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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Drug: Oxygen gas

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Clínic de Barcelona
  • Madrid, Spain
    • Clinica Universidad de Navarra
  • Madrid, Spain
    • Hospital Universitario Ramon Y Cajal
  • Sevilla, Spain
    • Hospital Universitario Virgen Del Rocio
  • Valencia, Spain
    • Hospital Universitario y Politécnico La Fe
  • Alava
    • Vitoria, Alava, Spain
      • Hospital Universitario Araba
  • Vizcaya
    • Galdakao, Vizcaya, Spain
      • Hospital Galdakao-Usansolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ministry of Health, Spain
• Collaborators: Sociedad Española de Neumología y Cirugía Torácica
• Investigators: Study Chair: David Jiménez, IRYCIS, Alcala de Henares University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 11, 2019
• Primary Completion (ACTUAL): April 24, 2022
• Study Completion (ACTUAL): July 25, 2022

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (ACTUAL): July 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: 2019-000266-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No