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临床试验/NCT02572739
NCT02572739Unknown不适用

Assessment of Reliability of Cardiac Output Measurement Based on Impedance (NICCOMO) - Method of Noninvasive Cardiac Output Measurement, Compared to Transthoracic Thermodilution (PiCCO) at Different PEEP Levels

Medical University of Gdansk1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Numbers of measurements of haemodynamic parameters (CO, CI, SV, SVV, CI, SVR, SVRI) obtained with impedance, that differ from those obtained with thermodilution

研究概览

简要总结

Thermodilution cardiac output measurement is a reliable method, but it is an invasive one. PiCCO device requires cannulation of central vein and peripheral artery. Impedance method requires only attachment of special electrodes. Non-invasive methods are less accurate. Aim of study is to assess accuracy and reliability of impedance method ( using NICCOMO device) in comparison of thermodilution method ( using PiCCO device) at different PEEP levels.

详细描述

Echocardiography is performed prior to measurement to exclude patients with heart valve abnormalities.

Patients without spontaneous ventilation ( deeply unconscious, sedated or sedated and paralysed), ventilated with controlled mechanical ventilation mode with tidal volume 6-8 ml/ideal body weight, resulting in EtCO2 35-45 mmHg, with PiCCO catheters implemented have additionally NICCOMO device attached. Fraction of inspired oxygen (FiO2) is set to achieve saturation >96% at positive end expiratory pressure (PEEP) 0 cmH2O.

Measurement of cardiac output are performed on expiration at PEEP 0, 5, 10, 15 20 cmH2O and at optimal PEEP (obtained from P-V curve). Simultaneously CO value from impedance device is noted. Other haemodynamic parameters, calculated by both devices are also noted - stroke volume (SV), stroke volume variation (SVV), Cardiac index (CI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • critically ill patients
  • patients on mechanical ventilation
  • circulatory insufficiency (present or in the past) monitored with with PiCCO device

排除标准

  • morbid obesity,
  • short neck,
  • severe pneumonia,
  • inability to NICCOMO electrodes attachment,
  • massive tissue oedema,
  • non-sinus cardiac rhythm,
  • tachycardia,
  • low cardiac output,
  • septic shock,
  • heart valve pathologies,
  • severe atherosclerosis,
  • aortic prosthesis,
  • severe hypertension,
  • extremes of height and weight,
  • intraaortic pump

结局指标

主要结局

Numbers of measurements of haemodynamic parameters (CO, CI, SV, SVV, CI, SVR, SVRI) obtained with impedance, that differ from those obtained with thermodilution

时间窗: up to 90 minutes

measurements taken with impedance and thermodilution simultaneously, at PEEP 0, 5, 10, 15, 20 and at optimal PEEP

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

Magdalena Wujtewicz

assistant professor

Medical University of Gdansk

研究点 (1)

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