Randomized Clinical Trial to Evaluate the Efficacy and Safety of the Treatment With Supplementary Oxygen in Patients With Intermediate-Risk Pulmonary Embolism (PE)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 7
- Primary Endpoint
- Normal right ventricle function at 48 hours
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Supplementary oxygen
Supplementary oxygen added to conventional anticoagulant treatment.
Intervention: Oxygen gas (Drug)
Outcomes
Primary Outcomes
Normal right ventricle function at 48 hours
Time Frame: 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).
Secondary Outcomes
- Modification RV -LV 7 days(7 days)
Investigators
David Jimenez
Pulmonary physician
Ministry of Health, Spain