NCT04882579

Point-of-care Ultrasound in Suspected Pulmonary Embolism

Completed NA Last updated 3 November 2023

What this trial tests

NA trial testing Point-of-care-ultrasound examination in Pulmonary Embolism in 150 participants. Completed in 1 July 2023.

Timeline

15 June 2021

Primary endpoint
1 February 2023

1 July 2023

Quick facts

Lead sponsor	Odense University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	150
Start date	15 June 2021
Primary completion	1 February 2023
Estimated completion	1 July 2023
Sites	5 locations across Denmark

Drugs / interventions tested

• Point-of-care-ultrasound examination

Conditions studied

• Pulmonary Embolism — all drugs for Pulmonary Embolism →
• Pulmonary Embolus/Emboli — all drugs for Pulmonary Embolus/Emboli →

Sponsor

Odense University Hospital

Who can join

18 and older, any sex, with Pulmonary Embolism or Pulmonary Embolus/Emboli. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pulmonary embolism (PE) is a common cardiovascular condition with an estimated incidence of 0.60 to 1.12 per 1000 inhabitants in the United States of America, and the diagnosis is challenging as patients with PE present with a wide array of symptoms.

Computed tomography pulmonary angriography (CTPA) and lung ventilation-perfusion scintigraphy (VQ) are considered the gold-standards in PE-diagnostics but may not always be feasible. CTPA is contraindicated by contrast allergy or renal failure and both modalities require involvement of multiple staff-members and transport of the patient. Lung scintigraphy cannot be performed in an emergency situation, with unstable patients and patients unable to comply to the examination.

Ultrasound represent a possible tool in confirming or dismissing clinical PE suspicion. Ultrasound is non-invasive and can be performed bedside by the clinician, an approach known as point-of-care ultrasound (PoCUS), reducing both time, radiation-exposure and costs.

The aim of this study is to investigate whether integrating cardiac, lung and deep venous ultrasound in the clinical evaluation of suspected PE reduces the need for referral to CTPA or lung scintigraphy, during emergency department work up, while maintaining safety standards.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Utility of ultrasound in the diagnostic work-up of suspected pulmonary embolism: an open-label multicentre randomized controlled trial (the PRIME study).
   Falster C, Mørkenborg MD, Thrane M, Clausen J, et al · · 2024 · cited 8× · PMID 39070742 · DOI 10.1016/j.lanepe.2024.100941