The Effect of Frailty to Intraoperative Hemodynamic Instability and Perioperative Complications in the Elderly: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Incidence of intraoperative hypotension
研究概览
简要总结
With the progression of population aging, the number of elderly patients undergoing surgery is increasing as well. However, as the condition of health differs greatly between individual elderly patients even of the same age, it is a necessity to evaluate elderly patients thoroughly and individually for better management of perioperative care.
Frailty is a condition in which patients are impaired at physical reserve and homeostatic control. Frail elderly people are at higher risk of morbidity and mortality after exposure to a stressor. Frail patients are at higher risk of perioperative complications and longer hospital stay. However, there has been no standard criteria or tool to evaluate frailty in the elderly. Neither has there been enough evidence explaining the mechanism between frailty and increased perioperative complications. Therefore, in this study we aim to discover the relationship between frailty and intraoperative hemodynamic instability, as well as perioperative complications in the elderly patients, hoping to find an adequate and practical model for preoperative assessment in the elderly hopefully for better perioperative outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age≥65 years
- •elective major non-cardiac surgery
- •general anesthesia
- •American Society of Anesthesiologists(ASA) grade I,II,III
- •study protocol fully understood by the patients, written consent obtained
排除标准
- •emergency surgery
- •in active state of infection or inflammation
- •chronic kidney disease(CKD) stage 5
- •having conditions that would interfere accurate measurement of upper extremity blood pressure (e.g. subclavian artery stenosis)
- •having conditions that would interfere assessment of frailty assessment (e.g. mental disorder, hearing disorder)
- •study protocol not fully understood, no written consent obtained
结局指标
主要结局
Incidence of intraoperative hypotension
时间窗: Intraoperative
Intraoperative hypotension includes post induction hypotension(PIH), early intraoperative hypotension(eIOH) and late intraoperative hypotension(lIOH). Hypotension is defined as a systolic blood pressure less than 90mmHg or a relative decrease more than 30% compared to baseline blood pressure, or mean arterial pressure less than 65mmHg or a decrease more than 30% compared to baseline. PIH is defined as a hypotension within 20 minutes after anesthesia induction, or before surgical incision. eIOH is defined as hypotension within 30 minutes after the start of surgery. lIOH is defined as hypotension that happen 30 minutes after the start of surgery until the end of surgery.
Incidence of intraoperative hemodynamic instability
时间窗: Intraoperative
Intraoperative hemodynamic instability is defined as a definite change of systolic blood pressure, or mean arterial pressure, or diastolic pressure, or pulse pressure more than 15% or the need for vasoactive agents.
次要结局
- Incidence of postoperative complications(Within 30days after surgery)