Pulmonary EmbolismNCT04882579
Point-of-care Ultrasound in Suspected Pulmonary Embolism
A study testing Point-of-care-ultrasound examination in people with Pulmonary Embolism and Pulmonary Embolus/Emboli, run by Odense University Hospital at 5 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Pulmonary Embolus/Emboli
- What is being tested?
- Point-of-care-ultrasound examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesDenmark
- Study dates
- 15 Jun 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred or Admitted to an emergency department
- Clinical suspicion of PE raised by physician requiring further diagnostic imaging (Well's score 0-6 with elevated age-adjusted D-dimer or Wells score >6 regardless of D-dimer)
Who cannot join
- Refusal of informed consent
- Pregnancy
- Permanent mental disability
- Age <18 years
- Diagnosis of PE within the last 6 months
- Hemodynamic instability (systolic blood pressure <90 mmHg for at least two consecutive measurements)
- Ultrasound of heart, lungs or deep veins performed prior to enrollment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Esbjerg Hospital
Esbjerg, 6700
Kolding Hospital
Kolding, 6000
Odense University Hospital
Odense, 5000
Slagelse hospital
Slagelse, 4200
Svendborg Hospital
Svendborg, 5700
About this study
Official title: Point-of-care Ultrasound in the Diagnostic Work-up of Suspected Pulmonary Embolism - a Multicenter Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
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:
- Clinical suspicion of PE confirmed if ≥1 of the following ultrasound findings:
- Visible proximal deep venous thrombus
- ≥2 hypoechoic subpleural lung consolidations with a diameter of ≥0,5cm
- Visible right ventricular thrombus
- McConnell's sign if no known pulmonary hypertension, interstitial lung disease, COPD or pulmonary valve disease
- D-sign present in both systole and diastole if no known pulmonary hypertension, interstitial lung disease, COPD or pulmonary valve disease
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.
- Further diagnostic imaging (CTPA or V/Q) required if ≥1 of the following ultrasound findings:
- 1 hypoechoic subpleural lung consolidation with a diameter of ≥0,5cm
- Pleural effusion not explained by other cause
- Basal RVEDD/LVEDD >1.0 or an RV visibly larger than the LV
- TAPSE <17 mm
- No deep venous thrombus, no lung consolidation or effusion, no signs of RV strain or thrombus but strong clinical suspicion.
- McConnell's or D-sign in the presence of known pulmonary hypertension, interstitial lung disease, COPD or pulmonary valve disease
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.
- Clinical suspicion of PE dismissed if ≥1 of the following ultrasound findings:
- No deep venous thrombus, no lung consolidation or effusion, no signs of RV strain or thrombus and a plausible differential diagnosis or low clinical suspicion
- Obvious differential diagnosis demonstrated on ultrasound (i.e., pneumonia, pneumothorax, interstitial syndrome, left sided heart failure)
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.
- Conditions
- Pulmonary Embolism, Pulmonary Embolus/Emboli
- Being tested
- Point-of-care-ultrasound examination
- Keywords
- Ultrasound, Diagnosis, Ultrasonography, Echocardiography
- Medical subject headings
- Pulmonary Embolism, Embolism, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care-ultrasound examinationDiagnostic test
The intervention consists of three ultrasound modalities:
- Cardiac ultrasound assessing signs of right ventricular strain or other obvious pathology.
- Deep venous ultrasound assessing presence of a deep venous thrombus
- Lung ultrasound assessing presence of pulmonary infarctions, pleural effusion, pneumothorax or interstitial syndrome.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Point-of-care-ultrasound examination |
| Control group | No intervention | Patients allocated to the control group will continue with CTPA or VQ without PoCUS investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients referred to CTPA or VQ after multiorgan PoCUS
Measured: Up to 24 hours
Secondary outcomes (10)
Number of adverse events in the intervention and control group after inclusion, including readmission, serious bleeding or death
Measured: 3 months
Number of hours until initiation of relevant treatment after clinical evaluation in the control and intervention group.
Measured: Up to 24 hours
Proportion of included patients diagnosed with PE in the control and intervention group
Measured: Up to 24 hours
Proportion of patients diagnosed with alternative diagnosis following clinical evaluation in the intervention and control group
Measured: Up to 24 hours
Proportion of patients in the intervention and control group discharged to their own home following clinical evaluation
Measured: 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.
Measured: Up to 24 hours
Proportion of patients in the reference and control group admitted to an intensive care unit following clinical evaluation
Measured: 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
Measured: 30 days
Total costs related to diagnostic work up and hospital stay as assessed by HEAT 4.2
Measured: Up to 1 year
Number of subsequent cancer diagnosis in the intervention and control group within 3 months of inclusion
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start15 Jun 2021
- Primary completion1 Feb 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation, Odense Patient Data Explorative Network
- Responsible party
- Principal investigator, Casper Falster, Odense University Hospital
- Investigators
- Casper Falster, MD, Principal investigator, Odense University HospitalChristian B Laursen, Prof. MD, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882579
- Sponsor's protocol ID
- PulmonaryEmbolismPoCUSOdense
- Status last verified
- Nov 2023
- First submitted
- 12 Apr 2021
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39070742
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-care Ultrasound in the Diagnostic Work-up of Suspected Pulmonary Embolism - a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04882579
- Acronym / sponsor ID
- PulmonaryEmbolismPoCUSOdense
- Conditions
- Pulmonary Embolism, Pulmonary Embolus/Emboli
- Keywords
- Ultrasound, Diagnosis, Ultrasonography, Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation, Odense Patient Data Explorative Network
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Clinical suspicion of PE confirmed if ≥1 of the following ultrasound findings:
- Visible proximal deep venous thrombus
- ≥2 hypoechoic subpleural lung consolidations with a diameter of ≥0,5cm
- Visible right ventricular thrombus
- McConnell's sign if no known pulmonary hypertension, interstitial lung disease, COPD or pulmonary valve disease
- D-sign present in both systole and diastole if no known pulmonary hypertension, interstitial lung disease, COPD or pulmonary valve disease
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.
- Further diagnostic imaging (CTPA or V/Q) required if ≥1 of the following ultrasound findings:
- 1 hypoechoic subpleural lung consolidation with a diameter of ≥0,5cm
- Pleural effusion not explained by other cause
- Basal RVEDD/LVEDD >1.0 or an RV visibly larger than the LV
- TAPSE <17 mm
- No deep venous thrombus, no lung consolidation or effusion, no signs of RV strain or thrombus but strong clinical suspicion.
- McConnell's or D-sign in the presence of known pulmonary hypertension, interstitial lung disease, COPD or pulmonary valve disease
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.
- Clinical suspicion of PE dismissed if ≥1 of the following ultrasound findings:
- No deep venous thrombus, no lung consolidation or effusion, no signs of RV strain or thrombus and a plausible differential diagnosis or low clinical suspicion
- Obvious differential diagnosis demonstrated on ultrasound (i.e., pneumonia, pneumothorax, interstitial syndrome, left sided heart failure)
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PoCUS group | Experimental | Diagnostic Test: Point-of-care-ultrasound examinationPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Referred or Admitted to an emergency department
- Clinical suspicion of PE raised by physician requiring further diagnostic imaging (Well's score 0-6 with elevated age-adjusted D-dimer or Wells score >6 regardless of D-dimer)
Key exclusion criteria (7 listed)
- Refusal of informed consent
- Pregnancy
- Permanent mental disability
- Age <18 years
- Diagnosis of PE within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care-ultrasound examinationThe 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. | Diagnostic test | PoCUS group |
Primary outcome
Proportion of patients referred to CTPA or VQ after multiorgan PoCUS
Time frame: Up to 24 hours
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Derived from this study: PubMed 39070742Falster 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Casper Falster, MD principal investigator
Odense University Hospital
Christian B Laursen, Prof. MD study chair
Odense University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care-ultrasound examination in people with Pulmonary Embolism and Pulmonary Embolus/Emboli, run by Odense University Hospital at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients referred to CTPA or VQ after multiorgan PoCUS (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04882579, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.