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临床试验/NCT02142985
NCT02142985已完成2 期

Respiratory Variation in Central Venous Oxygen Saturation Predicts Volume Responsiveness in Hemodynamically Unstable Patients Under Mechanical Ventilation : a Prospective Cohort Study

University of Monastir1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
88
试验地点
1
主要终点
central venous oxygen saturation (ScvO2) variation

研究概览

简要总结

Vascular filling is the main treatment of hypovolemia. Hypovolemia diagnosis can be difficult in some situations and need to be confirmed with other investigations.

Venous oxymetry based on the ScvO2 values represent a valuable way to predict responsivness to fluid filling maneuver in patients with hemodynamic instability.

详细描述

Vascular filling represent the milestone of the treatment of hypovolemia. Its main objective is to restore vascular volume and correct perfusion issues preventing the deleterious consequences of prolonged shock.

Hypovolemia diagnosis is easy to made in obvious clinical situations such as hemorrhagic shock, deshydratation..., but there still many diagnostic difficulties regarding latent hypovolemia especially if associated with left ventricular dysfunction.

In this situations, diagnostic of hypovolemia is hard to made and other investigations are needed.

Central venous pressure (CVP) and pulmonary occlusion artery pressure (PAPO) are the mainly used parameters for indicating vascular filling but actually many studies underline their low liability in this situation.

After vascular filling, outcome measurment is needed to evaluate the efficacity of the treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

入选标准

  • patients aged above 18 year old
  • hemodynamic instability (hypotension or shock)

排除标准

  • intra cardiac shunt
  • severe arrythmia
  • valvular regurgitation
  • pacemaker
  • pulmonary oedema

研究组 & 干预措施

crystalloid solution

Experimental

vascular filling with 500 ml of crystalloid solution within 10 minutes

干预措施: Sodium Chloride 0.9% Intravenous (Drug)

结局指标

主要结局

central venous oxygen saturation (ScvO2) variation

时间窗: at baseline and after 10 minutes

the ScvO2 is first measured at baseline via a central venous catheter and blood gaz, then after vascular filling (500 ml of colloid solution (Plasmagel) over thirty minutes).

次要结局

未报告次要终点

研究者

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

Pr. Semir Nouira

Professor

University of Monastir

研究点 (1)

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