Evaluation of the Effectiveness of an Enhanced Recovery After Surgery Protocol in Patients Undergoing On-pump Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Time before patient extubation
研究概览
简要总结
In 2019, the Enhanced Recovery After Surgery (ERAS) Society published recommendations for perioperative care in cardiac surgery. ERAS recommendations included 22 perioperative interventions that may be part of any cardiac Enhanced Recovery Program (ERP). Since that publication, additional perioperative interventions were reported and may be added to a cardiac ERP. Studies on cardiac ERPs report variable benefits on postoperative recovery including lower pain scores, lower opioid consumption and related side effects, shorter intensive care unit and hospital discharge times. At the "Centre Hospitalier de l'Université de Montréal" (CHUM), although most care takers are aware of ERAS recommendations for cardiac surgery patients, adherence to these recommendations is heterogeneous and a cardiac ERP was never implemented.
详细描述
Primary objective: Estimate the effect of implementation of an ERP (including the use of a checklist and teaching of caretakers) on the time needed for patient extubation after on-pump cardiac surgery.
Secondary objective: Estimate the effect of implementation of a ERP (including the use of a checklist and teaching of caretakers) on the need for reintubation, the need to return to the operating room for hemostasis, on pain scores, opioid consumption and related side effects, on the incidence of postoperative delirium in the intensive care unit, on intensive care unit and hospital discharge times, on postoperative complications (stroke, acute renal failure, postoperative atrial fibrillation), and on in-hospital mortality, 30-day mortality and hospital readmission.
The hypothesis of the study is that implementation of an ERP (including the use of a checklist and teaching of caretakers) in patients undergoing on-pump cardiac surgery improves postoperative recovery through shorter extubation time and a reduction of postoperative complications.
Design of the study: single center, bidirectional (prospective and retrospective) chronological cohort study. The adherence to ERP interventions will be measured.
Prospective data will be collected in eligible patients after implementation of a cardiac ERP and compared retrospectively with eligible patients who had surgery in the year before (but not in the four weeks preceding) implementation of the cardiac ERP. In these patients, prospective data is already collected in a quality of care database in cardiac surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On-pump cardiac surgery
排除标准
- •Left Ventricular Ejection Fraction (LVEF) lower than 50%
- •Glomerular filtration rate lower than 50 mL/min
- •Significant pulmonary hypertension (systolic pulmonary artery pressure higher than 65 mmHg)
- •Presence of Intra-aortic balloon pump therapy before surgery
- •Endocarditis surgery
- •An estimated mortality over 8% based on the EuroSCORE II
- •Patients who already had cardiac surgery in the past.
结局指标
主要结局
Time before patient extubation
时间窗: From the end of the surgery to extubation, up to 1 week
Time elapsed between final wound dressing and removal of the endotracheal tube, before and after implementation of the cardiac ERP.
次要结局
- Incidence of reintubation(Up to 24 hours after extubation)
- Opioid side effects(8, 16, 24 and 48 hours after surgery)
- Acute pain scores using the Numerical Rating Scale (NRS)(8, 16, 24 and 48 hours after surgery)
- Postoperative complications(Up to 7 days after surgery)
- ICU discharge time(At ICU discharge, an average of one day after surgery)
- In-hospital mortality(At hospital discharge, an average of one week after surgery)
- 30-day mortality(Up to 30 days after surgery)
- Opioid consumption(8, 16, 24 and 48 hours after surgery)
- Incidence of delirium in the intensive care unit (ICU) using the ICDSC score(Up to 7 days after surgery or ICU discharge, whichever comes first)
- Hospital discharge(At hospital discharge, an average of one week after surgery)
- Hospital readmission(Up to 30 days after surgery)