NCT04025086已完成不适用
Perioperative Goal Directed Therapy (PGDT) in Spinal Surgery in the Prone Position: Optimization of Fluid Therapy, Haemodynamic Impact and on Post-operative Complications
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Frequency rate of early post-operative complications
研究概览
简要总结
This study aims at evaluating if a specific protocol, that can be framed in the innovative concept of Perioperative Goal Directed Therapy (PGDT), based on the evaluation of the Stroke Volume Variation (SVV) - a parameter deriving from the adoption of a minimally invasive advanced hemodynamic monitoring technology with a special sensor called FloTrac® (Edwards) or of a non-invasive monitoring system with the Clearsight® sensor (Edwards) - is able to guarantee a greater precision in the intraoperative management of patients undergoing spinal surgery in prone position.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-80 years
- •American Society of Anesthesiologists(ASA) Classification I-II-III
- •Minor and major spinal surgery
- •Prone position
- •Sinus rhythm
- •Absence of atrial fibrillation. or severe arrhythmia
- •Informed consent
排除标准
- •Absence of informed consent
- •Age less than 18 or older than 80 years
- •Cardiac rhythm abnormalities: atrial fibrillation and / or severe arrhythmia
结局指标
主要结局
Frequency rate of early post-operative complications
时间窗: 7 days
次要结局
- Comparison between the two commonly adopted anesthetic techniques (totally intravenous anesthesia (TIVA / TCI) or balanced anesthesia) in terms of intraoperative management of the patient and post-operative complication(7 days)
研究者
Marinella Astuto
Full Professor
University of Catania
研究点 (1)
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