Point-of-care Ultrasound in Suspected Pulmonary Embolism
NCT04882579 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2023-11-03
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
- Pulmonary Embolism
- Pulmonary Embolus/Emboli
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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