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临床试验/NCT01944254
NCT01944254已完成不适用

Comparison of the Precision of Cardiac Output-measures at Random to Respiration, Synchronised With Expiration and Instructed Slow Exhalation, Obtained by Pulmonal Artery Catheter Thermodilution Technique With Cold Injection

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2013年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
The observed variance amongst the cardiac output measures

研究概览

简要总结

The intention of this study is to determine whether the precision of the measure of cardiac output can be optimized by conducting the measurement while the participant is instructed to exhale slowly. This will be compared to measurements done at random to respiration and timed with the participant's spontaneous expiration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Every patient that receives a pulmonary artery catheter (PAC) related to elective cardiac surgeries,
  • •informed and written consent to participation in the study in accordance with the Helsinki declaration
  • •hemodynamic stability

排除标准

  • •Hemodynamical instability
  • •atrial fibrillation
  • •tricuspid insufficiency ≥ grade 2
  • •hemodialysis or other conditions where extra volume load can be negative,
  • •lack of ability to give a written consent to participate in the study

研究组 & 干预措施

random to respiration

Active Comparator

Cardiac output measurement at random to respiration

干预措施: Cardiac output measurement at random to respiration (Procedure)

timed with expiration start

Experimental

Cardiac output measurement synchronised at start of expiration.

干预措施: Cardiac output measurement synchronised at start of expiration (Procedure)

timed to instructed exhalation

Experimental

Cardiac output measurement timed to instructed exhalation. The patient will receive instructions to exhale slowly using a peak expiratory flow (PEF)-flute and the cardiac output measurement will be started (i.e bolus given) at the start of expiration.

干预措施: Cardiac output measurement timed to instructed exhalation (Procedure)

结局指标

主要结局

The observed variance amongst the cardiac output measures

时间窗: 1 hour

The measures will be obtained the first postoperative morning by pulmonary artery catheter thermodilution technique. In total 24 measurements will be done in each patient, i.e 8 measurements in each interventional series described later. The variance observed will create the foundation for calculating the precision of the measures.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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