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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04003116

Acronym

AIRE

Enrollment

Registered

2019-07-01

Start date

2019-07-11

Completion date

2022-07-25

Last updated

2022-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism

Brief 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.

Interventions

DRUGOxygen gas

Supplementary oxygen during the first 48 hours added to conventional anticoagulant treatment. Patients will receive anticoagulant treatment according to updated guidelines.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Normal right ventricle function at 48 hours	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).

Secondary

Measure	Time frame	Description
Modification RV -LV 7 days	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).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026