- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04817488
Live Stream of Prehospital Emergency Ultrasound in Patients With Acute Dyspnoea
Background: Acute dyspnoea is a common symptom in prehospital emergency medicine. As ultrasound gained in importance for diagnosis in patients with acute respiratory distress, it plays even a role in the prehospital setting. However, prehospital emergency ultrasound (PEU) remains challenging and requires knowledge and skills. New prehospital ultrasound devices offer the possibility for tele-supervision. The impact of tele-supervision of PEU in patients with acute dyspnoea is unclear.
Objective: This prospective observational study aims to evaluate the effect of PEU with tele-supervision on diagnosis, treatment strategies and cognitive load in comparison to PEU without tele-supervision in patients with acute dyspnoea.
Methods: In total 350 prehospital emergency patients with acute dyspnoea will be included in this study. Patients will be observed in two groups. In group 1 PEU will be performed with tele-supervision, whereas in group 2 PEU will be performed without tele-supervision (tele-supervision not available).
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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-
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Vienna, Austria, 1090
- Medical University of Vienna, Department of Anaesthesia & General Intensive Care
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients will be included, if they suffer from acute dyspnoea and at least one of the two following signs of respiratory failure:
- Respiratory rate >20 breaths per minute
- Peripheral oxygen saturation without oxygen supplementation <90%
Exclusion Criteria:
- under the age of 18
- if PEU will lead to a delay of live-saving treatment or transportation
- if patient rejects the PEU, the patient will be excluded
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Prehospital emergency ultrasound with tele-supervision
Prehospital emergency ultrasound of patients with acute dyspnea will be performed with tele-supervision.
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Prehospital emergency ultrasound with tele-supervision in patients with acute dyspnoea
|
|
Prehospital emergency ultrasound without tele-supervision
Prehospital emergency ultrasound of patients with acute dyspnea will be performed without tele-supervision.
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Prehospital emergency ultrasound without tele-supervision in patients with acute dyspnoea
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of prehospital diagnosis after PEU in relation to the (correct) in-hospital diagnosis
Time Frame: through study completion, an average of 1 year
|
The aim of this study is to compare the accuracy of a prehospital emergency ultrasound (PEU) done with or without tele-supervison in patients suffering from acute dyspnoea and evaluate the accuracy of the diagnosis in relation to the (correct) in-hospital diagnosis.
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through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement of diagnosis before PEU and after PEU
Time Frame: through study completion, an average of 1 year
|
Is there an agreement between the diagnosis before performing the prehospital emergency ultrasound (PEU) and after performing it.
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through study completion, an average of 1 year
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Duration of prehospital emergency ultrasound (PEU)
Time Frame: through study completion, an average of 1 year
|
Duration of prehospital emergency ultrasound (PEU)
|
through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Department of Anaesthesia & General Intensive Care, Medical University of Vienna
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2411/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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