UltrasoundNCT04612816
Live Stream of Ultrasound in Prehospital Medical Care
An observational study of Ultrasound, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Prehospital emergency ultrasound (PEU) is being increasingly used in different preclinical emergency systems across the world. Ultrasound examinations in emergency situations, however, remain challenging even in the hospital setting despite the availability of standardized approaches such as Focused Assessment with… Read more about this study
- Who is it for?
- Ages 18 to 116 years
- Conditions the study is for
- Ultrasound
- What is being tested?
- Prehospital ultrasound
- How many people
- 25 participants
- Where
- 1 siteAustria
- Study dates
- 19 Oct 2020to 31 Aug 2021
- 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 to 116 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PEU should be implemented in the management of emergency patients affected by trauma, cardiac arrest/shock or respiratory problems.
Who may be able to join
- Emergency patients affected by:
- trauma
- cardiac arrest/shock
- respiratory problems
Who cannot join
- Patients rejection.
- Legal representative's rejection.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna - Division of General Anaesthesia and Intensive Care Medicine
Vienna, 1090
About this study
Official title: Live Stream of Emergency Ultrasound to Improve Diagnostics in Prehospital Medical Care: a Feasibility Study
Prehospital emergency ultrasound (PEU) is being increasingly used in different preclinical emergency systems across the world. Ultrasound examinations in emergency situations, however, remain challenging even in the hospital setting despite the availability of standardized approaches such as Focused Assessment with Sonography for Trauma (FAST). Preclinical circumstances further complicate the adequate execution of an additional diagnostic tool such as PEU on the scene or inside a medical emergency vehicle. Furthermore, rapid translation of ultrasound findings into meaningful therapeutic consequences is considerably demanding in an environment of limited resources. If focused PEU is correctly used and patients' condition allows emergency doctors a careful ultrasound examination, it is possible to differentiate life-threatening diagnoses. PEU should be implemented in the management of emergency patients affected by trauma, cardiac arrest/shock or respiratory problems. To date it is unclear whether PEU results in improved outcome.
Some emergency cases present difficult challenges in the prehospital ultrasound examination. Portable devices designed for PEU suggest the possibility of increasing the use of ultrasound "in the field". However, to the investigator's knowledge, opportunities for real-time consultation with a second specialist including live transmission of the ultrasound picture are not being provided at any preclinical emergency facility.
Read the detailed description
Aim 1:
Feasibility of real time prehospital emergency ultrasound (PEU) transmission in a university affiliated preclinical emergency system.
Aim 2:
Identify obstacles for PEU transmission including a real time consultation of an ultrasound expert.
Hypothesis:
We expect that live streaming of emergency ultrasound images in order to allow a second opinion could improve diagnostics of life threatening conditions and help us to improve patients' safety by digital health. The use of PEU is feasible and safe.
- Conditions
- Ultrasound
- Being tested
- Prehospital ultrasound
- Keywords
- echocardiography, emergency medicine, telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehospital ultrasoundOther
Feasibility of real time PEU transmission in a university affiliated preclinical emergency system.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of PEU live stream.
Numerical scale (1-10; 1 = best, 10 = poor)
Measured: 3 Months
Secondary outcomes (6)
Identify obstacles for PEU transmission including a real time consultation of an ultrasound expert.
Expert available on time? Communication? Duration of ultrasound examination? Duration of live stream? Delay by PEU transmission? Emergency duration with/without PEU transmission Technical problems?
Measured: 3 Months
Identify obstacles for PEU transmission including a real time consultation of an ultrasound expert.
Communication?
Measured: 3 Months
Identify obstacles for PEU transmission including a real time consultation of an ultrasound expert.
Duration of ultrasound examination?
Measured: 3 Months
Identify obstacles for PEU transmission including a real time consultation of an ultrasound expert.
Duration of live stream?
Measured: 3 Months
Identify obstacles for PEU transmission including a real time consultation of an ultrasound expert.
Delay by PEU transmission?
Measured: 3 Months
Identify obstacles for PEU transmission including a real time consultation of an ultrasound expert.
Emergency duration with/without PEU transmission technical problems?
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start19 Oct 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for UltrasoundStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Loinger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612816
- Sponsor's protocol ID
- Prehospital Ultrasound LBI/MUV
- Status last verified
- Sep 2021
- First submitted
- 20 Oct 2020
- Last updated
- 14 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Botker MT, Jacobsen L, Rudolph SS, Knudsen L. The role of point of care ultrasound in prehospital critical care: a systematic review. Scand J Trauma Resusc Emerg Med. 2018 Jun 26;26(1):51. doi: 10.1186/s13049-018-0518-x.
PubMed 29940990van der Weide L, Popal Z, Terra M, Schwarte LA, Ket JCF, Kooij FO, Exadaktylos AK, Zuidema WP, Giannakopoulos GF. Prehospital ultrasound in the management of trauma patients: Systematic review of the literature. Injury. 2019 Dec;50(12):2167-2175. doi: 10.1016/j.injury.2019.09.034. Epub 2019 Sep 28.
PubMed 31627899Scharonow M, Weilbach C. Prehospital point-of-care emergency ultrasound: a cohort study. Scand J Trauma Resusc Emerg Med. 2018 Jun 18;26(1):49. doi: 10.1186/s13049-018-0519-9.
PubMed 29914554Ketelaars R, Reijnders G, van Geffen GJ, Scheffer GJ, Hoogerwerf N. ABCDE of prehospital ultrasonography: a narrative review. Crit Ultrasound J. 2018 Aug 8;10(1):17. doi: 10.1186/s13089-018-0099-y.
PubMed 30088160Marsh-Feiley G, Eadie L, Wilson P. Telesonography in emergency medicine: A systematic review. PLoS One. 2018 May 3;13(5):e0194840. doi: 10.1371/journal.pone.0194840. eCollection 2018.
PubMed 29723198Schmid M, Dodt C. [Emergency lung ultrasound]. Med Klin Intensivmed Notfmed. 2018 Nov;113(8):616-624. doi: 10.1007/s00063-018-0485-z. Epub 2018 Oct 10. German.
PubMed 30306189Hermann M, Hafner C, Scharner V, Hribersek M, Maleczek M, Schmid A, Schaden E, Willschke H, Hamp T. Remote real-time supervision of prehospital point-of-care ultrasound: a feasibility study. Scand J Trauma Resusc Emerg Med. 2022 Mar 24;30(1):23. doi: 10.1186/s13049-021-00985-0.
PubMed 35331304
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Stream of Emergency Ultrasound to Improve Diagnostics in Prehospital Medical Care: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04612816
- Acronym / sponsor ID
- Prehospital Ultrasound LBI/MUV
- Conditions
- Ultrasound
- Keywords
- echocardiography, emergency medicine, telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 3 Nov 2020 (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.
Prehospital emergency ultrasound (PEU) is being increasingly used in different preclinical emergency systems across the world. Ultrasound examinations in emergency situations, however, remain challenging even in the hospital setting despite the availability of standardized approaches such as Focused Assessment with Sonography for Trauma (FAST). Preclinical circumstances further complicate the adequate execution of an additional diagnostic tool such as PEU on the scene or inside a medical emergency vehicle. Furthermore, rapid translation of ultrasound findings into meaningful therapeutic consequences is considerably demanding in an environment of limited resources. If focused PEU is correctly used and patients' condition allows emergency doctors a careful ultrasound examination, it is possible to differentiate life-threatening diagnoses. PEU should be implemented in the management of emergency patients affected by trauma, cardiac arrest/shock or respiratory problems. To date it is unclear whether PEU results in improved outcome.
Some emergency cases present difficult challenges in the prehospital ultrasound examination. Portable devices designed for PEU suggest the possibility of increasing the use of ultrasound "in the field". However, to the investigator's knowledge, opportunities for real-time consultation with a second specialist including live transmission of the ultrasound picture are not being provided at any preclinical emergency facility.
Detailed description
Aim 1:
Feasibility of real time prehospital emergency ultrasound (PEU) transmission in a university affiliated preclinical emergency system.
Aim 2:
Identify obstacles for PEU transmission including a real time consultation of an ultrasound expert.
Hypothesis:
We expect that live streaming of emergency ultrasound images in order to allow a second opinion could improve diagnostics of life threatening conditions and help us to improve patients' safety by digital health. The use of PEU is feasible and safe.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 116 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PEU should be implemented in the management of emergency patients affected by trauma, cardiac arrest/shock or respiratory problems.
Key inclusion criteria (4 listed)
- trauma
- cardiac arrest/shock
- respiratory problems
Key exclusion criteria (2 listed)
- Patients rejection.
- Legal representative's rejection.
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 |
|---|---|---|
| Prehospital ultrasoundFeasibility of real time PEU transmission in a university affiliated preclinical emergency system. | Other | – |
Primary outcome
Quality of PEU live stream.
Time frame: 3 Months
Numerical scale (1-10; 1 = best, 10 = poor)
6 secondary outcomes
Identify obstacles for PEU transmission including a real time consultation of an ultrasound expert.
Time frame: 3 Months
Identify obstacles for PEU transmission including a real time consultation of an ultrasound expert.
Time frame: 3 Months
Identify obstacles for PEU transmission including a real time consultation of an ultrasound expert.
Time frame: 3 Months
Identify obstacles for PEU transmission including a real time consultation of an ultrasound expert.
Time frame: 3 Months
Identify obstacles for PEU transmission including a real time consultation of an ultrasound expert.
Time frame: 3 Months
Identify obstacles for PEU transmission including a real time consultation of an ultrasound expert.
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Background: PubMed 29940990Botker MT, Jacobsen L, Rudolph SS, Knudsen L. The role of point of care ultrasound in prehospital critical care: a systematic review. Scand J Trauma Resusc Emerg Med. 2018 Jun 26;26(1):51. doi: 10.1186/s13049-018-0518-x.
- Background: PubMed 31627899van der Weide L, Popal Z, Terra M, Schwarte LA, Ket JCF, Kooij FO, Exadaktylos AK, Zuidema WP, Giannakopoulos GF. Prehospital ultrasound in the management of trauma patients: Systematic review of the literature. Injury. 2019 Dec;50(12):2167-2175. doi: 10.1016/j.injury.2019.09.034. Epub 2019 Sep 28.
- Background: PubMed 29914554Scharonow M, Weilbach C. Prehospital point-of-care emergency ultrasound: a cohort study. Scand J Trauma Resusc Emerg Med. 2018 Jun 18;26(1):49. doi: 10.1186/s13049-018-0519-9.
- Background: PubMed 30088160Ketelaars R, Reijnders G, van Geffen GJ, Scheffer GJ, Hoogerwerf N. ABCDE of prehospital ultrasonography: a narrative review. Crit Ultrasound J. 2018 Aug 8;10(1):17. doi: 10.1186/s13089-018-0099-y.
- Background: PubMed 29723198Marsh-Feiley G, Eadie L, Wilson P. Telesonography in emergency medicine: A systematic review. PLoS One. 2018 May 3;13(5):e0194840. doi: 10.1371/journal.pone.0194840. eCollection 2018.
- Background: PubMed 30306189Schmid M, Dodt C. [Emergency lung ultrasound]. Med Klin Intensivmed Notfmed. 2018 Nov;113(8):616-624. doi: 10.1007/s00063-018-0485-z. Epub 2018 Oct 10. German.
- Derived from this study: PubMed 35331304Hermann M, Hafner C, Scharner V, Hribersek M, Maleczek M, Schmid A, Schaden E, Willschke H, Hamp T. Remote real-time supervision of prehospital point-of-care ultrasound: a feasibility study. Scand J Trauma Resusc Emerg Med. 2022 Mar 24;30(1):23. doi: 10.1186/s13049-021-00985-0.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ultrasound, 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 4 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: finished, as of the sponsor's last update on 14 Sep 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of PEU live stream. (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04612816, which also lists 7 linked publications.
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 14 Sep 2021.