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

Ministry of Health, Spain

Status and phase

Completed

Phase 3

Conditions

Pulmonary Embolism

Treatments

Drug: Oxygen gas

Study type

Interventional

Funder types

Other

Identifiers

NCT04003116

2019-000266-37

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.