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Diagnostic Accuracy of Arterial-alveolar Oxygen Gradient in Low Risk Patients With Suspected Pulmonary Embolism — DAGPE  

Pulmonary Embolism Clinical Trial

Official title:
Diagnostic Accuracy of Arterial-alveolar Oxygen Gradient in Low Risk Patients With Suspected Pulmonary Embolism

Clinical Trial Summary

Introduction: The diagnosis of pulmonary embolism (PE) is a challenge in the Emergency Department. D-dimer based diagnostic algorithms for PE have a very high sensitivity, but rely upon a vast amount of CT angiography and potentially unnecessary exposure to radiation. An accurate diagnostic algorithm that does not involve d-dimer testing might reduce this burden. An abnormal Alveolar-arterial oxygen gradient (A-a gradient) seems to increase the chance of PE. However, a normal A-a gradient on its own does not exclude the diagnosis. In this paper, the accuracy of A-a gradient testing and a combination of Years criteria with A-a gradient testing will be assessed. Methods: This is a prospective, single center, observational study. All patients that present at our emergency department from September 2022 until September 2023 with a suspicion of pulmonary embolism will be analyzed for eligibility and included in the study after informed consent. The aim is to include at least 230 patients in the study. Analysis: The primary outcome is the diagnostic accuracy of a YEARS and A-a gradient based algorithm for pulmonary embolism. The secondary outcome is the potential decrease in performed imaging in order to exclude pulmonary embolism. Valorisation An accurate A-a gradient-based algorithm for pulmonary embolism in low risk patients will be a step towards an improved clinical risk score. We aim to reduce the amount of diagnostic imaging, i.e. CT-angiography. Meaning less, potentially unnecessary, exposure to radiation for the patient. Furthermore, it could lower healthcare costs by reducing expensive diagnostic imaging.

Clinical Trial Description

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Study Design

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Clinical Trial Details
NCT number NCT06043726
Study type Observational
Source Franciscus Gasthuis
Contact Rick Thissen
Phone +3110 461 6161
Email r.thissen@franciscus.nl
Status Recruiting
Phase
Start date September 1, 2022
Completion date December 31, 2024
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