Live Stream of Prehospital Emergency Ultrasound in Patients With Acute Dyspnoea

NCT04817488 | Active Not Recruiting

• 1 other identifier: 2411/2020
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Echocardiography; Acute Dyspnea

Keywords

Ultrasound diagnostics; Prehospital emergency medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Agreement of diagnosis before PEU and after PEU

  through study completion, an average of 1 year

• Duration of prehospital emergency ultrasound (PEU)

  through study completion, an average of 1 year

Study Arms (2)

Prehospital emergency ultrasound with tele-supervision

Prehospital emergency ultrasound of patients with acute dyspnea will be performed with tele-supervision.

Other: Prehospital emergency ultrasound with tele-supervision

Prehospital emergency ultrasound without tele-supervision

Prehospital emergency ultrasound of patients with acute dyspnea will be performed without tele-supervision.

Other: Prehospital emergency ultrasound without tele-supervision

Interventions

Prehospital emergency ultrasound with tele-supervision OTHER

Prehospital emergency ultrasound with tele-supervision in patients with acute dyspnoea

Prehospital emergency ultrasound with tele-supervision

Prehospital emergency ultrasound without tele-supervision OTHER

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

Prehospital emergency ultrasound without tele-supervision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

350 critically ill patients with acute dyspnoea will be included in this study. In 175 patients ultrasound with tele-supervision and in 175 patients ultrasound without tele-supervision will be performed. Allocation to one of the two groups depends on the availability of tele-supervision. Tele-supervision is available in 50% of the time.

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department of Anaesthesia & General Intensive Care

Vienna, 1090, Austria

Location

Study Officials

• Department of Anaesthesia & General Intensive Care

  Medical University of Vienna

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: July 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

AU (1)