Randomized clinical trial to evaluate the efficacy and safety of the treatment with supplementary oxygen in patients with Intermediate-Risk pulmonary embolism (PE) - AIRE

Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal0 个研究点目标入组 100 人开始时间: 2019年6月11日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1) Confirmed PE by multidetector computed tomographic pulmonary angiography (MDCT).
•2) Disfuntion of right ventricle (quotient between RVDD and LVDD > 1.0 in the apical 4-chamber view) in the echocardiogram performed in the first 12 hours after PE diagnosis.
•3) Signed and dated informed consent of the subject.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•1)< 18 years old.
•2)Allergy to iodinated contrast.
•3)Renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula.
•4)Use of chronic oxygen therapy.
•5)Hypercapnia (pCO2 >50 mmHg at the time of diagnosis).
•6)Basal echocardiography technically unsuitable.
•7)Contraindication to anticoagulant therapy.
•8)Symptoms duration >10 days.
•9)Haemodynamic instability.
•10)Participation in other clinical trials for PE treatment during the present clinical trial.
•11)Inability to use mask or nasal prongs.
•12)Life expectancy less than 90 days.

发起方

Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal