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临床试验/NCT04483765
NCT04483765Unknown不适用

Does Shock Index, Modified Shock Index and Age-Related Shock Index Have a Predictive Value in Predicting the Risk of Post-spinal Hypotension in Elderly Patients

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
SI

研究概览

简要总结

Aim of this prospective observational study is to investigate whether shock index(SI), modified shock index(MSI) and age related shock index(ASI) have any predictive value in predicting post-spinal hypotension which may develop in patients over 65 years of age, who are planned to undergo transurethral resection of the prostate (TURP) and transurethral resection of the bladder (TURB) surgery under spinal anesthesia.

详细描述

During the aging process, many important changes occur in the cardiovascular system. In elderly patients undergoing surgery, systemic vascular resistance is generally high but accompanying dehydration is a very common condition. The hemodynamic status of these patients may be compromised during spinal anesthesia due to the decrease in both systemic vascular resistance (SVR) and cardiac preload. Intraoperative hypotension may develop after spinal anesthesia. Intraoperative hypotension can prolong hospital stay by causing serious complications, and it can significantly affect mortality rates. Predicting hypotension which may develop after spinal anesthesia, can save time to decide, prepare and apply preventive interventions.

Shock index (SI) has been defined as the ratio of heart rate (HR) to systolic blood pressure (SBP). SI is an easy and non-invasive marker used in hypovolemia and early diagnosis of shock. SI is usually <0.7. In case of acute hypovolemia and circulatory failure, this ratio increases. It has been stated that in critical patients, diastolic blood pressure (DBP) will drop earlier than SBP, and the mean blood pressure will be a more accurate marker to assess the severity of the disease. For this reason, the modified shock index (MSI), which is obtained by dividing the heart rate by the mean arterial pressure (MAP), has been defined. MSI> 1.3 indicates a hypodynamic state.

The Age Shock Index (ASI) is defined by multiplying SI by age. In trauma patients, this index has been shown to correlate with a higher mortality rate with an increase greater than 50. Since age affects the physiological reserve negatively, it has been stated that ASI is a better predictor of 48-hour mortality compared to heart rate, SBP or SI. In studies evaluating ASI, SI and MSI to predict post-intubation hypotension; pre-intubation SI, MSI, ASI values have been shown to be the independent predictors of post-intubation hypotension.

Aim of this prospective observational study is to investigate whether SI, MSI and ASI have any predictive value in predicting post-spinal hypotension which may develop in patients over 65 years of age, who are planned to undergo transurethral resection of the prostate (TURP) and transurethral resection of the bladder (TURB) surgery under spinal anesthesia.

The secondary objective is to compare the two groups in terms of preoperative and postoperative blood tests, and to determine whether the patients were admitted to intensive care or postanesthesia care unit. If the patient was admitted, length of unit and hospital stay and postoperative complications (if developed any) will be recorded. In addition, the investigators will examine whether intraoperative hypotension has any negative effects.

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 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥65 years old

排除标准

  • duration of operation>120 minutes ASA>3
  • Patients with valvular heart disease that disrupts hemodynamics
  • Patients with arrhythmia (such as atrial fibrillation with rapid ventricular rate) that disrupts hemodynamics
  • severe heart failure
  • mental and motor problems
  • neuropsychiatric disorders

结局指标

主要结局

SI

时间窗: preoperative

shock index: defined as the ratio of heart rate (HR) to systolic blood pressure (SBP)

MSI

时间窗: preoperative

Modified Shock İndex: obtained by dividing the heart rate by the mean arterial pressure

ASI

时间窗: preoperative

Age Shock Index (ASI) is defined by multiplying shock index(SI) by age

次要结局

  • CCI(preoperative)
  • length of hospital stay(through study completion, an average of 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ismail aytaç

Principal Investigator

Ankara City Hospital Bilkent

研究点 (1)

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