Point-of-care Ultrasound in Suspected Pulmonary Embolism

NCT04882579 | Completed DMC

• 1 other identifier: PulmonaryEmbolismPoCUSOdense
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

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.

Conditions

Pulmonary Embolism; Pulmonary Embolus/Emboli

Keywords

Ultrasound; Diagnosis; Ultrasonography; Echocardiography

Outcome Measures

Primary Outcomes (1)

• Proportion of patients referred to CTPA or VQ after multiorgan PoCUS

  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

  3 months

• Number of hours until initiation of relevant treatment after clinical evaluation in the control and intervention group.

  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

Study Arms (2)

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

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

Interventions

Point-of-care-ultrasound examination 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.

PoCUS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator
• Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation: collaborator
• Odense Patient Data Explorative Network: collaborator

Study Sites (5)

Esbjerg Hospital

Esbjerg, 6700, Denmark

Location

Kolding Hospital

Kolding, 6000, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Slagelse hospital

Slagelse, 4200, Denmark

Location

Svendborg Hospital

Svendborg, 5700, Denmark

Location

Related Publications (1)

• 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.

  PMID: 39070742 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism; Embolism; Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Casper Falster, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Christian B Laursen, Prof. MD

  Odense University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: May 12, 2021
• Study Start: June 15, 2021
• Primary Completion: February 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)