跳至主要内容
临床试验/NCT03066388
NCT03066388终止不适用

Accuracy of Pulse Pressure Variations Measured by a Non Invasive Digital Device to Predict Fluid Responsiveness in Patients With Systemic Inflammatory Response Syndrome

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2012年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
6
试验地点
1
主要终点
respiratory variations in noninvasive pulse pressure with respect to the response to fluid

研究概览

简要总结

It has been well established that only 40 to 60% of the patients hospitalized for inflammatory response syndrome (SIRS) positively respond to volume expansion (VE). The fluid responsiveness is usually estimated by assessing VE-induced change in stroke volume (SV). To guide prescriptions and possibly avoid deleterious effects of inappropriate VE, several clinical studies demonstrated that invasive dynamic indices based on heart-lung interactions permit an accurate prediction of the hemodynamic effects induced by VE.

Mechanical ventilation induces cyclic changes in intrathoracic and transpulmonary pressures that transiently affect venous return, right and left ventricular preload, resulting in pronounced cyclic changes in SV in preload-dependent, but not in preload-independent patients. These cyclic changes in SV can be evaluated by the cyclic changes in arterial pulse pressure. Several studies have shown that pulse pressure variation is able to predict fluid responsiveness in patients in the operating room and intensive care unit (ICU).

However, this technique requires percutaneous arterial catheterization, which is associated with several rare but serious complications (thrombosis, infections, pseudoaneurysm,hematoma, and bleeding).

A method for assessing noninvasive arterial blood pressure using an electropneumatic control loop was introduced by Penaz in 1973. Briefly, the blood volume in a finger is measured and kept constant by applying corresponding external pressure. The continuously changing external pressure needed to keep the volume constant directly corresponds to the arterial pressure and, therefore can be used as continuous measurement of arterial blood pressure. Numerous studies evaluating the accuracy of this technology, e.g., Finapres™ (Ohmeda Monitoring Systems, Englewood, CO), and more recently of the Infinity CNAP™ SmartPod (Dräger Medical AG & Co.KG, Lübeck, Germany).

The basic operating principle of the CNAP™ is similar to the Finapres™, but CNAP™ uses multiple control loops. It has recently been shown that CNAP provides real-time estimates of mean arterial blood pressure (MAP) comparable with those measured by an invasive intraarterial catheter system during general anaesthesia.

The accuracy of the measures and the respiratory variations in pulse pressure obtained with the CNAP system have not yet been studied in ICU.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients of the intensive care units of the Lille university-hospital.
  • Age greater than or equal to
  • Patient insured
  • Mechanical ventilation without spontaneous respiratory cycles
  • Regular cardiac rhythm
  • Prescription by the physician in charge of the patients of a 500 mL volume expansion in less than 30 minutes.
  • Patients with sepsis with at least one sign of acute circulatory failure:
  • Tachycardia with heart rate> 100/min
  • systolic blood pressure <90mmHg or a decrease >40mmHg in previously hypertense patient
  • Oliguria <0.5ml/kg/hour for at least one hour
  • skin mottling

排除标准

  • high-grade aortic insufficiency
  • transthoracic echogenicity unsuitable for measuring the stroke volume by echo-Doppler
  • Spontaneous breathing
  • clinical or ultrasonographic evidence of pulmonary edema due to heart failure
  • pregnancy
  • abdominal compartment syndrome
  • Irregular cardiac rhythm

结局指标

主要结局

respiratory variations in noninvasive pulse pressure with respect to the response to fluid

时间窗: during 30 minutes of the volume expansion

次要结局

未报告次要终点

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验