Randomized Clinical Trial to Evaluate the Efficacy and Safety of the Treatment With Supplementary Oxygen in Patients With Intermediate-Risk Pulmonary Embolism (PE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- Normal right ventricle function at 48 hours
研究概览
简要总结
The primary objective is to evaluate the efficacy of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism.
The secondary objective is to evaluate the safety of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Confirmed PE by multidetector computed tomographic pulmonary angiography (MDCT).
- •Disfunction of right ventricle (RV to left ventricle [LV] diameter ratio >1.0 in the apical 4-chamber view) in the echocardiogram performed in the first 12 hours after PE diagnosis.
- •Signed and dated informed consent of the subject.
排除标准
- •<18 years old.
- •Allergy to iodinated contrast.
- •Renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula.
- •Use of chronic oxygen therapy.
- •Hypercapnia (pCO2 >50 mmHg at the time of diagnosis).
- •Technically inadequate basal echocardiography.
- •Contraindication to anticoagulant therapy.
- •Symptoms duration >10 days.
- •Haemodynamic instability.
- •Participation in other clinical trial for PE treatment during the present clinical trial.
- •Inability to use mask or nasal prongs.
- •Life expectancy less than 90 days.
研究组 & 干预措施
Supplementary oxygen
Supplementary oxygen added to conventional anticoagulant treatment.
干预措施: Oxygen gas (Drug)
结局指标
主要结局
Normal right ventricle function at 48 hours
时间窗: 48 hours
Right ventricle (RV) to left ventricle (LV) diameter ratio equal or less than 1.0 measured 48 hours after initiation of therapy in normotensive patients with intermediate-risk pulmonary embolism (PE).
次要结局
- Modification RV -LV 7 days(7 days)
研究者
David Jimenez
Pulmonary physician
Ministry of Health, Spain