Diagnosis of Pulmonary Embolism by Doppler Signals

Not Applicable

Terminated

• Conditions: Pulmonary Embolism
• Interventions: Radiation: Diagnostic ultrasound radiation

• Registration Number: NCT02652689
• Lead Sponsor: Echosense Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-12
• Study Start: 2016-04
• Status Verified: 2017-03
• Primary Completion: 2018-12
• Study Completion: 2019-01
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic ultrasound	Diagnostic ultrasound radiation	Recording Doppler ultrasound signals noninvasively from the right chest wall

Primary Outcome Measures

Name	Time	Method
Identify lack of Lung Doppler signals in specific lung sections that were diagnosed obstructed by CT	30min	The obstructed sections will be compared with healthy lung sections

Trial Locations

Locations (1)

Rambam; 🇮🇱 Haifa, Israel