Chest Ultrasound of ER Patients With Cough or SOB | NCT02269761

Studies
Chest Ultrasound of ER Patients With Cough or SOB

NCT02269761

Sponsor

University of Washington

Status

Terminated

Last Update Posted

Mar 22, 2023Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Cough
Dyspnea
Wheezing

Interventions

Nuvis Diagnostic Ultrasound System

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The patients were too sick to consent and we couldn't recruit enough to continue the study

Expanded Access Info

Start Date

Sep 2014Actual

Primary Completion Date

Dec 1, 2014Actual

Completion Date

Jan 1, 2016Actual

First Submitted Date

Oct 3, 2014

First Submission Date that Met QC Criteria

Oct 17, 2014

First Posted Date

Oct 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2023

Last Update Posted Date

Mar 22, 2023Actual

Name	Class
Philips Healthcare	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Acute dyspnea (shortness of breath) is a common complaint for patients presenting to the Emergency Department (ED). The chest radiograph (CXR) has been the mainstay in evaluating patients with shortness of breath and often provides the timely diagnosis of pneumonia, pneumothorax, pulmonary edema, among other primary diseases of the lung. There are limitations with chest radiograph such as large body mass (e.g, obesity) and patient positioning. On occasion, chest radiography findings are difficult to interpret. Lung ultrasonography may offer a means of clarifying ambiguous results.

The objective of this study to determine the usefulness of point of care lung ultrasound in evaluating patients presenting to the ED with shortness of breath, cough and/or wheezing.

Detailed Description

The investigators seek to perform a prospective evaluation of patients presenting to the University of Washington Medical Center ED for cough, wheezing and/or shortness of breath.

The objective of this study to determine the usefulness of point of care lung ultrasound in evaluating patients presenting to the ED with shortness of breath, cough and/or wheezing.

The specific aim of this study is to further define the utility of point-of-care ultrasound in the evaluation of emergency department patients presenting with cough, wheezing and/or shortness of breath. The investigators will compare ultrasound results to radiograph and tomography results when available, and to the physicians initial impression.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nuvis Diagnostic Ultrasound System	Device	Ultrasound of the chest		Diagnostic ultrasound system and transducers C5-2 curve linear array USB transducer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
B-lines on chest ultrasound as a predictor of pulmonary edema and/or pneumonia	Results from the study ultrasound will be correlated with other imaging results and the emergency physicians initial impression.	Up to 1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath)
Referred for CXR and/or CT scan

Exclusion Criteria:

Life threatening medical condition requiring immediate treatment
Unable to sit up for a chest ultrasound
Unable to consent
Pregnant
Unable to speak, read and write in English

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Emergency Department (ED) patients with shortness of breath (SOB)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Theodore J Dubinsky, MD	University of Washington	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Washington Medical Center		Seattle	Washington	98195	United States

Condition Browse Module

MeSH Terms

ID	Term
D003371	Cough
D004417	Dyspnea
D012135	Respiratory Sounds
D004630	Emergencies

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014159	Transducers

Ancestor Terms

ID	Term
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided