Performance Diagnosis of a Patent Foramen Ovale During Lung Transplantation Using Transesophageal Echocardiography: Comparison of the Injection of Contrast in the Upper and Lower Caval Territories (FOP-TP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of transatrial passage of contrast media
研究概览
简要总结
The investigators hypothesis is that an injection into the inferior vena cava associated with a provocation maneuver should allow to increase the incidence of FOP found by transesophageal echocardiography in a population of patients undergoing lung transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years old minimum
- •Benefiting from a lung transplant
- •Having an upper vena cava catheter and a lower vena cava catheter set up as part of the usual care
- •Having signed a consent form
- •Affiliated to a insurance scheme or beneficiary (excluding AME)
排除标准
- •Pregnant or lactating women
- •Having a contraindication to the insertion of the esophageal ultrasound probe
- •deprived of liberty or under guardianship
研究组 & 干预措施
superior without positive tele-expiratory pressure
Diagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation without positive tele-expiratory pressure
干预措施: search for a patent foramen ovale (Diagnostic Test)
superior with 10 cmH2O positive tele-expiratory pressure
Diagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure
干预措施: search for a patent foramen ovale (Diagnostic Test)
inferior without positive tele-expiratory pressure
Diagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation without positive tele-expiratory pressure
干预措施: search for a patent foramen ovale (Diagnostic Test)
inferior with 10 cmH2O positive tele-expiratory pressur
Diagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure
干预措施: search for a patent foramen ovale (Diagnostic Test)
结局指标
主要结局
Incidence of transatrial passage of contrast media
时间窗: 1 day after lung transplantation
Incidence of transatrial passage of contrast media
次要结局
- Size of PFO, existence of an atrial septal aneurysm(1 day after lung transplantation)
- Number of postoperative days with mechanical ventilation(30 days after lung transplantation)
- Mortality during the stay in the hospital(30 days after lung transplantation)
- Mortality at the postoperative 30-day(30 days after lung transplantation)
- Incidence of pulmonary graft dysfunction, incidence of stroke, incidence of myocardial ischemia(30 days after lung transplantation)
- Mortality during the stay in the intensive care unit(30 days after lung transplantation)