跳至主要内容
临床试验/NCT02757573
NCT02757573已完成不适用

The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery - Assessment With Pulmonary Arterial Catheter and Transesophageal Echocardiography Measurements

Tampere University Hospital2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2016年4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
31
试验地点
2
主要终点
Tricuspid annular plane systolic excursion (TAPSE)

研究概览

简要总结

The aims of the study is to investigate the right ventricular responses to mild hypercarbia after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial catheter and transesophageal echocardiography.

详细描述

The aims of the study is to investigate the right ventricular responses to mild hypercarbia after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial catheter and transesophageal echocardiography. Investigators hypothesize that induced mild hypercarbia (PaCO2 7.5 kPa) cause elevated mean pulmonary arterial pressure and pulmonary vascular resistance, and this reflect to the right ventricle, both volume and function. And this right ventricle effect could be noticed by echocardiography.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • scheduled mitral valve prolapse repair surgery
  • able to give informed consent

排除标准

  • preoperative right ventricular dysfunction or pulmonary hypertension
  • significant tricuspid regurgitation
  • congenital heart defect
  • ventricular dyssynchrony or wide QRS-complex on ECG (> 130 ms)
  • prior myocardial infarction (within tree months) or pericardial constriction
  • preoperative left ventricular (LV) dysfunction, i.e. LV ejection fraction under 40 %
  • if the scheduled repair by plastic procedure has been converted to mitral valve replacement

结局指标

主要结局

Tricuspid annular plane systolic excursion (TAPSE)

时间窗: Change from baseline TAPSE at hypercarbia (in approximately 30 min)

TAPSE will be measured at baseline (PaCO2 5 kPa) and at hypercarbia (PaCO2 7.5 kPa)

Mean pulmonary artery pressure (MPAP)

时间窗: Change from baseline MPAP at hypercarbia (in approximately 30 min)

MPAP will be measured at baseline (PaCO2 5 kPa) and at hypercarbia (PaCO2 7.5 kPa)

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

Kati Järvelä

MD, PhD

Tampere University Hospital

研究点 (2)

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