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

Sponsor

Ministry of Health, Spain (Other)

Overall Status

Completed

CT.gov ID

NCT04003116

Collaborator

Sociedad Española de Neumología y Cirugía Torácica (Other)

Enrollment

Locations

Arms

36.5

Actual Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Embolism	Drug: Oxygen gas	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 11, 2019

Actual Primary Completion Date :

Apr 24, 2022

Actual Study Completion Date :

Jul 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supplementary oxygen Supplementary oxygen added to conventional anticoagulant treatment.	Drug: Oxygen gas Supplementary oxygen during the first 48 hours added to conventional anticoagulant treatment. Patients will receive anticoagulant treatment according to updated guidelines.
No Intervention: Standard medical therapy Standard management.

Arm

Intervention/Treatment

Experimental: Supplementary oxygen

Supplementary oxygen added to conventional anticoagulant treatment.

Drug: Oxygen gas

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

No Intervention: Standard medical therapy

Standard management.

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital Universitario Araba	Vitoria	Alava	Spain
2	Hospital Galdakao-Usansolo	Galdakao	Vizcaya	Spain
3	Hospital Clínic de Barcelona	Barcelona		Spain
4	Clínica Universidad de Navarra	Madrid		Spain
5	Hospital Universitario Ramón y Cajal	Madrid		Spain
6	Hospital Universitario Virgen del Rocío	Sevilla		Spain
7	Hospital Universitario y Politécnico La Fe	Valencia		Spain

Sponsors and Collaborators

Ministry of Health, Spain
Sociedad Española de Neumología y Cirugía Torácica

Investigators

Study Chair: David Jiménez, IRYCIS, Alcala de Henares University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Jimenez, Pulmonary physician, Ministry of Health, Spain

ClinicalTrials.gov Identifier:

NCT04003116

Other Study ID Numbers:

2019-000266-37

First Posted:

Jul 1, 2019

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Embolism

Embolism

Study Results

No Results Posted as of Aug 18, 2022