NCT02248831

Brief Summary

Historically, ultrasound imaging of the lung parenchyma has been challenging because of the high total ultrasound energy attenuation and scattering by the air in the lungs. However, recent technological advancements have allowed for rapid assessment of various pulmonary diseases via the use of lung ultrasound. Furthermore, it has been shown that clear reproducible Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal-processing package. 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 a pilot clinical validation study of patients with acute decompensated heart failure (ADHF) patients, LDS signals unique to ADHF patients were identified, that superpose on the normal Lung Doppler Signals (unpublished data). These are high velocity "disorganized" variable signals that are not synchronous with the cardiac cycle but rather sometimes with respiration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 8, 2019

Status Verified

November 1, 2016

Enrollment Period

3.7 years

First QC Date

September 18, 2014

Last Update Submit

February 7, 2019

Conditions

DyspneaAcute Decompensated Heart Failure

Keywords

DyspneaAcute decompensated heart failureDoppler ultrasoundLung Doppler signals

Outcome Measures

Primary Outcomes (1)

  • Number of patients identified with COPD (or CHF) in comparison to physician diagnosis

    1y

Secondary Outcomes (1)

  • Identify changes in lung doppler signals according to the clinical status over few days in comparison to the physician diagnosis

    1y

Study Arms (1)

Doppler ultrasound

EXPERIMENTAL

Using ultrasound noninvasively and recording Doppler signals from the right chest wall

Device: Recording Doppler ultrasound signals noninvasively

Interventions

Recording Doppler ultrasound signals noninvasivelyDEVICE

Using ultrasound noninvasively and recording Doppler signals from the right chest wall

Doppler ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Phase 1(ED):
  • Age \> 18 years Acute onset dyspnea
  • Phase 2 (Inpatient):
  • Age \> 18 years Acute onset dyspnea: defined as SOB at rest or with minimal activity, with onset within the past 14 days PLUS
  • The following criteria are required to be classified as heart failure (event has to meet all of the following criteria):
  • a) The patient exhibits documented new or worsening symptoms due to heart failure on presentation, including at least one of the following: i) Dyspnea (dyspnea with exertion, dyspnea at rest, orthopnea) ii) Decreased exercise tolerance b) The patient has objective evidence of new or worsening heart failure, consisting of at least two physical exam findings (or one physical exam finding and one diagnostic criterion) including: i) Physical exam findings considered to be due to heart failure, including new or worsened:
  • (1) Peripheral edema (2) Increasing abdominal distention or ascites (in the absence of primary hepatic disease) (3) Increased jugular venous pressure and/or hepatojugular reflux (4) Rapid weight gain thought to be related to fluid overload ii) Diagnostic findings considered to be due to heart failure, including new or worsened:
  • Increased B-type natriuretic peptide/ NT-proBNP concentrations consistent with decompensation of heart failure Note: In patients with chronically elevated natriuretic peptides, a significant increase should be noted above baseline.
  • Radiological evidence of pulmonary congestion

You may not qualify if:

  • Phase 1 (ED):
  • Pregnant women Inability to consent
  • Phase 2 (Inpatient):
  • Pregnant women Pneumonia - currently, or within the past 30 days Non-cardiogenic pulmonary edema (e.g. ARDS) Interstitial lung disease Inability to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Medicine department and Inpatients floors,MGH

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maulik Majmudar, Dr

    MGH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2014

First Posted

September 25, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2018

Study Completion

December 1, 2018

Last Updated

February 8, 2019

Record last verified: 2016-11

Locations

US(1)