Diagnosis of Pulmonary Embolism by Doppler Signals

Pulmonary Embolism Clinical Trial

Official title:

Transthoracic Parametric Doppler Assessment of Lung Doppler Signals in Acute Pulmonary Embolism

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02652689
• Other study ID #: DOP023
• Status: Terminated
• Phase: N/A
• Start date: April 2016
• Est. completion date: January 2019

Study information

• Verified date: March 2017
• Source: Echosense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Radiation:
• Diagnostic ultrasound radiation
Recording Doppler ultrasound signals from the right chest wall

Locations

Country	Name	City	State
Israel	Rambam	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Echosense Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify lack of Lung Doppler signals in specific lung sections that were diagnosed obstructed by CT	The obstructed sections will be compared with healthy lung sections	30min