Study to evaluate the use of supplemental oxygen in patients with acute symptomatic pulmonary embolism.

Randomized clinical trial to evaluate the efficacy and safety of the treatment with supplementary oxygen in patients with Intermediate-Risk pulmonary embolism (PE) - AIRE

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000266-37-ES

Enrollment

100

Registered

2019-06-11

Start date

2019-06-21

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute symptomatic pulmonary embolism

Interventions

Pharmaceutical Form: INN or Proposed INN: OXYGEN Other descriptive name: Medicinal oxygen Concentration unit: % percent Concentration ty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Confirmed PE by multidetector computed tomographic pulmonary angiography (MDCT). 2) Disfuntion of right ventricle (quotient between RVDD and LVDD > 1.0 in the apical 4-chamber view) in the echocardiogram performed in the first 12 hours after PE diagnosis. 3) Signed and dated informed consent of the subject. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: 1) 50 mmHg at the time of diagnosis). 6) Basal echocardiography technically unsuitable. 7) Contraindication to anticoagulant therapy. 8) Symptoms duration >10 days. 9) Haemodynamic instability. 10) Participation in other clinical trials for PE treatment during the present clinical trial. 11) Inability to use mask or nasal prongs. 12) Life expectancy less than 90 days.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the efficacy of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-Risk pulmonary embolism.;Secondary Objective: Evaluate the safety of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-Risk pulmonary embolism;Primary end point(s): Modification of the right ventricle (RV) to the left ventricle (LV) diameter ratio measured 48 hours after initiation of therapy;Timepoint(s) of evaluation of this end point: 48 hours	—

Measure

Time frame

Main Objective: Evaluate the efficacy of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-Risk pulmonary embolism.;Secondary Objective: Evaluate the safety of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-Risk pulmonary embolism;Primary end point(s): Modification of the right ventricle (RV) to the left ventricle (LV) diameter ratio measured 48 hours after initiation of therapy;Timepoint(s) of evaluation of this end point: 48 hours

—

Secondary

Measure	Time frame
Secondary end point(s): Modification of the RV to the LV diameter ratio measured 7 days after initiation of therapy.;Timepoint(s) of evaluation of this end point: 7 days	—

Countries

Spain

Contacts

Public ContactClinical Trials information

S&H Medical Science Service

almudena.sanchez@shmedical.es34915357183

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026