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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04817488
Other study ID # 2411/2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date December 30, 2024

Study information

Verified date October 2023
Source Medical University of Vienna
Contact Christina Hafner, MD, PhD
Phone + 43 1 40400 41000
Email christina.hafner@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 350
Est. completion date December 30, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Prehospital emergency ultrasound with tele-supervision
Prehospital emergency ultrasound with tele-supervision in patients with acute dyspnoea
Prehospital emergency ultrasound without tele-supervision
Prehospital emergency ultrasound without tele-supervision in patients with acute dyspnoea

Locations

Country Name City State
Austria Medical University of Vienna, Department of Anaesthesia & General Intensive Care Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of prehospital diagnosis after PEU in relation to the (correct) in-hospital diagnosis 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. through study completion, an average of 1 year
Secondary Agreement of diagnosis before PEU and after PEU Is there an agreement between the diagnosis before performing the prehospital emergency ultrasound (PEU) and after performing it. through study completion, an average of 1 year
Secondary Duration of prehospital emergency ultrasound (PEU) Duration of prehospital emergency ultrasound (PEU) through study completion, an average of 1 year
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