An interventional study of Point-of-care-ultrasound examination in Pulmonary Embolism and Pulmonary Embolus/Emboli, sponsored by Odense University Hospital. Completed at 5 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-03.
Sponsored by Odense University Hospital · Not applicable, Interventional, and Diagnostic
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.
All ultrasound examinations will be performed by a physician certified in ultrasound by the Danish Society for Emergency Physicians in accordance with the Danish Health Agency.
Based on ultrasonographic findings, PE suspicion is allocated to one of three categories:
If PE is confirmed by ultrasound, the physician will apply the simplified pulmonary embolism severity index score (sPESI) and estimate risk of mortality within 30 days based on clinical signs and symptoms, cardiac troponin level and RV dysfunction. Patients with intermediate-high or high risk, requiring admission to a cardiology department will be referred for CTPA. Patients with low or intermediate-low risk, not requiring admission, will be discharged with anticoagulative treatment.
A thorough presentation of the sPESI-score and early mortality risk assessment is available in the 2019 collaborative guidelines by the ERS and ESC on the diagnosis and management of PE.
If PE suspicion can be neither dismissed nor confirmed after ultrasound investigation, the patient will be referred to further investigation as usual with CTPA or lung scintigraphy. Subsequent plan will be in accordance with department guidelines.
If PE suspicion is dismissed by ultrasound investigation, the patient will be either discharged or subject to further investigations in accordance with department guidelines if indicated.
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's enrollment of 150 is close to the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
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Exclusion Criteria:
Patients allocated to the PoCUS investigation arm will receive an ultrasound investigation resulting in either confirmation or dismissal of pulmonary embolism suspicion or requiring CTPA or VQ
Diagnostic Test: Point-of-care-ultrasound examination
Patients allocated to the control group will continue with CTPA or VQ without PoCUS investigation
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.
Proportion of patients referred to CTPA or VQ after multiorgan PoCUS
Time frame: Up to 24 hours
Number of adverse events in the intervention and control group after inclusion, including readmission, serious bleeding or death
Time frame: 3 months
Number of hours until initiation of relevant treatment after clinical evaluation in the control and intervention group.
Time frame: Up to 24 hours
Proportion of included patients diagnosed with PE in the control and intervention group
Time frame: Up to 24 hours
Proportion of patients diagnosed with alternative diagnosis following clinical evaluation in the intervention and control group
Time frame: Up to 24 hours
Proportion of patients in the intervention and control group discharged to their own home following clinical evaluation
Time frame: Up to 24 hours
Proportion of patients in the reference and control group admitted to a cardiology department for telemetry monitoring (i.e. high risk PE) following clinical evaluation.
Time frame: Up to 24 hours
Proportion of patients in the reference and control group admitted to an intensive care unit following clinical evaluation
Time frame: Up to 24 hours
Proportion of patients in the reference and control group referred to supplementary CTPA or lung scintigraphy within 30 days after inclusion
Time frame: 30 days
Total costs related to diagnostic work up and hospital stay as assessed by HEAT 4.2
Time frame: Up to 1 year
Number of subsequent cancer diagnosis in the intervention and control group within 3 months of inclusion
Time frame: 3 months
Plan to share: No
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Odense University Hospital