Air Versus Oxygen for Intermediate-Risk Pulmonary Embolism (AIRE)

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Clinical Trial to Evaluate the Efficacy and Safety of the Treatment With Supplementary Oxygen in Patients With Intermediate-Risk Pulmonary Embolism (PE)

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Drug: Oxygen gas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: <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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplementary oxygen<br>Supplementary oxygen added to conventional anticoagulant treatment. | Drug: Oxygen gas<br>* Supplementary oxygen during the first 48 hours added to conventional anticoagulant treatment. Patients will receive anticoagulant treatment according to updated guidelines.<br>|
| No Intervention: Standard medical therapy<br>Standard management. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal right ventricle function at 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). | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modification RV -LV 7 days | Modification of the right ventricle (RV) to the left ventricle (LV) diameter ratio measured 7 days after initiation of therapy in normotensive patients with intermediate-risk pulmonary embolism (PE). | 7 days |