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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Conditions the study is for
Dyspnea, Hypoxia
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.

Jakob Lundager Forberg, PhD,MD contact

0046424061000

jakob.lundager-forberg@skane.se

Sweden2 sites, 2 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

    Recruiting

Other trials in Sweden

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.

Conditions
Dyspnea, Hypoxia
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.

  1. 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.

  1. First posted23 Mar 2023
  2. Study start9 Mar 2023
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion28 Mar 2026 (estimated)

Resources

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)
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

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.

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