Skip to main content
OpenTrials
Completed

NCT Number: NCT04882579

Point-of-care Ultrasound in Suspected Pulmonary Embolism

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Esbjerg Hospital, Esbjerg, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Point-of-care-ultrasound examination

Diagnostic 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.

Primary outcomes

  1. Proportion of patients referred to CTPA or VQ after multiorgan PoCUS

    Time frame: Up to 24 hours

Secondary outcomes

  1. Number of adverse events in the intervention and control group after inclusion, including readmission, serious bleeding or death

    Time frame: 3 months

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

    Time frame: Up to 24 hours

  3. Proportion of included patients diagnosed with PE in the control and intervention group

    Time frame: Up to 24 hours

  4. Proportion of patients diagnosed with alternative diagnosis following clinical evaluation in the intervention and control group

    Time frame: Up to 24 hours

  5. Proportion of patients in the intervention and control group discharged to their own home following clinical evaluation

    Time frame: Up to 24 hours

  6. 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

  7. Proportion of patients in the reference and control group admitted to an intensive care unit following clinical evaluation

    Time frame: Up to 24 hours

  8. 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

  9. Total costs related to diagnostic work up and hospital stay as assessed by HEAT 4.2

    Time frame: Up to 1 year

  10. Number of subsequent cancer diagnosis in the intervention and control group within 3 months of inclusion

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

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

Registry information

Official study title

Point-of-care Ultrasound in the Diagnostic Work-up of Suspected Pulmonary Embolism - a Multicenter Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 12, 2021
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.