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

• Status: Recruiting
• Trial end date: 2022-07-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ministry of Health, Spain
• Collaborator: Sociedad Española de Neumología y Cirugía Torácica
• Treatments: Anticoagulants

Criteria

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.