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临床试验/NCT03086603
NCT03086603已完成不适用

Prospective Observational Study About Variation of Principal Hemodynamic Parameters, Collected With Non-invasive Monitoring, in Patients Undergoing Spinal Anesthesia for Primary Elective Hip Arthroplasty.

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
stroke volume and stroke volume index

研究概览

简要总结

The study is aimed at observe how spinal anesthesia modifies the hemodynamic state of the patient after optimization to preload independence with a Goal Directed Therapy algorithm guided by non invasive hemodynamic monitoring with Clearsight.

详细描述

This is an observational prospective single group study.

Patients will be monitored with ECG (III leads), non invasive blood pressure cuff (NIBP) cuff, pulse oximetry and Clearsight finger cuff after their arrival in the operating room. Basal Stroke Volume (SV) and indexed Stroke Volume (SVI) will be registered.

The basal value will be optimized according to the study goal directed fluid therapy algorithm: a 200ml fluid challenge will be administered until the SV will increase of at least 10%. When the SV will stop increasing significantly after crystalloid administration, the SV and SVI value will be registered as SVoptimized (SVopt) and SVI optimized (SVIopt), while the same values trigger of the last fluid challenge will be registered as SVtarget1 and SVItarget1. A constant infusion of crystalloids 2 ml/Kg/h will be maintained throughout the study period.

Then, spinal anesthesia will be administered (levobupivacaine 0.5% 0.25mg/kg of ideal weight) in lateral decubitus. After 15 minutes, patients will be turned supine and after 5 minutes SV and SVI will be registered and compared with values SVtarget1 and SVItarget1: if within 10% of range, data will be registered as SVtarget2 and SVItarget2 and patient will maintain basal crystalloid infusion. Otherwise, patients will receive a fluid optimization similar to what described previously before spinal, until values will be within 10% of range of SV and SVI.

Afterwards patients will be transferred to the operating room and will be followed as described in Figure 2. At the end of surgery, patients will be transferred to the Recovery Room and will be monitored and optimized.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • scheduled for elective primary hip arthroplasty
  • scheduled for spinal anesthesia
  • American Society of Anaesthesiologists' (ASA) score 2 or 3
  • aged between 50 and 80 years

排除标准

  • contraindications to neuraxial anaesthesia
  • peripheral vascular abnormalities
  • American Society of Anaesthesiologists' (ASA) score 1, 4 and 5
  • patients' refusal

结局指标

主要结局

stroke volume and stroke volume index

时间窗: duration of spinal anesthesia procedure

stroke volume and stroke volume index variation after spinal anesthesia

次要结局

  • cardiac output and cardiac index(duration of spinal anesthesia procedure)
  • peripheral vascular resistance index (SVRI)(duration of spinal anesthesia procedure)
  • episodes of hypotension and hypertension intraoperatively(duration of surgery)

研究者

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

Daniela Ghisi

principal investigator

Istituto Ortopedico Rizzoli

研究点 (1)

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