- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03905460
Point-of-care Ultrasound in Prehospital Dyspnea
November 1, 2022 updated by: Morten Thingemann Bøtker, University of Aarhus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
219
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Aarhus, Denmark
- Præhospitalet
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All citizens who have contacted the Acute Medical Coordination center in the Central Denmark Region for emergency medical treatment.
Description
Inclusion Criteria:
- age >/= 18 years
- dyspnea as a dominating complaint At least one of
- respiratory frequency >25/minute
- oxygen saturation < 95%
- oxygen therapy initiated
Exclusion Criteria:
- trama patients
- prior enrollment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From initial citizen contact to end of ultrasound examination within 15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity, clinical exam
Time Frame: From initial citizen contact and within a time-span of 15 minutes
|
Sensitivity of clinical examination for for diagnosing heart failure.
Held up against a post-hoc expert panel statement.
|
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
|
Sensitivity of clinical examination supplemented with ultrasound scan for diagnosing heart failure.
Held up against a post-hoc expert panel statement.
|
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
|
Changes in medical treatment including diuretics, nitric oxide, bronkodilation and steroids caused by the addition of an ultrasound scan
|
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
|
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
|
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
|
Change in the department or hospital that the patient is sent to as a cause of an ultrasound scan
|
From initial citizen contact and within a time-span of 60 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Morten Bøtker, MD, Phd, Prehospital of Central Denmark Region
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2019
Primary Completion (Actual)
December 1, 2021
Study Completion (Actual)
December 30, 2021
Study Registration Dates
First Submitted
March 21, 2019
First Submitted That Met QC Criteria
April 3, 2019
First Posted (Actual)
April 5, 2019
Study Record Updates
Last Update Posted (Actual)
November 2, 2022
Last Update Submitted That Met QC Criteria
November 1, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- POC Ultrasound
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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