EchocardiographyNCT04810520
Live Stream of Prehospital point-of Care Ultrasound by Air Rescue Physicians
An observational study of Echocardiography and Telemedicine, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echocardiography, Telemedicine
- What is being tested?
- Point-of-care ultrasound with tele-supervision and Point-of-care ultrasound without tele-supervision
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- age under 18
- if POCUS will lead to a delay of live-saving treatment or transportation
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Anaesthesia & General Intensive Care
Vienna, 1090
About this study
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.
- Conditions
- Echocardiography, Telemedicine
- Being tested
- Point-of-care ultrasound with tele-supervision, Point-of-care ultrasound without tele-supervision
- Keywords
- Ultrasound diagnostics, Prehospital emergency medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 without tele-supervisionOther
Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed with tele-supervision.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Point-of-care ultrasound without tele-supervision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Alteration of treatent strategies
Investigating the impact of POCUS with tele-supervision in comparison to POCUS without tele-supervision on alteration of treatment strategies.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: No participants enrolled due to organizational problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchocardiographyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Hafner, Medical University of Vienna
- Investigators
- Department of Anaesthesia & General Intensive Care, Study chair, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810520
- Sponsor's protocol ID
- 1218/2021
- Status last verified
- Jan 2023
- First submitted
- 16 Mar 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Stream of Prehospital point-of Care Ultrasound by Air Rescue Physicians
- ClinicalTrials.gov ID
- NCT04810520
- Acronym / sponsor ID
- 1218/2021
- Conditions
- Echocardiography, Telemedicine
- Keywords
- Ultrasound diagnostics, Prehospital emergency medicine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled due to organizational problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Point-of-care ultrasound with tele-supervision | – | Other: Point-of-care ultrasound with tele-supervisionPoint-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 | – | Other: Point-of-care ultrasound without tele-supervisionPoint-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed without tele-supervision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (2 listed)
- age under 18
- if POCUS will lead to a delay of live-saving treatment or transportation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care ultrasound with tele-supervisionPoint-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-supervisionPoint-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed with tele-supervision. | Other | Point-of-care ultrasound without tele-supervision |
Primary outcome
Duration of prehospital ultrasound between POCUS with or without tele-supervision
Time frame: through study completion, an average of 1 year
duration of prehospital ultrasound between POCUS with tele-supervision and POCUS without tele-supervision in critically ill patients (acute dyspnoea, circulatory failure, trauma).
1 secondary outcome
Alteration of treatent strategies
Time frame: through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Echocardiography
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Recruiting
Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians in Heart Failure
Heart Failure
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Anaesthesia & General Intensive Care study chair
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Echocardiography and Telemedicine, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of prehospital ultrasound between POCUS with or without tele-supervision (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.