A Randomized Controlled Clinical Study on Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Clinical prognosis
研究概览
简要总结
Enhanced recovery after surgery (ERAS) is a strategy of perioperative management aimed to accelerate the rehabilitation of patients through various optimized perioperative managements as well as ongoing adherence to a patient-focused, multidisciplinary, and multimodal approach. Alleviating the injury and stress caused by surgery or disease is the core principle of ERAS, which has been shown to reduce complication rates after surgery, promote patient recovery, decrease hospital length of stay and reduce costs. ERAS has been widely applied in many surgical perioperative fields, and it has achieved remarkable effects. However, there are few applications of ERAS in neurosurgery, especially in clinical trials of neurocritical care patients.
Therefore, the investigators attempt to conduct the study of ERAS in neurosurgical intensive patients using a series of optimized perioperative managements that have been verified to be effective by evidence-based medicine, and to evaluate the safety and effectiveness of ERAS in neurocritical care. The aim of this study is to explore the most suitable ERAS protocols to accelerate the postoperative rehabilitation process of neurocritical care patients, and to provide more evidence-based medicine for the effectiveness and safety of ERAS in neurosurgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Age 18-75 years old
- •Patients with moderate or severe acute traumatic brain injury or cerebrovascular disease requiring neurosurgical intensive care treatment
- •Hospitalization time ≥ 1 week
- •The guardian is able to understand and actively cooperate in completing the project
- •The guardian signs an informed consent form
排除标准
- •Patients undergoing non-surgical treatment
- •Patients diagnosed as brain death within the first 24 hours after admission to NICU
- •Patients undergoing cardiopulmonary resuscitation, maintenance dialysis, end-stage tumors, and disseminated cancer
- •Patients who withdraw treatment during hospitalization or are discharged automatically
- •Patients who underwent unplanned secondary surgery during the research process
- •Individuals who cannot be followed up during the research process
结局指标
主要结局
Clinical prognosis
时间窗: One month, three and six months after injury or attack
Glasgow Outcome Scale score (1 = death; 2 = persistent vegetative state; 3 = severe disability; 4 = moderate disability; 5 = good but not necessarily complete recovery; unfavorable outcome was defined as score of ≤3, and favorable outcome was defined as a score of \>3)
Neurological function assessment
时间窗: One month, three and six months after injury or attack
Modified Rankin scale score (0 = no symptoms; 1 = no significant disability; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = dead; favorable outcome was defined as score of 0-2, and unfavorable outcome was defined as score of 3-6)
次要结局
- Neuroimaging evaluation(One week, two weeks after surgery; one month, three and six months after injury or attack)
研究者
Hao Chen, MD, PhD
Associate Professor, Chief Physician, Graduate Supervisor
Shanghai 6th People's Hospital