Evaluating the accuracy of oxygen gradient tests for diagnosing pulmonary embolism
Diagnostic Accuracy of Arterial-alveolar Oxygen Gradient in Low Risk Patients With Suspected Pulmonary Embolism
This study is testing if a new oxygen test can help doctors more accurately diagnose pulmonary embolism in patients who come to the emergency room.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 230 (estimated) |
| Sex | All |
| Sponsor | Franciscus Gasthuis Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT06043726 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic accuracy of the arterial-alveolar oxygen gradient in patients suspected of having pulmonary embolism (PE) in the emergency department. It will analyze patients presenting with PE suspicion from September 2022 to September 2023, focusing on the relationship between the A-a gradient and PE diagnosis. The study will include at least 230 patients and will evaluate the effectiveness of combining A-a gradient testing with the YEARS criteria. The goal is to provide a more accurate diagnostic algorithm that reduces reliance on D-dimer testing and CT angiography.
Who should consider this trial
Good fit: Ideal candidates are patients presenting to the emergency department with suspected pulmonary embolism and available D-dimer and arterial blood gas results.
Not a fit: Patients who are pregnant or lack sufficient data for the YEARS criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more accurate and less invasive method for diagnosing pulmonary embolism.
How similar studies have performed: While the approach of using A-a gradient testing is not widely established, similar studies have explored alternative diagnostic methods for PE, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rotterdam
- Franciscus Gasthuis — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Rick Thissen
- Email: r.thissen@franciscus.nl
- Phone: +3110 461 6161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.