This clinical trial is focused on studying the effects of using oxygen as a treatment for patients with acute pulmonary embolism. Acute pulmonary embolism is a condition where one or more arteries in the lungs become blocked by a blood clot. The trial aims to determine how effective supplemental oxygen is for patients who are at intermediate risk due to this condition.
The study will involve patients who have been diagnosed with acute pulmonary embolism and will assess the role of oxygen over a period of 30 days. Participants will receive oxygen through inhalation, which means breathing in the oxygen gas. The trial will compare the outcomes of those receiving oxygen with those who do not, to see if oxygen helps improve their condition.
The main goal of the study is to evaluate whether using oxygen can prevent serious complications such as hemodynamic collapse, which is a severe drop in blood pressure, or death within 30 days. The study will also look at other factors like the length of hospital stay and any serious side effects. The results will help understand if oxygen is beneficial for patients with acute pulmonary embolism.
1enrollment
Enrollment in the study occurs after confirmation of pulmonary embolism through a specific type of imaging called multidetector computed tomographic pulmonary angiography.
Additionally, right ventricular enlargement must be confirmed by either computed tomography or echocardiography, with a right ventricle/left ventricle ratio greater than 1.0.
2treatment initiation
Upon enrollment, the treatment phase begins. The main focus is on evaluating the effectiveness of supplemental oxygen in patients with intermediate-risk acute pulmonary embolism.
Oxygen is administered as an inhalation gas. The specific dosage and frequency are determined by the study protocol and the healthcare team.
3monitoring and follow-up
Throughout the study, monitoring is conducted to assess the primary endpoint, which is a combination of hemodynamic collapse or death from any cause within 30 days after enrollment.
Secondary endpoints include various outcomes such as death from any cause, hemodynamic collapse, pulmonary embolism-related mortality, length of hospital stay, serious adverse events, major bleeding, and recurrent symptomatic venous thromboembolism, all within specified timeframes.
4completion
The study is designed to conclude with an evaluation of the collected data to determine the role of oxygen in the treatment of acute pulmonary embolism.
The estimated end date for the trial is August 1, 2028.
Who Can Join the Study?
The patient must have a pulmonary embolism. This is a condition where a blood clot blocks blood flow in the lungs. It must be confirmed by a special type of scan called multidetector computed tomographic pulmonary angiography.
The patient must have right ventricular enlargement. This means the right side of the heart is larger than normal. It should be confirmed by a computed tomography scan or an echocardiography test, which are imaging tests that show the heart’s structure. The right side of the heart should be larger than the left side, with a ratio greater than 1.0.
The patient must be within a certain age range, specifically between 18 and 64 years old.
Both male and female patients can participate.
The patient should not be part of a vulnerable population, meaning they should not be in a group that needs special protection or care.
Who Cannot Join the Study?
Patients who are not diagnosed with Acute Pulmonary Embolism. This is a condition where a blood clot blocks blood flow to the lungs.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.
Oxygen is being studied in this trial to see if it helps patients with intermediate-risk acute pulmonary embolism. The trial aims to determine if providing extra oxygen can improve the condition of these patients by day 30. Oxygen is often used to help people breathe better and ensure that their body gets enough oxygen, especially when their lungs are not working well.
Acute Pulmonary Embolism – This condition occurs when a blood clot blocks one or more arteries in the lungs, often originating from clots in the legs. It can cause sudden shortness of breath, chest pain, and a rapid heart rate. As the condition progresses, it may lead to decreased oxygen levels in the blood and strain on the heart. The severity of symptoms can vary depending on the size and number of clots. In some cases, it can cause fainting or a feeling of impending doom. The condition requires prompt medical attention to prevent complications.
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