措施: Premedication visit (Behavioral)
Study group
Implemented ERAS (Early Recovery After Surgery) elements
干预措施: Preoperative period (Drug)
Study group
Implemented ERAS (Early Recovery After Surgery) elements
干预措施: Postoperative period (Other)
Study group
Implemented ERAS (Early Recovery After Surgery) elements
干预措施: Intraoperative period (Drug)
结局指标
主要结局
ERAS bundle compliance in the first 72 hours post-op
时间窗: 72 hours post operation
Number of interventions for the ERAS protocol that are delivered to patient (numeric data e.g. 5 out of 10)
Shorter Length Of Hospitalization (LOH)
时间窗: up to 4 weeks after operation
Total amount of days spent in hospital
次要结局
- Time to drink(0-72 hours)
- Time to eating(0-72 hours)
- Time to bowel movement(in hours after extubation, up to 1 week)
- Incidence of postoperative delirium(in hours after extubation, up to 72 hours)
- Preoperative anxiety(on admission to the operating unit)
- Time to extubation(0 -72 hours)
- Assessment of postoperative pain(0-24 hours)
- Incidence of postoperative nausea and vomiting(At moment 0, 3, 6, 12 and 24 hours after extubation)
- Postoperative complications(up to 2 weeks after surgery)
- Time to mobilisation(0-72 hours)
研究者
Ewa Kucewicz-Czech
Clinical Professor, Head of Unit
Silesian University of Medicine