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

Pulmonary Embolism Clinical Trial

— AIRE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003116
• Other study ID #: 2019-000266-37
• Status: Completed
• Phase: Phase 3
• Start date: July 11, 2019
• Est. completion date: July 25, 2022

Study information

• Verified date: August 2022
• Source: Ministry of Health, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 25, 2022
• Est. primary completion date: April 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Drug:
• Oxygen gas
Supplementary oxygen during the first 48 hours added to conventional anticoagulant treatment. Patients will receive anticoagulant treatment according to updated guidelines.

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Galdakao-Usansolo	Galdakao	Vizcaya
Spain	Clínica Universidad de Navarra	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universitario y Politécnico La Fe	Valencia
Spain	Hospital Universitario Araba	Vitoria	Alava

Sponsors (2)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal right ventricle function at 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).	48 hours
Secondary	Modification RV -LV 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).	7 days