Diagnostic Accuracy of Arterial-alveolar Oxygen Gradient in Low Risk Patients With Suspected Pulmonary Embolism (DAGPE)
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ClinicalTrials.gov Identifier: NCT06043726 |
Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
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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.
Condition or disease | Intervention/treatment |
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Pulmonary Embolism | Diagnostic Test: Laboratory testing: D-dimeer and astrup |
Study Type : | Observational |
Estimated Enrollment : | 230 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Diagnostic Accuracy of Arterial-alveolar Oxygen Gradient in Low Risk Patients With Suspected Pulmonary Embolism |
Actual Study Start Date : | September 1, 2022 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | December 31, 2024 |
Group/Cohort | Intervention/treatment |
---|---|
Suspected PE
Patients with suspected pulmonary embolism
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Diagnostic Test: Laboratory testing: D-dimeer and astrup
Standard care: Laboratory result (D-dimer and astrup). CT scan for pulmonary embolism if indicated
Other Name: CT-scan for pulmonary embolism |
- Diagnostic accuracy of a combination of a normal Alveolar-Arterial Oxygen Gradient with negative YEARS criteria in patients with suspected pumonary embolism [ Time Frame: At submission in the Emergency Department ]
- How many CT-scans would have been avoided if the algorithm was used in normal practice [ Time Frame: At submission in the Emergency Department ]
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043726
Contact: Rick Thissen | +3110 461 6161 | r.thissen@franciscus.nl | |
Contact: Sophie Nieuwendijk |
Netherlands | |
Franciscus Gasthuis | Recruiting |
Rotterdam, Netherlands | |
Contact: Sander Mol +31104616161 | |
Principal Investigator: Rick Thissen | |
Principal Investigator: Sophie Nieuwendijk | |
Principal Investigator: Renee Deckers |
Study Chair: | Sander Mol | Franciscus Gasthuis |
Responsible Party: | Franciscus Gasthuis |
ClinicalTrials.gov Identifier: | NCT06043726 |
Other Study ID Numbers: |
2021-040 |
First Posted: | September 21, 2023 Key Record Dates |
Last Update Posted: | September 21, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
A-a gradient |
Pulmonary Embolism Embolism Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |