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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06043726
Acronym
DAGPE
Enrollment
230
Registered
2023-09-21
Start date
2022-09-01
Completion date
2024-12-31
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism

Keywords

A-a gradient

Brief 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.

Interventions

DIAGNOSTIC_TESTLaboratory testing: D-dimeer and astrup

Standard care: Laboratory result (D-dimer and astrup). CT scan for pulmonary embolism if indicated

Sponsors

Franciscus Gasthuis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy of a combination of a normal Alveolar-Arterial Oxygen Gradient with negative YEARS criteria in patients with suspected pumonary embolismAt submission in the Emergency Department

Secondary

MeasureTime frame
How many CT-scans would have been avoided if the algorithm was used in normal practiceAt submission in the Emergency Department

Countries

Netherlands

Contacts

Primary ContactRick Thissen
r.thissen@franciscus.nl+3110 461 6161
Backup ContactSophie Nieuwendijk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026