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

Phase 3

Completed

• Conditions: Pulmonary Embolism
• Interventions: Drug: Oxygen gas

• Registration Number: NCT04003116
• Lead Sponsor: Ministry of Health, Spain

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-06-27
• Study First Posted: 2019-07-01
• Study Start: 2019-07-11
• Primary Completion: 2022-04-24
• Study Completion: 2022-07-25
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supplementary oxygen	Oxygen gas	Supplementary oxygen added to conventional anticoagulant treatment.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (7)

Hospital Universitario Araba; 🇪🇸 Vitoria, Alava, Spain

Hospital Galdakao-Usansolo; 🇪🇸 Galdakao, Vizcaya, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Clínica Universidad de Navarra; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario y Politécnico La Fe; 🇪🇸 Valencia, Spain