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

F

Franciscus Gasthuis

Status

Enrolling

Conditions

Pulmonary Embolism

Treatments

Diagnostic Test: Laboratory testing: D-dimeer and astrup

Study type

Observational

Funder types

Other

Identifiers

NCT06043726
2021-040

Details and patient eligibility

About

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.

Enrollment

230 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient with suspected pulmonary embolism
  • Emergency department D-dimer result available
  • Arterial blood gas available

Exclusion criteria

  • Patients without documented oxygen suppletion durig blood gas measurement
  • Patients without documented and insufficient data to calculate YEARS criteria
  • Pregnancy

Trial design

230 participants in 1 patient group

Suspected PE
Description:
Patients with suspected pulmonary embolism
Treatment:
Diagnostic Test: Laboratory testing: D-dimeer and astrup

Trial contacts and locations

1

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Central trial contact

Sophie Nieuwendijk; Rick Thissen

Data sourced from clinicaltrials.gov

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