CoughNCT02269761
Chest Ultrasound of ER Patients With Cough or SOB
An observational study of Cough and Dyspnea, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Nuvis Diagnostic Ultrasound System
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 1 Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency Department (ED) patients with shortness of breath (SOB)
Who may be able to join
- Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath)
- Referred for CXR and/or CT scan
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: Prospective Evaluation With Ultrasound of Emergency Department Patients Presenting With Cough or Dyspnea
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.
Read the detailed description
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. Advantages of ultrasound include real-time immediate evaluation, it is non-invasive and does not use radiation.
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.
- Being tested
- Nuvis Diagnostic Ultrasound System
- Keywords
- Emergency Departments, Chest, Lung, Cough, Dyspnea, Wheezing, Ultrasound, Ultrasonography
- Medical subject headings
- Cough, Dyspnea, Respiratory Sounds, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuvis Diagnostic Ultrasound SystemDevice
Also called Diagnostic ultrasound system and transducers, C5-2 curve linear array USB transducer
Ultrasound of the chest
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startSep 2014
- Primary completion1 Dec 2014
- Study completion1 Jan 2016
Why it stopped: The patients were too sick to consent and we couldn't recruit enough to continue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, Theodore Dubinsky, University of Washington
- Investigators
- Theodore J Dubinsky, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269761
- Sponsor's protocol ID
- 47935
- Status last verified
- Mar 2023
- First submitted
- 3 Oct 2014
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation With Ultrasound of Emergency Department Patients Presenting With Cough or Dyspnea
- ClinicalTrials.gov ID
- NCT02269761
- Acronym / sponsor ID
- 47935
- Keywords
- Emergency Departments, Chest, Lung, Cough, Dyspnea, Wheezing, Ultrasound, Ultrasonography
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The patients were too sick to consent and we couldn't recruit enough to continue the study
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- Sep 2014 (actual)
- Primary completion
- 1 Dec 2014 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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. Advantages of ultrasound include real-time immediate evaluation, it is non-invasive and does not use radiation.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency Department (ED) patients with shortness of breath (SOB)
Key inclusion criteria (2 listed)
- Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath)
- Referred for CXR and/or CT scan
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nuvis Diagnostic Ultrasound SystemAlso: Diagnostic ultrasound system and transducers, C5-2 curve linear array USB transducerUltrasound of the chest | Device | – |
Primary outcome
B-lines on chest ultrasound as a predictor of pulmonary edema and/or pneumonia
Time frame: Up to 1 week
Results from the study ultrasound will be correlated with other imaging results and the emergency physicians initial impression.
Results and safety
The study was stopped early (reason given: The patients were too sick to consent and we couldn't recruit enough to continue the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore J Dubinsky, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough and Dyspnea, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The patients were too sick to consent and we couldn't recruit enough to continue the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
B-lines on chest ultrasound as a predictor of pulmonary edema and/or pneumonia (time frame: Up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.