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临床试验/NCT04001881
NCT04001881已完成不适用

The Role of Heart Echocardiography in the Prediction of Spinal-induced Hypotension in Elderly Patients With Reduced Left Ventricular Function.

Attikon Hospital1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2019年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61
试验地点
1
主要终点
Predictive value of dIVCmax-to-IVCCI ratio

研究概览

简要总结

Modern guidelines have combined both the maximum diameter of IVC at expiration (dIVC max) and the IVCCI to appreciate right atrial pressure (RAP) measurements and consequently to assess intravascular volume status. In fact, IVC diameter <2.1 cm with IVCCI >20% (quite inspiration) suggests normal RAP of 3mmHg (range, 0-5mmHg), whereas IVC diameter >2.1 cm with IVCCI<20% suggests high RAP of 15mmHg (range, 10-20mmHg). In occasions where the IVC diameter and collapse is not fit the above categories, an intermediate value of 8 mmHg (range, 5-10 mmHg) is applied. From a clinical standpoint, it is conceivable that both measurements must be measured in isolation to enable RAP assessment. To circumvent this limitation the two indices have been consolidated to dIVCmax-to-IVCCI ratio. Although this ratio has been shown high accuracy to predict spinal-induced hypotension in elderly patients with preserved ejection fraction (EF) of the left ventricle (LV), its value in patients with cardiac dysfunction and reduced LV-EF has not been investigated.

From the aforementioned, this study sets out to address the role of dIVCmax-to-IVCCI ratio in the prediction as well as in the management of hypotension after spinal anesthesia in elderly orthopaedic patients with reduced LV-EF.

详细描述

Methods In the present prospective study, consecutive sampling is been used to recruit elderly patients (age>70 years) hospitalized in the Attikon University Hospital of Athens. Patients is included if they sustain orthopaedic operation of the lower limb under spinal anaesthesia. This study was approved for ethics and consent by the Institutional Review Board/Ethics Committee of the authors' institution.

Patients' medical history, physical examination, ECG, and X-ray assessment are standard practice, supplemented by specific exams or tests (e.g. TTE or pro-BNP levels), are performed per the consultant cardiologist's recommendations. All patients included in our study are American Heart Association/American College of Cardiology(AHA/ACC) stage II or III with ejection fraction (EF) of the left ventricle (LV) between 35 and 50%, and their cardiac disease status always in compensated status; also, patients with right ventricle (RV) dysfunction and severe valvular diseases are not included in the study.

A standard intraoperative TTE protocol is used in all patients and included the following views: subcostal 4-chamber (SUBC), apical 4-chamber (4CH), apical 2-chamber (2CH), apical 3-chamber (3CH), parasternal long (LAX) and short axis (SAX).

All data are saved and stored digitally for off-line, postoperative analysis. The EF is determined using the biplane Simpson's method, by performing automated measurements of LV volumes in 2CH and 4CH views (GE, Auto-EF system).

The LV-EF, stroke volume index (SVI), peripheral vascular resistance (PVR), LV filling pressures (E/Em ratio), right ventricle (RV) function (tricuspid annular plane systolic excursion (TAPSE), tricuspid annular systolic velocity (TASV), fractional area change (FAC), the IVCCI and dIVCmax-to-IVCCI ratio were assessed Stroke volume (SV) and subsequent stroke volume index (SVI=SV/m2) of the LV is assessed by using automated measurements of LV volumes, according to the formula: SV= EDV-ESV, where EDV=end-diastolic LV volume and ESV=end-systolic LV volume. From these data, we also derived values for the assessment of cardiac output (CO =SV x HR), subsequent systemic vascular resistance (SVR =MAP x 80/CO), (mean arterial blood pressure=MAP, HR=heart rate).

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
70 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Orthopaedic trauma patients Reduced LV-EF (35% <EF<50%) Elderly patients

排除标准

  • Patients with right ventricle (RV) dysfunction/patients with LV-EF<35%/
  • Severe pulmonary hypertension
  • Tachycardia (heart rate > 100 beats/min), atrial fibrillation.
  • Patients with tricuspid and mitral regurgitation more than grade 2 and those with more than moderate valvular stenosis were excluded.
  • Left ventricular dysynchrony
  • TAPSE index<16 and/orTDI-tricuspid annulus<10 cm/sec and/or Fractional Area Shortening<
  • Spinal block below T-12 level Overt intraoperative haemorhage

研究组 & 干预措施

Hypotension group

spinal anesthesia in Hypotensive patients with low LV-EF Transthoracic echocardiography of IVC before spinal anaesthesia

干预措施: Transthoracic echocardiography (Other)

Hypotension group

spinal anesthesia in Hypotensive patients with low LV-EF Transthoracic echocardiography of IVC before spinal anaesthesia

干预措施: Spinal anesthesia (Drug)

Normotension group

spinal anesthesia IN Normotensive patients with low LV-EF Transthoracic echocardiography of IVC before spinal anaesthesia

干预措施: Transthoracic echocardiography (Other)

Normotension group

spinal anesthesia IN Normotensive patients with low LV-EF Transthoracic echocardiography of IVC before spinal anaesthesia

干预措施: Spinal anesthesia (Drug)

结局指标

主要结局

Predictive value of dIVCmax-to-IVCCI ratio

时间窗: 18 months

Preoperative performance of the dIVCmax-to-IVCCI ratio The main outcome will be the preoperative performance of the dIVCmax-to-IVCCI ratio to foresee the incidence of hypotension after spinal anesthesia in patients with low LV-EF

次要结局

未报告次要终点

研究者

发起方
Attikon Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

THEODOSIOS SARANTEAS

Associate Professor

Attikon Hospital

研究点 (1)

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