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| Name | Class |
|---|---|
| Sociedad Española de Neumología y Cirugía Torácica | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplementary oxygen | Experimental | Supplementary oxygen added to conventional anticoagulant treatment. |
|
| Standard medical therapy | No Intervention | Standard management. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen gas | Drug | Supplementary oxygen during the first 48 hours added to conventional anticoagulant treatment. Patients will receive anticoagulant treatment according to updated guidelines. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Jiménez | IRYCIS, Alcala de Henares University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Araba | Vitoria-Gasteiz | Alava | Spain | |||
| Hospital Galdakao-Usansolo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37717936 | Derived | Barrios D, Duran D, Rodriguez C, Moises J, Retegui A, Lobo JL, Lopez R, Chasco L, Jara-Palomares L, Muriel A, Otero-Candelera R, Ruiz-Artacho P, Monreal M, Bikdeli B, Jimenez D; Air vs Oxygen for Intermediate-Risk Pulmonary Embolism Investigators. Oxygen Therapy in Patients With Intermediate-Risk Acute Pulmonary Embolism: A Randomized Trial. Chest. 2024 Mar;165(3):673-681. doi: 10.1016/j.chest.2023.09.007. Epub 2023 Sep 16. |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| C041364 | nitrox |
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| Galdakao |
| Vizcaya |
| Spain |
| Hospital Clínic de Barcelona | Barcelona | Spain |
| Clínica Universidad de Navarra | Madrid | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | Spain |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |