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Taking peoplePhase 3

Extra oxygen for people with acute pulmonary embolism of intermediate risk

Tests extra oxygen in adults with intermediate-risk acute pulmonary embolism, checked at day 30.

Key facts

Who runs it
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal
Where
Italy and Spain49 sites in 2 countriesChoose a country to see its sites
Registry title
Registry-based randomized trial to determine the role of Oxygen in acute Pulmonary Embolism
Status
Recruiting
Phase
Phase 3
People taking part
4,050 people, planned
Started
1 Jul 2024
Expected to end
1 Aug 2028
Type of study
Interventional
Record updated
19 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a recent blood clot in the lungs (pulmonary embolism) and an enlarged right side of the heart. It tests extra oxygen.

Age
18 years and older
Sex
All sexes
Disease stage
Intermediate-risk acute pulmonary embolism, confirmed by a CT scan of the lung blood vessels. The right heart chamber must be enlarged: right ventricle/left ventricle ratio >1.0 on CT or heart ultrasound.
Earlier treatment
People who use long-term oxygen therapy cannot join.

Main reasons for not taking part

  • Oxygen saturation of less than 90% on a finger sensor at diagnosis
  • Known high carbon dioxide in the blood (pCO2 >50 mmHg)
  • More than 10 days since the pulmonary embolism was diagnosed
  • Collapse of blood circulation at diagnosis, such as needing resuscitation or very low blood pressure
  • Cannot take blood thinners, expected to live <90 days, or cannot use a mask or nasal tubes

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Pulmonary embolism confirmed by multidetector computed tomographic pulmonary angiography
  • Right ventricular enlargement confirmed by computed tomography (transverse view) or echocardiography (apical or subcostal four chamber) where the right ventricle/left ventricle ratio is >1.0

Who cannot take part

  • Participating in any other investigational drug or device study
  • Use of chronic oxygen therapy
  • Contraindication to anticoagulant therapy according to the physician judgement
  • Age less than 18 years
  • Life expectancy <90 days at the discretion of the enrolling clinician
  • Oxygen saturation of less than 90% on pulse oximetry at the time of diagnosis
  • Technically inadequate basal computed tomography or echocardiography that prohibits the measurement of the right and left ventricle dimensions
  • Known hypercapnia (pCO2 >50 mmHg on arterial blood gases) at the time of diagnosis
  • Time elapsed since index diagnosis of pulmonary embolism symptom >10 days
  • Hemodynamic collapse at the time of PE diagnosis, defined as: need for cardiopulmonary resuscitation; or systolic blood pressure <90 mmHg for at least 15 min, or drop of systolic blood pressure by at least 40 mmHg for at least 15 min with signs of end organ hypoperfusion (cold extremities or low urinary output <30 mL/h or mental confusion); or need for catecholamine administration to maintain adequate organ perfusion and a systolic blood pressure of >90 mmHg
  • Inability to use mask or nasal prongs

This trial has no sites in United States.

It has sites in 2 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

To evaluate the efficacy of supplemental oxygen in patients with intermediate-risk acute pulmonary embolism at day 30.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Registry-based randomized trial to determine the role of Oxygen in acute Pulmonary Embolism
Plain-language title
Extra oxygen for people with acute pulmonary embolism of intermediate riskGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
19 October 2026