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临床试验/NCT04993612
NCT04993612招募中不适用

Blood Gas Analysis Obtained in Pulmonary Capillary Wedge Position During Right Heart Catheterization

Ayham Daher1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年6月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Between group differences

研究概览

简要总结

If pulmonary hypertension is suspected, a right heart catheterization is usually performed to confirm or rule out the diagnosis. As part of this examination, blood samples are taken from various locations as standard and blood gas analyses are performed. One of the most important measurements during the right heart catheterization is the measurement of the pulmonary arterial occlusion pressure by the so-called wedge maneuver. To measure this value, the catheter with inflated balloon must be advanced into the pulmonary vessels until the "wedge" position is reached, i.e. the balloon completely occludes a branch of the pulmonary artery. In this study, the investigators want to characterize patients with pulmonary hypertension of different causes in more detail. To do that, two blood samples (totaling approximately 4 mL of blood, one sample directly after occlusion and the other one two minutes later) will be drawn during the right heart catheterization from the above-mentioned "wedge" position", behind the inflated balloon, and blood gas analyses will be performed on these samples. In addition, various clinical parameters (comorbidities, etc.) will be recorded by means of clinical questionnaires. Follow-up data will be analyzed and correlations with the aforementioned blood gas analyses will be examined. The results of the study will be used to more precisely characterize the still vague concept of secondary pulmonary hypertension. This could help to develop new therapeutic strategies in some subgroups in the future.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have a clearly defined indication for Right heart catheterization.
  • Age > 18 years
  • Informed consent for participation in the study will sign

排除标准

  • Individuals who are not fully capable of giving consent and understanding the nature, significance, and scope of the study
  • Pregnancy and lactation
  • Wedge-BGA not possible

研究组 & 干预措施

No pulmonary Hypertension

干预措施: Blood gas analysis (Diagnostic Test)

pulmonary Hypertension Group 1

干预措施: Blood gas analysis (Diagnostic Test)

pulmonary Hypertension Group 2

干预措施: Blood gas analysis (Diagnostic Test)

pulmonary Hypertension Group 3

干预措施: Blood gas analysis (Diagnostic Test)

pulmonary Hypertension Group 4

干预措施: Blood gas analysis (Diagnostic Test)

pulmonary Hypertension Group 5

干预措施: Blood gas analysis (Diagnostic Test)

结局指标

主要结局

Between group differences

时间窗: At the time of recruitment

Differences in the Wedge-BGA between groups

次要结局

  • Follow-up(1 and 5 years)

研究者

发起方
Ayham Daher
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ayham Daher

Principal Investigator

RWTH Aachen University

研究点 (1)

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