DyspneaNCT05782478
Added Diagnostic Value of Point of Care Ultrasound in Acute Dyspnea
An observational study of Dyspnea and Hypoxia, run by Region Skane at 2 sites in Sweden.
Trial summary
Dyspnea is a common diagnostic challenge in the Emergency Department (ED). Delay in diagnosis will increase time to correct treatment and could impact outcome. Previous studies have shown excellent diagnostic performance of point of care ultrasound (POCUS) to detect and differentiate between several important… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Point of care Ultrasound according to study protocol
- How many people
- 160 participants
- Where
- 2 sitesSweden
- Study dates
- 9 Mar 2023to 28 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients presenting to the Emergency Department at Skåne University Hospital in Lund or Helsingborg Hospital, Sweden.
Who may be able to join
- Adult patients presenting to the Emergency Department within the highest or second highest triage category and any of the following
- Presenting with shortness of breath
- Oxygen saturation less than 90 % on room air
- Respiratory rate more than 25 breaths per minute and oxygen saturation less than 95 % on room air
- Patient is discharge from the Emergency Department (without hospital admission)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Department of Emergency Medicine, Helsingborg Hospital
Helsingborg, Skåne County
Jakob L Forberg, MD,PhD
Jakob L Forberg, MD, PhD
- Recruiting
Department of Emergency Medicine, Skåne University Hospital
Lund, Skåne County
Eric Dryver, MD
Eric Dryver, MD
About this study
Official title: Added Diagnostic Value of Point of Care Ultrasound in Acute Dyspnea: a Prospective Observational Study
Dyspnea is a common diagnostic challenge in the Emergency Department (ED). Delay in diagnosis will increase time to correct treatment and could impact outcome. Previous studies have shown excellent diagnostic performance of point of care ultrasound (POCUS) to detect and differentiate between several important diagnosis (e.g heart failure and pneumonia) in patients with dyspnea. However, in most studies POCUS is performed by physicians highly experienced in ultrasound and often studies have focused only on one or few diagnoses. The aim of this study is to compare the diagnostic accuracy of different diagnosis in dyspnoeic patients before and after a ED physician with limited training applies POCUS.
Read the detailed description
Dyspnoea is a common presenting complaint in the Emergency Department (ED). Dyspnoea requires timely evaluation and treatment as several conditions causing dyspnea are time critical.
Previous studies have suggested that point-of-care ultrasound (POCUS) increase diagnostic accuracy in the initial assessment of patients with dyspnoea. However, in most studies POCUS was done by highly experienced physicians which could limit the generalisability of POCUS in the hands of all emergency specialist and residents.
Aim To evaluate whether POCUS performed by a variety of emergency medicine physicians (specialists and residents) increase diagnostic accuracy in patients with dyspnea compared to routine assessment.
Method:
Specialist and residents in Emergency Medicine at the ED in Lund and Helsingborg (Sweden) will have a short training and certification in a structured dyspnea POCUS protocol. The protocol includes focused lung (8 or 14 zones), heart (subcostal, parasternal and apical four chamber views) and inferior vena cava ultrasound.
Study design Prospective observational study
Study population
Inclusion criteria
Adult patients presenting to the Emergency Department within the highest or second highest triage category (Rapid Emergency Triage and Treatment System) and any of the following:
- Presenting with shortness of breath
- Oxygen saturation less than 90 % on room air
- Respiratory rate more than 25 breaths per minute and oxygen saturation less than 95 % on room air
Exclusion criteria
- Inclusion in the study will delay urgent interventions
- Patient is discharge from the ED (without hospital admission)
Patients will be included when a physician certified in the dyspnea POUCUS protocol is present in the ED (convenience sample) Firstly, an ED physician will assess the patient using available routine diagnostic procedures. After consent to the study, the physician will document the estimated likelihood (not likely, unlikely, likely, very likely) of the following diagnosis: heart failure, pulmonary embolism, pneumonia, exacerbation of chronic obstructive pulmonary disease (COPD), exacerbation of asthma, pleural or pericardial fluid. Clinical bedside tests will be available as in routine practice in the ED (e.g., ecg, blood gas results). A physician certified in the dyspnea protocol will then perform POCUS and deliver the findings to the initial physician assessing the patients. Hereafter, the initial physician documents the estimated likelihood of the above diagnosis being provided the ultrasound findings.
The estimated likelihoods (before and after POCUS) will be dichotomised and compared to the discharge diagnosis. Sensitivity, specificity, negative and positive predictive values of the diagnostic accuracy before and after adding POCUS will be calculated.
In addition to routine bed-side tests alle included patients will have the following ordered: chest imaging (x-ray or CT according to ED physicians' choice), N-terminal pro-B-type natriuretic peptide (pro-BNP), C-reactive protein and white blood count.
- Being tested
- Point of care Ultrasound according to study protocol
- Keywords
- Ultrasound, Point of care ultrasound
- Medical subject headings
- Dyspnea, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care Ultrasound according to study protocolDiagnostic test
An emergency medicine specialist or resident will according to a structured protocol perform a structured ultrasound examination of the heart, the inferior vena cava and the lungs.
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge diagnosis
Any of the following diagnosis: Decompensated heart failure, pulmonary embolism, COPD exacerbation, asthma exacerbation, bacterial pneumonia, viral pneumonia, pleural fluid, pericardial fluid
Measured: Final diagnosis at index visit discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start9 Mar 2023
- Primary completion31 Jan 2026 (estimated)
- Study completion28 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakob Lundager Forberg, PhD,MD, Principal investigator, Region Skåne Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782478
- Sponsor's protocol ID
- 2022-02789-01
- Status last verified
- Jun 2025
- First submitted
- 8 Mar 2023
- Last updated
- 16 Jul 2025
- 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 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Diagnostic Value of Point of Care Ultrasound in Acute Dyspnea: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05782478
- Acronym / sponsor ID
- 2022-02789-01
- Keywords
- Ultrasound, Point of care ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 28 Mar 2026 (estimated)
- First posted
- 23 Mar 2023 (actual)
- 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.
Dyspnea is a common diagnostic challenge in the Emergency Department (ED). Delay in diagnosis will increase time to correct treatment and could impact outcome. Previous studies have shown excellent diagnostic performance of point of care ultrasound (POCUS) to detect and differentiate between several important diagnosis (e.g heart failure and pneumonia) in patients with dyspnea. However, in most studies POCUS is performed by physicians highly experienced in ultrasound and often studies have focused only on one or few diagnoses. The aim of this study is to compare the diagnostic accuracy of different diagnosis in dyspnoeic patients before and after a ED physician with limited training applies POCUS.
Detailed description
Dyspnoea is a common presenting complaint in the Emergency Department (ED). Dyspnoea requires timely evaluation and treatment as several conditions causing dyspnea are time critical.
Previous studies have suggested that point-of-care ultrasound (POCUS) increase diagnostic accuracy in the initial assessment of patients with dyspnoea. However, in most studies POCUS was done by highly experienced physicians which could limit the generalisability of POCUS in the hands of all emergency specialist and residents.
Aim To evaluate whether POCUS performed by a variety of emergency medicine physicians (specialists and residents) increase diagnostic accuracy in patients with dyspnea compared to routine assessment.
Method:
Specialist and residents in Emergency Medicine at the ED in Lund and Helsingborg (Sweden) will have a short training and certification in a structured dyspnea POCUS protocol. The protocol includes focused lung (8 or 14 zones), heart (subcostal, parasternal and apical four chamber views) and inferior vena cava ultrasound.
Study design Prospective observational study
Study population
Inclusion criteria
Adult patients presenting to the Emergency Department within the highest or second highest triage category (Rapid Emergency Triage and Treatment System) and any of the following:
- Presenting with shortness of breath
- Oxygen saturation less than 90 % on room air
- Respiratory rate more than 25 breaths per minute and oxygen saturation less than 95 % on room air
Exclusion criteria
- Inclusion in the study will delay urgent interventions
- Patient is discharge from the ED (without hospital admission)
Patients will be included when a physician certified in the dyspnea POUCUS protocol is present in the ED (convenience sample) Firstly, an ED physician will assess the patient using available routine diagnostic procedures. After consent to the study, the physician will document the estimated likelihood (not likely, unlikely, likely, very likely) of the following diagnosis: heart failure, pulmonary embolism, pneumonia, exacerbation of chronic obstructive pulmonary disease (COPD), exacerbation of asthma, pleural or pericardial fluid. Clinical bedside tests will be available as in routine practice in the ED (e.g., ecg, blood gas results). A physician certified in the dyspnea protocol will then perform POCUS and deliver the findings to the initial physician assessing the patients. Hereafter, the initial physician documents the estimated likelihood of the above diagnosis being provided the ultrasound findings.
The estimated likelihoods (before and after POCUS) will be dichotomised and compared to the discharge diagnosis. Sensitivity, specificity, negative and positive predictive values of the diagnostic accuracy before and after adding POCUS will be calculated.
In addition to routine bed-side tests alle included patients will have the following ordered: chest imaging (x-ray or CT according to ED physicians' choice), N-terminal pro-B-type natriuretic peptide (pro-BNP), C-reactive protein and white blood count.
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
- Adult patients presenting to the Emergency Department at Skåne University Hospital in Lund or Helsingborg Hospital, Sweden.
Key inclusion criteria (5 listed)
- Adult patients presenting to the Emergency Department within the highest or second highest triage category and any of the following
- Presenting with shortness of breath
- Oxygen saturation less than 90 % on room air
- Respiratory rate more than 25 breaths per minute and oxygen saturation less than 95 % on room air
- Patient is discharge from the Emergency Department (without hospital admission)
Key exclusion criteria (0 listed)
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 according to study protocolAn emergency medicine specialist or resident will according to a structured protocol perform a structured ultrasound examination of the heart, the inferior vena cava and the lungs. | Diagnostic test | – |
Primary outcome
Discharge diagnosis
Time frame: Final diagnosis at index visit discharge
Any of the following diagnosis: Decompensated heart failure, pulmonary embolism, COPD exacerbation, asthma exacerbation, bacterial pneumonia, viral pneumonia, pleural fluid, pericardial fluid
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
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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.
Jakob Lundager Forberg, PhD,MD principal investigator
Region Skåne Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea and Hypoxia, run by Region Skane at 2 sites in Sweden.
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 5 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakob Lundager Forberg, PhD,MD (0046424061000, jakob.lundager-forberg@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discharge diagnosis (time frame: Final diagnosis at index visit discharge). 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 16 Jul 2025.