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

Last updated: September 18, 2023
Sponsor: Franciscus Gasthuis
Overall Status: Active - Recruiting

Phase

N/A

Condition

Claudication

Lung Injury

Thrombosis

Treatment

Laboratory testing: D-dimeer and astrup

Clinical Study ID

NCT06043726
2021-040
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 230
Treatment Group(s): 1
Primary Treatment: Laboratory testing: D-dimeer and astrup
Phase:
Study Start date:
September 01, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Franciscus Gasthuis

    Rotterdam,
    Netherlands

    Active - Recruiting

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