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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Sponsor:

Information provided by (Responsible Party):

Franciscus Gasthuis

Study Description

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.

Condition or disease	Intervention/treatment
Pulmonary Embolism	Diagnostic Test: Laboratory testing: D-dimeer and astrup

Study Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy Pulmonary Embolism

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Suspected PE Patients with suspected pulmonary embolism	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

Outcome Measures

Primary Outcome Measures :

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 ]

Secondary Outcome Measures :

How many CT-scans would have been avoided if the algorithm was used in normal practice [ Time Frame: At submission in the Emergency Department ]

Eligibility Criteria

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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

Study Population

All patients that present in our emergency department with suspicion of pulmonary embolism

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

Contacts and Locations

Information from the National Library of Medicine

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

Contacts

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Contact: Rick Thissen	+3110 461 6161	r.thissen@franciscus.nl
Contact: Sophie Nieuwendijk

Locations

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Netherlands
Franciscus Gasthuis	Recruiting
Rotterdam, Netherlands
Contact: Sander Mol +31104616161
Principal Investigator: Rick Thissen
Principal Investigator: Sophie Nieuwendijk
Principal Investigator: Renee Deckers

Sponsors and Collaborators

Franciscus Gasthuis

Investigators

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Study Chair:	Sander Mol	Franciscus Gasthuis

More Information

Publications:

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.

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.

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.

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.

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.

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.

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

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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

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Franciscus Gasthuis:


A-a gradient

Additional relevant MeSH terms:

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Pulmonary Embolism Embolism Embolism and Thrombosis Vascular Diseases	Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases

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