Point-of-care Ultrasound in Suspected Pulmonary Embolism

NCT ID: NCT04882579

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2023-07-01

Brief 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.

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:

1. Clinical suspicion of PE confirmed if ≥1 of the following ultrasound findings:

1. Visible proximal deep venous thrombus

2. ≥2 hypoechoic subpleural lung consolidations with a diameter of ≥0,5cm

3. Visible right ventricular thrombus

4. McConnell's sign if no known pulmonary hypertension, interstitial lung disease, COPD or pulmonary valve disease

5. 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.

2. Further diagnostic imaging (CTPA or V/Q) required if ≥1 of the following ultrasound findings:

1. 1 hypoechoic subpleural lung consolidation with a diameter of ≥0,5cm

2. Pleural effusion not explained by other cause

3. Basal RVEDD/LVEDD >1.0 or an RV visibly larger than the LV

4. TAPSE <17 mm

5. No deep venous thrombus, no lung consolidation or effusion, no signs of RV strain or thrombus but strong clinical suspicion.

6. 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.

3. Clinical suspicion of PE dismissed if ≥1 of the following ultrasound findings:

1. 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

2. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PoCUS group

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

Group Type: EXPERIMENTAL

Point-of-care-ultrasound examination

Intervention Type: DIAGNOSTIC_TEST

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.

Control group

Patients allocated to the control group will continue with CTPA or VQ without PoCUS investigation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation

OTHER

Sponsor Role: collaborator

Odense Patient Data Explorative Network

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Casper Falster

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Casper Falster, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Christian B Laursen, Prof. MD

Role: STUDY_CHAIR

Odense University Hospital

Locations

Esbjerg Hospital

Esbjerg, , Denmark

Kolding Hospital

Kolding, , Denmark

Odense University Hospital

Odense, , Denmark

Slagelse hospital

Slagelse, , Denmark

Svendborg Hospital

Svendborg, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 39070742 (View on PubMed)

Other Identifiers

PulmonaryEmbolismPoCUSOdense

Identifier Type: -

Identifier Source: org_study_id