Chest PainNCT02861508
Impact of Immediate Point-of-Care Ultrasound on Patients With Cardiopulmonary Symptoms in the Emergency Department
A study testing Point-of-care ultrasound in people with Chest Pain and Dyspnea, run by Yale University at 1 site in United States.
Trial summary
The purpose of the proposed research is to examine whether incorporating point-of-care ultrasound (POCUS) early in diagnostic work-up of cardiopulmonary complaints will affect diagnosis, time to condition-specific intervention, and ultimately patient outcomes compared to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain, Dyspnea, Syncope
- What is being tested?
- Point-of-care ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 30 Jun 2018
- Phase
- Interventional
- 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
Who may be able to join
- Chief complaint of chest pain, dyspnea (either sudden onset or increased severity of chronic dyspnea), syncope, or hypotension (systolic blood pressure <100 or shock index [heart rate divided by systolic blood pressure] >1)
Who cannot join
- <18 years old
- Prisoner or ward of the state
- Trauma
- High acuity requiring treatment in resuscitation room
- Obvious cause of symptoms (e.g. acute GI bleed causing hypotension)
- Any form of "do not resuscitate" (DNR) order
- Roomed in hall of emergency department (location not amenable to ultrasound protocol)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
The purpose of the proposed research is to examine whether incorporating point-of-care ultrasound (POCUS) early in diagnostic work-up of cardiopulmonary complaints will affect diagnosis, time to condition-specific intervention, and ultimately patient outcomes compared to usual care.
- Conditions
- Chest Pain, Dyspnea, Syncope, Hypotension
- Being tested
- Point-of-care ultrasound, Usual care
- Keywords
- Ultrasonography
- Medical subject headings
- Chest Pain, Dyspnea, Syncope, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care ultrasoundOther
Usual careOther
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Usual care as determined by treating team. Ultrasound may still be part of the workup per the treating team's discretion. Receives: Other: Usual care |
| Early POCUS | Experimental | Point-of-care ultrasound protocol will involve cardiac views (for pericardial effusion, left ventricular function, left and right ventricular equality, aortic root dilation, and inferior vena cava status), lung views (for pneumothorax, signs of alveolar interstitial syndrome), abdominal views for free fluid, and a view of the abdominal aorta for aneurysm. Receives: Other: Point-of-care ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to appropriate intervention
Based on final diagnosis as determined by final review of the patient's overall visit in the medical record, it will be determined what the appropriate intervention(s) that the patient should have received. Subsequently, the amount of time that elapsed (minutes) between time the patient was roomed in the emergency department (ED) and time to when they received the intervention will be collected. All these time points are readily available in the electronic medical record in the patient care timeline. This outcome will help determine whether early POCUS affects how quickly patients receive appropriate intervention.
Measured: Within 30 days of presentation
Secondary outcomes (6)
Diagnostic accuracy
The treating team in the ED will be asked for their diagnostic impression of the patient's chief complaint at several points during the patient's time in the ED. These points will be (1) after the primary provider's initial assessment, (2) at time of disposition, and (3) if they are in the early POCUS group, after the POCUS findings are relayed to them. They will select their single most likely diagnosis each time, which will be compared against a final diagnosis as determined by final review of the patient's overall visit in the medical record (as this study's gold standard for diagnosis). This outcome will examine how often (percentage-wise) the treating team's diagnosis matches the final diagnosis as well as if early POCUS has any impact on helping physicians reach the correct diagnosis.
Measured: Within 30 days of presentation
Diagnostic certainty
Similar to the outcome of diagnostic accuracy, the treating team in the ED will concomitantly be asked how certain they feel about their diagnosis on a five-point scale. The presence of any changes in certainty (i.e. proportion of patients for whom certainty changed) as well as how much change (e.g. increased certainty by 2 points) will be assessed. This outcome will determine if early POCUS affects physicians' certainty of diagnosis.
Measured: Within 2 days of presentation
Time to disposition
This will be measured as amount of time (in minutes) that elapse between the time patient is roomed in the ED to time the treating team determines patient disposition. These timestamps are available in the medical record under the patient care timeline. This outcome will examine if early POCUS affects the time it takes for the treatment team to achieve a disposition plan for the patient.
Measured: Within 2 days of presentation
Total length of stay
This will be measured as time (in days) between the patient's date of presentation and date of discharge. This outcome will examine if early POCUS affects the amount of time that patients stay in the hospital.
Measured: Within 30 days of presentation
30-day in-hospital mortality
Patients will be followed in their medical record for up to 30 days after their initial presentation to assess for in-hospital mortality rate. This outcome will examine if early POCUS leads to any significant difference in patient mortality rate compared to usual care.
Measured: Within 30 days of presentation
Duration of POCUS
For the early POCUS group, this will be measured as the amount of time (in minutes) between the time the ultrasound is started and the time the last image is captured. All images/video clips acquired by the ultrasound machine have a timestamp. A blank image will be captured at the start of the exam for the initial timestamp. This outcome will examine how time-consuming our POCUS exam is and provides a sense of how disruptive the introduction of POCUS might be if it were implemented routinely.
Measured: Within 2 days of presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start1 Jul 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Moore, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861508
- Sponsor's protocol ID
- 1605017729
- Status last verified
- Feb 2020
- First submitted
- 5 Aug 2016
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No specific plans for now but would be open to sharing anonymized data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Immediate Point-of-Care Ultrasound on Patients With Cardiopulmonary Symptoms in the Emergency Department
- ClinicalTrials.gov ID
- NCT02861508
- Acronym / sponsor ID
- 1605017729
- Conditions
- Chest Pain, Dyspnea, Syncope, Hypotension
- Keywords
- Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 10 Aug 2016 (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.
The purpose of the proposed research is to examine whether incorporating point-of-care ultrasound (POCUS) early in diagnostic work-up of cardiopulmonary complaints will affect diagnosis, time to condition-specific intervention, and ultimately patient outcomes compared to usual care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual careUsual care as determined by treating team. Ultrasound may still be part of the workup per the treating team's discretion. |
| Early POCUS | Experimental | Other: Point-of-care ultrasoundPoint-of-care ultrasound protocol will involve cardiac views (for pericardial effusion, left ventricular function, left and right ventricular equality, aortic root dilation, and inferior vena cava status), lung views (for pneumothorax, signs of alveolar interstitial syndrome), abdominal views for free fluid, and a view of the abdominal aorta for aneurysm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chief complaint of chest pain, dyspnea (either sudden onset or increased severity of chronic dyspnea), syncope, or hypotension (systolic blood pressure <100 or shock index [heart rate divided by systolic blood pressure] >1)
Key exclusion criteria (7 listed)
- <18 years old
- Prisoner or ward of the state
- Trauma
- High acuity requiring treatment in resuscitation room
- Obvious cause of symptoms (e.g. acute GI bleed causing hypotension)
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 |
|---|---|---|
| Point-of-care ultrasound | Other | Early POCUS |
| Usual care | Other | Usual care |
Primary outcome
Time to appropriate intervention
Time frame: Within 30 days of presentation
Based on final diagnosis as determined by final review of the patient's overall visit in the medical record, it will be determined what the appropriate intervention(s) that the patient should have received. Subsequently, the amount of time that elapsed (minutes) between time the patient was roomed in the emergency department (ED) and time to when they received the intervention will be collected. All these time points are readily available in the electronic medical record in the patient care timeline. This outcome will help determine whether early POCUS affects how quickly patients receive appropriate intervention.
6 secondary outcomes
Diagnostic accuracy
Time frame: Within 30 days of presentation
Diagnostic certainty
Time frame: Within 2 days of presentation
Time to disposition
Time frame: Within 2 days of presentation
Total length of stay
Time frame: Within 30 days of presentation
30-day in-hospital mortality
Time frame: Within 30 days of presentation
Duration of POCUS
Time frame: Within 2 days of presentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: No. No specific plans for now but would be open to sharing anonymized data.
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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.
Christopher Moore, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care ultrasound in people with Chest Pain and Dyspnea, run by Yale University 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 28 Feb 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to appropriate intervention (time frame: Within 30 days of presentation). 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 28 Feb 2020.