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临床试验/NCT01662141
NCT01662141已完成不适用

Investigation of the Reliability to Measure Cardiac Output by a New Ultrasound Dilution Method in Mechanically Ventilated Children After Pediatric Cardiac Surgery

Transonic Systems Inc.1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2010年2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
33
试验地点
1
主要终点
Measurement of cardiac output by a new ultrasound dilution method in mechanically ventilated children after pediatric cardiac surgery.

研究概览

简要总结

The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper management of severely hemodynamic compromised patients. A new ultrasound dilution method (COstatus) for cardiac output measurement has been developed.

详细描述

The thermodilution technique with a pulmonary artery catheter has been the standard in adult patients for cardiac output measurement. However, using pulmonary artery catheter remains a major clinical problem in children due to technical and size constraints.

COstatus measures changes in blood ultrasound velocity in an extracorporeal AV loop caused by body-temperature isotonic saline injected into the central vein and calculates cardiac output derived from a dilution curve.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
— 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children <15 kg admitted to pediatric cardiac surgery for corrective surgery and mechanically ventilated were eligible for the study if parents provided informed consent.

排除标准

  • Children with known significant tricuspid or mitral valve regurgitations or if it is detected by the preoperative transesophageal echocardiographic examination.
  • Children with persistent severe arrhythmias.
  • Children with remaining intracardiac shunts after surgery, which may adversely affect the measurement.

结局指标

主要结局

Measurement of cardiac output by a new ultrasound dilution method in mechanically ventilated children after pediatric cardiac surgery.

时间窗: Measurements are made during a patient's stay with insitu catheters. The expected average stay is 3-4 days.

To compare cardiac outputs measured with this new ultrasound dilution method with flowmetry (perivascular probe) using ultrasound transit time measured directly on the aorta in children \< 15 kg of weight. Also to assess reliability of COstatus measurements in pediatric patients.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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