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

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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Araba, Vitoria-Gasteiz, Alava, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxygen gas

Drug

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

Primary outcomes

Normal right ventricle function at 48 hours

Time frame: 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 outcomes

Modification RV -LV 7 days

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Ministry of Health, Spain

Other Gov

Collaborators

Sociedad Española de Neumología y Cirugía Torácica

Registry information

Official study title

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

Acronym: AIRE

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Jul 1, 2019
Registry last updated: Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed