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临床试验/NCT05236426
NCT05236426Unknown不适用

Comparison of Cardiac Index (CI) Measurements Performed With Use of the Bioreactance Technology and Transpulmonary Thermodilution in Reference to Measurements Based on Echocardiography.

University of Warmia and Mazury in Olsztyn0 个研究点目标入组 50 人开始时间: 2022年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
Cardiac Index value measured by the transpulmonary thermodilution technique

研究概览

简要总结

The aim of the study is to determine the correlation of the results of cardiac index (CI) measurements performed with use of bioreactance technology with the results of measurements made with the use of transpulmonary thermodilution. Both methods will be evaluated in reference to measurements based on echocardiography.

详细描述

After approval of the study design by the institutional ethics committee, 50 critically ill adult patients (requiring haemodynamic monitoring and mechanical ventilation) treated in the ICU for a intracranial pathology will be enrolled in the study.

Exclusions: Age under 18, presence of pleural effusion or pericardium (confirmed by chest X-ray and / or ultrasound / echocardiography), presence of aortic / mitral valve disease, presence of an implanted pacemaker CI measurements will be performed simultaneously for 5 minutes. The CI value measured by the transpulmonary thermodilution technique will be obtained with the PiCCO system (Pulsiocat PV8115; Pulsion Medical Systems, Feldkirchen, Germany). Measurements will be made three times within 5 minutes. For statistical purposes, the value of the arithmetic mean of the obtained results will be used.

The CI value as measured by the bioreactance method will be determined using the monitor: Starling Fluid Management System (Baxter International Inc, USA). This monitor uses bioreactance technology to determine hemodynamic parameters and bioimpedance technology to measure thoracic fluid content (TFC). The test data will be recorded with two pairs of electrodes placed on the chest according to the manufacturer's instructions. Measurements documented at 30-second intervals will concern 10 measurement cycles. The average of the obtained results will be subjected to statistical analysis.

Echocardiographic examination of the heart to determine the value of CI will be performed by one (always the same) qualified (certified in echocardiographic examinations) clinician.

Echocardiographic measurements will begin with determining the diameter of the left ventricular outflow tract (left ventricular outflow tract cross-sectional area, LVOT-CSA). Then, three subvalvular velocity time integral (LVOT-VTI) measurements will be made over the course of 5 minutes. This measurement will be performed in the apical five-chamber projection.

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

入选标准

  • 50 critically ill adult patients (requiring haemodynamic monitoring and mechanical ventilation) treated in the ICU for a intracranial pathology

排除标准

  • Age under 18
  • Presence of pleural effusion or pericardium (confirmed by chest X-ray and / or ultrasound / echocardiography)
  • Presence of aortic / mitral valve pathology
  • Presence of an implanted pacemaker

结局指标

主要结局

Cardiac Index value measured by the transpulmonary thermodilution technique

时间窗: The results of three measurements will be documented within five minutes

The cardiac index is expressed with units : Liters/minute/meter2

Cardiac index value determined with use an ultrasound technique (echocardiography)

时间窗: The results of three measurements will be documented within five minutes

The cardiac index is expressed with units : Liters/minute/meter2

Cardiac Index value measured with use of bioreactance technology

时间窗: The results of ten measurements at intervals of 30 seconds will be documented within five minutes

The cardiac index is expressed with units : Liters/minute/meter2

次要结局

未报告次要终点

研究者

发起方
University of Warmia and Mazury in Olsztyn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan Adamski

Principal Investigator

University of Warmia and Mazury in Olsztyn

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