Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
| Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation | OTHER |
| Odense Patient Data Explorative Network | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
1. Clinical suspicion of PE confirmed if ≥1 of the following ultrasound findings:
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.
2. Further diagnostic imaging (CTPA or V/Q) required if ≥1 of the following ultrasound findings:
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.
3. Clinical suspicion of PE dismissed if ≥1 of the following ultrasound findings:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PoCUS group | Experimental | 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 |
|
| Control group | No Intervention | Patients allocated to the control group will continue with CTPA or VQ without PoCUS investigation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-care-ultrasound examination | Diagnostic Test | The intervention consists of three ultrasound modalities:
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients referred to CTPA or VQ after multiorgan PoCUS | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events in the intervention and control group after inclusion, including readmission, serious bleeding or death | 3 months | |
| Number of hours until initiation of relevant treatment after clinical evaluation in the control and intervention group. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Casper Falster, MD | Odense University Hospital | Principal Investigator |
| Christian B Laursen, Prof. MD | Odense University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Esbjerg Hospital | Esbjerg | 6700 | Denmark | |||
| Kolding Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39070742 | Derived | Falster C, Morkenborg MD, Thrane M, Clausen J, Arvig M, Brockhattingen K, Biesenbach P, Paludan L, Nielsen RW, Nhi Huynh TA, Poulsen MK, Brabrand M, Moller JE, Posth S, Laursen CB. Utility of ultrasound in the diagnostic work-up of suspected pulmonary embolism: an open-label multicentre randomized controlled trial (the PRIME study). Lancet Reg Health Eur. 2024 May 28;42:100941. doi: 10.1016/j.lanepe.2024.100941. eCollection 2024 Jul. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D004617 | Embolism |
| D004194 | Disease |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
Not provided
Not provided
150 patients with suspected pulmonary embolism, requiring CTPA or VQ to finally confirm or dismiss the diagnosis will be enrolled and randomized 1:1 to receive a multiorgan ultrasound investigation or continue to CTPA or VQ as planned.
Not provided
Not provided
Not provided
Not provided
|
| Up to 24 hours |
| Proportion of included patients diagnosed with PE in the control and intervention group | Up to 24 hours |
| Proportion of patients diagnosed with alternative diagnosis following clinical evaluation in the intervention and control group | Up to 24 hours |
| Proportion of patients in the intervention and control group discharged to their own home following clinical evaluation | 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. | Up to 24 hours |
| Proportion of patients in the reference and control group admitted to an intensive care unit following clinical evaluation | 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 | 30 days |
| Total costs related to diagnostic work up and hospital stay as assessed by HEAT 4.2 | Up to 1 year |
| Number of subsequent cancer diagnosis in the intervention and control group within 3 months of inclusion | 3 months |
| Kolding |
| 6000 |
| Denmark |
| Odense University Hospital | Odense | 5000 | Denmark |
| Slagelse hospital | Slagelse | 4200 | Denmark |
| Svendborg Hospital | Svendborg | 5700 | Denmark |
| D002318 |
| Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |