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

Pulmonary Embolism Clinical Trial

— DAGPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06043726
• Other study ID #: 2021-040
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Franciscus Gasthuis
• Contact: Rick Thissen
• Phone: +3110 461 6161
• Email: r.thissen[@]franciscus.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

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

Locations

Country	Name	City	State
Netherlands	Franciscus Gasthuis	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Franciscus Gasthuis

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

Kline JA, Courtney DM, Kabrhel C, Moore CL, Smithline HA, Plewa MC, Richman PB, O'Neil BJ, Nordenholz K. Prospective multicenter evaluation of the pulmonary embolism rule-out criteria. J Thromb Haemost. 2008 May;6(5):772-80. doi: 10.1111/j.1538-7836.2008.02944.x. Epub 2008 Mar 3. — View Citation

Masotti L, Ceccarelli E, Cappelli R, Barabesi L, Forconi S. Arterial blood gas analysis and alveolar-arterial oxygen gradient in diagnosis and prognosis of elderly patients with suspected pulmonary embolism. J Gerontol A Biol Sci Med Sci. 2000 Dec;55(12):M761-4. doi: 10.1093/gerona/55.12.m761. — View Citation

McFarlane MJ, Imperiale TF. Use of the alveolar-arterial oxygen gradient in the diagnosis of pulmonary embolism. Am J Med. 1994 Jan;96(1):57-62. doi: 10.1016/0002-9343(94)90116-3. — View Citation

Overton DT, Bocka JJ. The alveolar-arterial oxygen gradient in patients with documented pulmonary embolism. Arch Intern Med. 1988 Jul;148(7):1617-9. — View Citation

Powrie RO, Larson L, Rosene-Montella K, Abarca M, Barbour L, Trujillo N. Alveolar-arterial oxygen gradient in acute pulmonary embolism in pregnancy. Am J Obstet Gynecol. 1998 Feb;178(2):394-6. doi: 10.1016/s0002-9378(98)80031-8. Erratum In: Am J Obstet Gynecol 1999 Aug;181(2):510. — View Citation

Stein PD, Goldhaber SZ, Henry JW. Alveolar-arterial oxygen gradient in the assessment of acute pulmonary embolism. Chest. 1995 Jan;107(1):139-43. doi: 10.1378/chest.107.1.139. — View Citation

van der Hulle T, Cheung WY, Kooij S, Beenen LFM, van Bemmel T, van Es J, Faber LM, Hazelaar GM, Heringhaus C, Hofstee H, Hovens MMC, Kaasjager KAH, van Klink RCJ, Kruip MJHA, Loeffen RF, Mairuhu ATA, Middeldorp S, Nijkeuter M, van der Pol LM, Schol-Gelok S, Ten Wolde M, Klok FA, Huisman MV; YEARS study group. Simplified diagnostic management of suspected pulmonary embolism (the YEARS study): a prospective, multicentre, cohort study. Lancet. 2017 Jul 15;390(10091):289-297. doi: 10.1016/S0140-6736(17)30885-1. Epub 2017 May 23. Erratum In: Lancet. 2017 Jul 15;390(10091):230. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of a combination of a normal Alveolar-Arterial Oxygen Gradient with negative YEARS criteria in patients with suspected pumonary embolism		At submission in the Emergency Department
Secondary	How many CT-scans would have been avoided if the algorithm was used in normal practice		At submission in the Emergency Department