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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04810520
Other study ID # 1218/2021
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date December 31, 2022

Study information

Verified date January 2023
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 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 Exclusion Criteria: - age under 18 - if POCUS will lead to a delay of live-saving treatment or transportation

Study Design


Related Conditions & MeSH terms


Intervention

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

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
Other Accuracy of suspected diagnosis in comparison to clinical findings Investigating the impact of POCUS with tele-supervision in comparison to POCUS without tele-supervision on accuracy of suspected diagnosis in comparison to clinical findings. through study completion, an average of 1 year
Primary 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 Alteration of treatent strategies Investigating the impact of POCUS with tele-supervision in comparison to POCUS without tele-supervision on alteration of treatment strategies. through study completion, an average of 1 year
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