Continuous Non-Invasive Blood Pressure Monitoring Versus Intermittent During Spinal Anesthesia in Elderly Patients With Femoral Fracture: Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Duration of hospitalization
研究概览
简要总结
In elderly patients over 65 years of age, proximal femur fracture is the most common type of fracture, and surgical intervention is typically required for the majority of cases. Subarachnoid anesthesia is commonly used for this type of surgery. The objective of this study is to assess the efficacy of continuous non-invasive blood pressure and hemodynamic monitoring compared to traditional methods of blood pressure measurement in reducing the duration of hospitalization and the incidence of post-operative complications in elderly patients undergoing surgery for femur fracture under subarachnoid anesthesia.
详细描述
The proximal femoral fracture is the most frequent fracture in elderly patients over 65 years old, often affected by multiple comorbidities. It is one of the main causes of hospitalization in this population and is associated with high mortality rates.
Surgical treatment is indicated for the majority of fractures, and spinal anesthesia is the most commonly used technique for this type of surgery.
Hypotension is a very common side effect after spinal anesthesia, with a reported incidence of 16%-33%, attributable to a reduction in systemic vascular resistance, cardiac output, or both mechanisms. Several studies have demonstrated the association between intraoperative hypotension, usually defined as a mean arterial pressure <65 mmHg, myocardial and renal organ damage, and 30-day mortality.
In clinical practice oscillometric, non-invasive blood pressure measurement (NIBP) is the first choice of blood pressure monitoring in the majority of low and moderate risk surgeries. This monitoring system is a non-invasive cuff around the upper arm (NIBP-arm), which allows for non-invasive detection of blood pressure values, usually every 5 minutes.
New continuous noninvasive devices to acquire instantaneous arterial blood pressure (ClearSight™, Edwards) may be more sensitive to detect procedural hypotension. Additionally, this system provides advanced hemodynamic parameters not available with traditional oscillometric methods of blood pressure measurement, supporting the anesthesiologist in proactive hemodynamic management of the patient.
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
- 65 Years 至 99 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with American Society of Anesthesiologists (ASA) physical status I-III, candidate for surgical intervention for femoral fracture under spinal anesthesia.
排除标准
- •Severe valvular heart disease
- •Heart failure (New York Heart Association - NYHA class ≥ 3)
- •Vascular system pathologies
- •Allergy or hypersensitivity to local anesthetics
- •Absolute contraindications to spinal anesthesia
- •Patient refusal to participate to the study
结局指标
主要结局
Duration of hospitalization
时间窗: 10-15 days
To compare the length of hospital stay among elderly patients undergoing surgery for femoral fractures under subarachnoid anesthesia, where continuous non-invasive blood pressure monitoring utilizing the ClearSight system is implemented along with a standardized protocol for hemodynamic optimization, with the duration of hospital stay observed in a retrospective cohort of patients undergoing similar surgery but with intermittent (every 5 minutes) non-invasive blood pressure monitoring not linked to a standardized protocol for hemodynamic optimization
次要结局
- Incidence of at least one postoperative complication(10-15 days)