Comparison of the Diagnostic Performance of the Diastolic Shock Index and Other Shock Indices in Predicting Postspinal Hypotension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 85
- 主要终点
- Development of Postspinal Hypotension
研究概览
简要总结
This prospective observational study aims to evaluate the diagnostic performance of the preoperative Diastolic Shock Index in predicting postspinal hypotension and to compare its performance with other shock indices, including the Shock Index, Modified Shock Index, and Age Shock Index. The study will include patients aged 50 years and older undergoing elective unilateral inguinal hernia surgery under spinal anesthesia. Hemodynamic parameters will be recorded before and after spinal anesthesia as part of routine clinical monitoring. The primary outcome is the development of postspinal hypotension. Secondary outcomes include vasopressor requirement, total ephedrine dose, lowest intraoperative mean arterial pressure, and the diagnostic performance of the evaluated shock indices using receiver operating characteristic curve analysis. No additional intervention beyond routine anesthetic and perioperative care will be performed for study purposes.
详细描述
This prospective observational study will include patients aged 50 years and older undergoing elective unilateral inguinal hernia surgery under spinal anesthesia. The study aims to evaluate the performance of the preoperative Diastolic Shock Index in predicting postspinal hypotension and to compare it with the Shock Index, Modified Shock Index, and Age Shock Index. Baseline systolic, diastolic, and mean arterial pressures and heart rate will be recorded before spinal anesthesia and used to calculate the four shock indices. Hemodynamic parameters will also be recorded at 5, 10, 15, and 20 minutes after spinal anesthesia as part of routine clinical monitoring, without any additional intervention for research purposes.Postspinal hypotension will be defined as a decrease in systolic arterial pressure of at least 25% from baseline and/or a systolic arterial pressure below 90 mmHg. The primary outcome will be postspinal hypotension, while secondary outcomes will include ephedrine requirement, total ephedrine dose, lowest intraoperative mean arterial pressure, and the diagnostic performance of the evaluated indices. Receiver operating characteristic curve analysis will be used to compare the indices and determine the optimal cut-off value for the Diastolic Shock Index, with a minimum of 85 patients planned for inclusion.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 years or older
- •Scheduled for elective unilateral inguinal hernia surgery
- •Scheduled to undergo surgery under spinal anesthesia
- •American Society of Anesthesiologists physical status I-III
- •Provision of written informed consent
排除标准
- •Refusal to participate in the study
- •Emergency surgery
- •Bilateral inguinal hernia surgery
- •Contraindication to spinal anesthesia
- •Failure of spinal anesthesia or conversion to general anesthesia due to failed spinal block
- •Requirement for additional general anesthesia or deep sedation during surgery
- •Operation duration exceeding 120 minutes
- •Atrial fibrillation, atrial flutter, frequent ventricular ectopy, or other arrhythmias preventing reliable heart rate assessment
- •Presence of a permanent cardiac pacemaker
- •Severe valvular heart disease
- •New York Heart Association class III-IV heart failure
- •Preoperative use of vasopressor or inotropic therapy
- •Severe hepatic failure or end-stage renal disease
- •Neurological disease that may significantly affect autonomic nervous system function
- •Preoperative hemodynamic instability, defined as systolic arterial pressure <90 mmHg or >180 mmHg, or heart rate <50 or >120 beats/min
- •Missing study data or inability to obtain records in accordance with the study protocol
研究组 & 干预措施
Patients Who Develop Postspinal Hypotension
Patients who develop postspinal hypotension, defined as a decrease in systolic arterial pressure of 25% or more from baseline and/or a systolic arterial pressure below 90 mmHg following spinal anesthesia.
干预措施: Spinal Anesthesia (Procedure)
Patients Who Do Not Develop Postspinal Hypotension
Patients who do not develop postspinal hypotension, defined as the absence of a decrease in systolic arterial pressure of 25% or more from baseline and a systolic arterial pressure remaining at or above 90 mmHg following spinal anesthesia.
干预措施: Spinal Anesthesia (Procedure)
结局指标
主要结局
Development of Postspinal Hypotension
时间窗: Within the first 20 minutes after spinal anesthesia
Occurrence of postspinal hypotension, defined as a decrease in systolic arterial pressure of 25% or more from baseline and/or a systolic arterial pressure below 90 mmHg following spinal anesthesia.
次要结局
未报告次要终点
研究者
İlke Dolgun
assoc prof
Istinye University