Point-of-care Ultrasound in Suspected Pulmonary Embolism

NCT04882579 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-11-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Point-of-care-ultrasound examination

The intervention consists of three ultrasound modalities: 1. Cardiac ultrasound assessing signs of right ventricular strain or other obvious pathology. 2. Deep venous ultrasound assessing presence of a deep venous thrombus 3. Lung ultrasound assessing presence of pulmonary infarctions, pleural effusion, pneumothorax or interstitial syndrome.

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER
  • Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation

    collaborator OTHER
  • Odense Patient Data Explorative Network

    collaborator OTHER
  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Casper Falster, MD · Odense University Hospital

  • Christian B Laursen, Prof. MD · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2023-02-01
Completion
2023-07-01

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04882579 on ClinicalTrials.gov