Diagnosis of Pulmonary Embolism by Doppler Signals

Echosense

Status: Terminated

Conditions: Pulmonary Embolism

Treatments: Radiation: Diagnostic ultrasound radiation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02652689

DOP023

Details and patient eligibility

About

The LDS may contain information of significant diagnostic and physiological value regarding the pulmonary parenchyma and vasculature, as well as the cardio- vascular system in general. In pilot clinical studies of patients with acute decompensated heart failure (ADHF) as well as patients with Pulmonary Hypertension, LDS signals patterns unique to these conditions were identified. We believe that these newly discovered ultrasound signals might provide a non-invasive radiation-free means to diagnose and monitor patients with Pulmonary Embolism.

The purpose of this study is to assess the utility of noninvasive assessment of lung Doppler signals performed via transthoracic parametric Doppler. The objective of the study is to evaluate the lung Doppler signals (LDS) in patients diagnosed with acute PE, in order to determine the potential assessment value of this non-invasive method in this potentially life threatening condition.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of acute PE on CTA

Exclusion criteria

• Pregnant women
• Inability to consent
• Patients with severe chest wall deformity
• Previously diagnosed PE
• Pneumonia
• Pulmonary edema
• Pneumothorax
• Severe COPD (gold class III, IV)
• Hemodynamically unstable patients

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Diagnostic ultrasound

Experimental group

Description:

Recording Doppler ultrasound signals noninvasively from the right chest wall

Treatment:

Radiation: Diagnostic ultrasound radiation