Live Stream of Prehospital Emergency Ultrasound in Patients With Acute Dyspnoea

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT04817488
Collaborator
(none)
350
1
34
10.3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Prehospital emergency ultrasound with tele-supervision
  • Other: Prehospital emergency ultrasound without tele-supervision

Study Design

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Live Stream of Prehospital Emergency Ultrasound in Patients With Acute Dyspnoea
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
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 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.

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

Outcome Measures

Primary Outcome Measures

  1. Accuracy of prehospital diagnosis after PEU in relation to the (correct) in-hospital diagnosis [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.

Secondary Outcome Measures

  1. Agreement of diagnosis before PEU and after PEU [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.

  2. Duration of prehospital emergency ultrasound (PEU) [through study completion, an average of 1 year]

    Duration of prehospital emergency ultrasound (PEU)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna, Department of Anaesthesia & General Intensive Care Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Study Chair: Department of Anaesthesia & General Intensive Care, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christina Hafner, Clinical Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT04817488
Other Study ID Numbers:
  • 2411/2020
First Posted:
Mar 26, 2021
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christina Hafner, Clinical Investigator, Medical University of Vienna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2022