- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04810520
Live Stream of Prehospital point-of Care Ultrasound by Air Rescue Physicians
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.
Study Overview
Status
Conditions
Study Type
Contacts and Locations
Study Locations
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-
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Vienna, Austria, 1090
- Medical University of Vienna, Department of Anaesthesia & General Intensive Care
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
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Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed with tele-supervision.
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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.
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Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed with tele-supervision.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of prehospital ultrasound between POCUS with or without tele-supervision
Time Frame: through study completion, an average of 1 year
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duration of prehospital ultrasound between POCUS with tele-supervision and POCUS without tele-supervision in critically ill patients (acute dyspnoea, circulatory failure, trauma).
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through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alteration of treatent strategies
Time Frame: through study completion, an average of 1 year
|
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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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of suspected diagnosis in comparison to clinical findings
Time Frame: through study completion, an average of 1 year
|
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.
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through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1218/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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