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

INTERVENTION: Pharmaceutical Form: INN or Proposed INN: OXYGEN Other descriptive name: Medicinal oxygen Concentration unit: % percent Concentration type: equal Concentration number: 35‐ CONDITION: Acute symptomatic pulmonary embolism Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective: Evaluate the efficacy of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate‐Risk pulmonary embolism. Primary end point(s): Modification of the right ventricle (RV) to the left ventricle (LV) diameter ratio measured 48 hours after initiation of therapy Secondary Objective: Evaluate the safety of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate‐Risk pulmonary embolism Timepoint(s) of evaluation of this end point: 48 hours SECONDARY OUTCOME: Secondary end point(s): Modification of the RV to the LV diameter ratio measured 7 days after initiation of therapy. Timepoint(s) of evaluation of this end point: 7 days INCLUSION CRITERIA: 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