跳至主要内容
临床试验/2025-520808-10-00
2025-520808-10-00招募中3 期

Role of inhaled nitric oxide on right ventricular function and pulmonary vascular mechanics following cardiac surgery

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年1月24日最近更新:

试验速览

阶段
3 期
状态
招募中
入组人数
50
试验地点
2
主要终点
Parameters of right ventricular function

研究概览

简要总结

To study the effects of inhaled iNO on pulmonary vascular mechanics, right ventricular function, and right ventricular-vascular coupling in patients in the immediate cardiac surgery post-operative period

入排标准

年龄范围
18 years 至 65+ years(65+ Years, 18-64 Years)
接受健康志愿者

入选标准

  • Obtained informed consent
  • Age > 18 years
  • Under passive mechanical ventilation
  • Pre-operative FEVI ≥ 30%
  • Absence of hypovolemia: absence of ventricular "kissing" and / or superior vena cava collapsibility index < 20%
  • Stable spontaneous heart rythm
  • Post-operative hemodynamic stability

排除标准

  • Cor pulmonale or presence of preoperative pulmonary vascular pathology
  • Chronic pulmonary hypertension (mPAP> 35 mmHg) related to advanced COPD or chronic thromboembolic disease
  • Surgery involving the tricuspid or pulmonary valves
  • Intra- or post-operative use of nitroprusside or nitroglycerine
  • Pre-operative dependence of inotropic drugs or vasoconstrictors
  • Use of levosimendan. If dobutamine is in use, patients can be included provided the infusion can be stopped or is ≤ 1 µg/kg/min
  • Pacemaker dependency

结局指标

主要结局

Parameters of right ventricular function

Parameters of right ventricular function

次要结局

  • Results of the electrical impedance tomography (EIT): regional distribution of ventilation and perfusion and EIT pulsatility

研究者

申办方类型
Laboratory/Research/Testing facility
责任方
Principal Investigator
主要研究者

Isabel Magaña Bru

Scientific

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa

研究点 (2)

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