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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-11

Study Completion Date

2022-07-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supplementary oxygen

Supplementary oxygen added to conventional anticoagulant treatment.

Group Type EXPERIMENTAL

Oxygen gas

Intervention Type DRUG

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

Standard medical therapy

Standard management.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oxygen gas

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No