BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Percentage of successful reversal of reduction in NIRS, according to the hemodynamic optimization protocol.
研究概览
简要总结
The aim of the study is to further understand whether the use of non-invasive monitoring NIRS (Near Infrared Spectroscopy) is useful in reducing postoperative complications in high-risk patients undergoing elective surgery.
详细描述
Background:
Perioperative complications lead to impaired quality of life as well as prolonged disability. In high risk patients, early hemodynamic optimization with the goal of achieving and maintaining tissue oxygenation in the perioperative period has resulted in an improvement of outcomes and a reduction in surgery-related complications. Maintenance of adequate oxygen delivery to tissue, is one of the fundamental aspects of anesthesia. Regional Oxygen Saturation of the brain tissue (rSO2) as measured by near-infrared spectroscopy (NIRS) is a promising tool in vascular surgery and cardiac surgery for the monitoring of global cerebral perfusion.
Objectives:
This study has the purpose to assess whether an rSO2-based hemodynamic optimization algorithm is able to reduce overall perioperative complications in high risk patients.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •hypertensive patients with American Society of Anesthesiologists (ASA) score≥ 2 with either Age ≥ 65 years or frailty score ≥5
- •presence of an arterial catheter during anesthesia
- •planned high-risk surgery (abdominal, vascular, urologic, thoracic one-lung ventilation (OLV) procedures), longer than 60 minutes, in general anesthesia
- •ability to give informed consent according to International Conference on Harmonization ICH/ Good Clinical Practice (GCP), and national/local regulations
排除标准
- •Unable to consent to study inclusion
- •Language barrier
- •Severe neurological or psychiatric disease
- •End-stage dementia
- •Total Intravenous anesthesia
- •No use of hypertensive medication at home.
结局指标
主要结局
Percentage of successful reversal of reduction in NIRS, according to the hemodynamic optimization protocol.
时间窗: intraoperative
The overall incidence of perioperative complications (including postoperative cognitive dysfunction and delirium).
时间窗: 30 day after randomization
次要结局
- Percentage of time with NIRS within safety limits (<10% reduction)(intraoperative)
- NIRS variations over time, and according to interventions(intraoperative)
- Bispectral index (BIS) over time(intraoperative)
- sevorane concentration over time(intraoperative)
- Evaluate fluid administration(intraoperative)
- Mean arterial pressure (MAP) over time(intraoperative)
- Use of vasopressors and fluids to maintain MAP(intraoperative)