Accuracy of Multi-organ Ultrasound for the Diagnosis of Pulmonary Embolism

Accuracy of Multi-organ Ultrasound (Venous, Cardiac and Thoracic) for the Diagnosis of Pulmonary Embolism: Suspected Pulmonary Embolism Sonographic Assessment (SPES) Multicenter Prospective Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01635257

Acronym

SPES

Enrollment

357

Registered

2012-07-09

Start date

2012-06-30

Completion date

2012-12-31

Last updated

2013-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism

Keywords

pulmonary embolism diagnosis, ultrasound

Brief summary

Patients with suspected Pulmonary Embolism (PE) and a high clinical probability or a high D-dimer level should undergo a second level diagnostic test such as Multidetector Computed Tomography Angiography (MCTPA). Unfortunately MCTPA involves radiation exposure, is expensive, is not feasible in unstable patients and has contraindications. UltraSound (US) is safe and rapidly available even in unstable patients. Many authors evaluated the diagnostic role of Compression Ultrasound Scan (CUS) for detecting limbs Deep Vein Thrombosis (DVT), TransThoracic Echocardiography (TTE) for detecting Right Ventricular Dysfunction (RVD) or Thoracic UltraSound (TUS) for detecting subpleural infarcts in patients with suspected PE. No previous studies have investigated the diagnostic accuracy of CUS, TTE and TUS combined (multiorgan US) for the diagnosis of PE. This study evaluates the diagnostic accuracy of multiorgan US. Methods. Consecutive patients that underwent MCTPA in the Emergency Department for clinical suspicion of PE and with a simplified Well's score\>4 (PE likely) or with a D-dimer value ≥500ng/ml were enrolled in the study. MCTPA was considered the gold standard for PE diagnosis. A multiorgan US was performed by an emergency physician sonographer before MCTPA. PE was considered echographically present if CUS was positive for DVT or TTE was positive for RVD or at least one pulmonary subpleural infarct was detected with TUS. The accuracy of the single and multiorgan US was calculated.

Interventions

OTHERUltrasound scan

A multiorgan ultrasound was performed by an emergency physician sonographer before MCTPA. Pulmonary embolism was considered echographically present if compression ultrasound was positive for deep vein thrombosis or transthoracic-echocardiography was positive for right ventricular dysfunction or at least one pulmonary subpleural infarct was detected with thoracic ultrasound.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Patients with clinical suspected pulmonary embolism * Simplified Well's score\>4 (PE likely) or D-dimer value ≥500ng/ml * Patients that undergo MCTPA in the Emergency Department for suspected pulmonary embolism

Exclusion criteria

* Refused consent * Less than 18 years old * Not possible to perform ultrasound scan within 3 hours before MCTPA

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of ultrasound for the diagnosis of pulmonary embolism	The goldstandard for PE diagnosis is the MCTPA performed within 24 hours from ED presentation. The recruiting period is 5 months. There is not a follow-up for the included patients.	Sensitivity, specificity, negative and positive predictive value, negative and positive likelihood ratio of limb, cardiac, thoracic and multi-organ ultrasound for the diagnosis of pulmonary embolism in the emergency department considering as gold standard the Multidetector Computed Tomography Angiography (MCTPA)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026