NCT04810520

Brief Summary

Background: Point-of-care ultrasound (POCUS) has been suggested as a useful tool in emergency medicine for diagnosis and treatment of reversible causes. However, in prehospital setting performing ultrasound and the translation of the findings can be challenging. As new prehospital ultrasound devices offer the possibility for remote supervision, the impact of tele-supervision on time to diagnosis of critically ill patients is unclear. Aims: The aim of this study is to evaluate the impact of tele-supervision on the time of POCUS in prehospital critically ill patients by air rescue physicians. Methods: In total 100 critically ill patients suffering from acute dyspnoea, circulatory failure or trauma, which are treated by air rescue physicians will be included in this study. Duration of ultrasound performance as well as altered treatment strategies will be analyzed.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

March 16, 2021

Last Update Submit

January 6, 2023

Conditions

EchocardiographyTelemedicine

Keywords

Ultrasound diagnosticsPrehospital emergency medicine

Outcome Measures

Primary Outcomes (1)

  • Duration of prehospital ultrasound between POCUS with or without tele-supervision

    duration of prehospital ultrasound between POCUS with tele-supervision and POCUS without tele-supervision in critically ill patients (acute dyspnoea, circulatory failure, trauma).

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Alteration of treatent strategies

    through study completion, an average of 1 year

Other Outcomes (1)

  • Accuracy of suspected diagnosis in comparison to clinical findings

    through study completion, an average of 1 year

Study Arms (2)

Point-of-care ultrasound with tele-supervision

Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed with tele-supervision.

Other: Point-of-care ultrasound with tele-supervision

Point-of-care ultrasound without tele-supervision

Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed without tele-supervision.

Other: Point-of-care ultrasound without tele-supervision

Interventions

Point-of-care ultrasound with tele-supervisionOTHER

Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed with tele-supervision.

Point-of-care ultrasound with tele-supervision
Point-of-care ultrasound without tele-supervisionOTHER

Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed with tele-supervision.

Point-of-care ultrasound without tele-supervision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

100 critically ill patients with acute dyspnoea, circulatory failure or trauma, will be included in this study. In 50 patients POCUS with tele-supervision and in 50 patients POCUS without tele-supervision will be performed. Tele-supervision is available in 50% of the time. Allocation to one of the two groups depends on the availability of tele-supervision.

You may qualify if:

  • Critically ill patients suffering from acute dyspnoea, circulatory failure or trauma will be included.
  • Patients with acute dyspnoea will be included, if they show at least one of the two following signs of respiratory failure:
  • Respiratory rate \> 20 breaths per minute
  • Peripheral oxygen saturation without oxygen supplementation \< 90%
  • Patients with acute circulatory failure will be included, if they show at least one of the following signs:
  • Hypotension (systolic blood pressure \<90mmHg)
  • Altered tissue perfusion (cold, clammy, mottling skin or altered mental status)
  • Trauma patients will be included, if at least one cause is suspected:
  • Intraabdominal fluid
  • Intrathoracic free fluid
  • Pneumothorax

You may not qualify if:

  • age under 18
  • if POCUS will lead to a delay of live-saving treatment or transportation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
0

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 16, 2021

First Posted

March 23, 2021

Study Start

November 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

January 10, 2023

Record last verified: 2023-01

Locations

AU(1)