DyspneaNCT03905460
Point-of-care Ultrasound in Prehospital Dyspnea
An observational study of Dyspnea, run by University of Aarhus at 1 site in Denmark.
Trial summary
Point-of-care ultrasound in patients with dyspnoea has been shown to alter patient treatment and the time to correct treatment when performed in emergency departments. In Denmark, physician-staffed ambulances are sent to citizens with severe ABCD symptoms including dyspnoea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- Point-of-care ultrasound
- How many people
- 219 participants
- Where
- 1 siteDenmark
- Study dates
- 15 May 2019to 30 Dec 2021
- 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: All citizens who have contacted the Acute Medical Coordination center in the Central Denmark Region for emergency medical treatment.
Who may be able to join
- age >/= 18 years
- dyspnea as a dominating complaint At least one of
- respiratory frequency >25/minute
- oxygen saturation < 95%
- oxygen therapy initiated
Who cannot join
- trama patients
- prior enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Point-of-care Ultrasound in Prehospital Dyspnea: Game-changer or Gaming-gadgets?
Point-of-care ultrasound in patients with dyspnoea has been shown to alter patient treatment and the time to correct treatment when performed in emergency departments. In Denmark, physician-staffed ambulances are sent to citizens with severe ABCD symptoms including dyspnoea. Hence, there is a potential for correct diagnostics and appropriate treatment already in the citizens' own home or en route to the hospital. This study aims to evaluate the clinical performance of prehospital point-of-care ultrasound in patients with dyspnoea.
- Conditions
- Dyspnea
- Being tested
- Point-of-care ultrasound
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care ultrasoundDiagnostic test
Focused ultrasound of the heart, lungs and pleurae
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for diagnosing heart failure
Change in sensitivity for diagnosing heart failure when adding point-of-care ultrasound to the clinical examination
Measured: From initial citizen contact to end of ultrasound examination within 15 minutes
Secondary outcomes (5)
Sensitivity, clinical exam
Sensitivity of clinical examination for for diagnosing heart failure. Held up against a post-hoc expert panel statement.
Measured: From initial citizen contact and within a time-span of 15 minutes
Sensitivity, Ultrasound examination
Sensitivity of clinical examination supplemented with ultrasound scan for diagnosing heart failure. Held up against a post-hoc expert panel statement.
Measured: From initial citizen contact and within a time-span of 15 minutes
Treatment changes in medicine caused by ultrasound examination
Changes in medical treatment including diuretics, nitric oxide, bronkodilation and steroids caused by the addition of an ultrasound scan
Measured: From initial citizen contact and within a time-span of 15 minutes
Treatment changes in ventilation caused by ultrasound examination
Treatment changes ventilatory strategy including nasal cannula oxygen therapi, face mask or non-invasive positive pressure ventilation caused by the addition of an ultrasound scan
Measured: From initial citizen contact and within a time-span of 15 minutes
Triage changes caused by ultrasound examination
Change in the department or hospital that the patient is sent to as a cause of an ultrasound scan
Measured: From initial citizen contact and within a time-span of 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start15 May 2019
- Primary completion1 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Randers Regional Hospital
- Responsible party
- Principal investigator, Morten Thingemann Bøtker, University of Aarhus
- Investigators
- Morten Bøtker, MD, Phd, Principal investigator, Prehospital of Central Denmark Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905460
- Sponsor's protocol ID
- POC Ultrasound
- Status last verified
- Nov 2022
- First submitted
- 21 Mar 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gundersen EA, Juhl-Olsen P, Bach A, Rostgaard-Knudsen M, Nielsen BRR, Skaarup SH, Petersen HO, Fjolner J, Poulsen MGG, Botker MT. PrehospitaL Ultrasound in Undifferentiated DyspnEa (PreLUDE): a prospective, clinical, observational study. Scand J Trauma Resusc Emerg Med. 2023 Feb 5;31(1):6. doi: 10.1186/s13049-023-01070-4.
PubMed 36740691
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-care Ultrasound in Prehospital Dyspnea: Game-changer or Gaming-gadgets?
- ClinicalTrials.gov ID
- NCT03905460
- Acronym / sponsor ID
- POC Ultrasound
- Conditions
- Dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Randers Regional Hospital
- Study start
- 15 May 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 5 Apr 2019 (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.
Point-of-care ultrasound in patients with dyspnoea has been shown to alter patient treatment and the time to correct treatment when performed in emergency departments. In Denmark, physician-staffed ambulances are sent to citizens with severe ABCD symptoms including dyspnoea. Hence, there is a potential for correct diagnostics and appropriate treatment already in the citizens' own home or en route to the hospital. This study aims to evaluate the clinical performance of prehospital point-of-care ultrasound in patients with dyspnoea.
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
- All citizens who have contacted the Acute Medical Coordination center in the Central Denmark Region for emergency medical treatment.
Key inclusion criteria (5 listed)
- age >/= 18 years
- dyspnea as a dominating complaint At least one of
- respiratory frequency >25/minute
- oxygen saturation < 95%
- oxygen therapy initiated
Key exclusion criteria (2 listed)
- trama patients
- prior enrollment
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 ultrasoundFocused ultrasound of the heart, lungs and pleurae | Diagnostic test | – |
Primary outcome
Sensitivity for diagnosing heart failure
Time frame: From initial citizen contact to end of ultrasound examination within 15 minutes
Change in sensitivity for diagnosing heart failure when adding point-of-care ultrasound to the clinical examination
5 secondary outcomes
Sensitivity, clinical exam
Time frame: From initial citizen contact and within a time-span of 15 minutes
Sensitivity, Ultrasound examination
Time frame: From initial citizen contact and within a time-span of 15 minutes
Treatment changes in medicine caused by ultrasound examination
Time frame: From initial citizen contact and within a time-span of 15 minutes
Treatment changes in ventilation caused by ultrasound examination
Time frame: From initial citizen contact and within a time-span of 15 minutes
Triage changes caused by ultrasound examination
Time frame: From initial citizen contact and within a time-span of 60 minutes
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 2 Nov 2022.
- Derived from this study: PubMed 36740691Gundersen EA, Juhl-Olsen P, Bach A, Rostgaard-Knudsen M, Nielsen BRR, Skaarup SH, Petersen HO, Fjolner J, Poulsen MGG, Botker MT. PrehospitaL Ultrasound in Undifferentiated DyspnEa (PreLUDE): a prospective, clinical, observational study. Scand J Trauma Resusc Emerg Med. 2023 Feb 5;31(1):6. doi: 10.1186/s13049-023-01070-4.
- Individual participant dataSharing planned: No
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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.
Morten Bøtker, MD, Phd principal investigator
Prehospital of Central Denmark Region
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 Dyspnea, run by University of Aarhus at 1 site in Denmark.
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 2 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 2 Nov 2022. 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 Denmark. 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?
Sensitivity for diagnosing heart failure (time frame: From initial citizen contact to end of ultrasound examination within 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03905460, which also lists 1 linked publication.
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 2 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.