Effect of a Non-Invasive Hypotension Prediction Index on Intraoperative Hypotension and Postoperative Complications in Elder Patients During Arthroscopic Shoulder Surgery in the Beach Chair Position
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- the incidence of cerebral desaturation events
研究概览
简要总结
Intraoperative hypotension (defined as mean arterial pressure <65 mmHg) is a common occurrence during anesthesia and has been associated with increased risk of intraoperative hypoxia and postoperative complications, including stroke and acute kidney injury. Preventing intraoperative hypotension is therefore critical to reducing postoperative morbidity.
The number of patients undergoing arthroscopic shoulder surgery has been increasing. When performed in the beach chair position, gravitational effects reduce venous return, decrease cardiac output, and predispose patients to hypotension. Anesthetic agents further impair autonomic regulation and vascular tone, exacerbating the risk. Because the brain is positioned above the heart, cerebral perfusion pressure may decrease significantly, increasing the risk of intraoperative ischemia and postoperative neurological complications. Active monitoring and prevention of hypotension are thus essential.
The noninvasive Hypotension Prediction Index (HPI) is a novel, non-invasive tool designed to predict impending hypotensive events and guide timely intervention. While it has been evaluated in some small randomized controlled trials, there is currently a lack of RCTs specifically assessing the use of non-invasive HPI-guided management in patients undergoing arthroscopic shoulder surgery in the beach chair position.
详细描述
To evaluate whether the use of non-invasive Hypotension Prediction Index-guided management reduces the duration and severity of intraoperative hypotension, as well as the incidence of intraoperative hypoxia and postoperative complications in patients undergoing arthroscopic shoulder surgery in the beach chair position.
The research team will include patients aged 65 to 90 years undergoing arthroscopic shoulder surgery in the beach chair position. Participants will be randomly assigned to either an HPI-guided group or a standard care group without HPI guidance. The duration and severity of intraoperative hypotension have been compared, as well as the incidence of postoperative complications between the two groups. Patients receiving HPI-guided management are expected to experience fewer and shorter episodes of intraoperative hypotension compared to those without HPI guidance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
patients and outcome assessor were masking
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-emergent shoulder arthroscopy performed in the beach chair position, with eligibility criteria including male or female patients aged 65-90 years.
排除标准
- •Women who are pregnant, planning to become pregnant during the study period, or breastfeeding
- •Individuals with major cardiac diseases, such as severe arrhythmia or heart failure
- •Individuals with significant renal disease, e.g., chronic renal failure requiring dialysis
- •Individuals with a history of stroke
- •Individuals diagnosed with dementia
研究组 & 干预措施
HPI
HPI guidance of hemodynamic management
干预措施: HPI (Device)
control
no HPI guidance of hemodynamic management
干预措施: no HPI (Device)
结局指标
主要结局
the incidence of cerebral desaturation events
时间窗: whole surgery
次要结局
- the time weighted average mean arterial pressure less than 65 mmHg(whole surgery)
研究者
National Taiwan University Clinical Trial Center
Attending anesthesiologist
National Taiwan University Hospital