Cardiopulmonary ResuscitationNCT04817475
Live Stream of Prehospital point-of Care Ultrasound During Cardiopulmonary Resuscitation
An observational study of Cardiopulmonary Resuscitation and Echocardiography, 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 out-of-hospital cardiac arrest (OHCA) for diagnosis and treatment of reversible causes. However, in prehospital emergency medicine 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
- Cardiopulmonary Resuscitation, Echocardiography, Ultrasound
- What is being tested?
- Point-of-care ultrasound with tele-supervision
- How many people
- 44 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2021to 30 Aug 2023
- 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: 30 critically ill patients suffering from acute cardiopulmonary resuscitation will be included in this study. POCUS will be performed with tele-supervision.
Who may be able to join
- Patients with prehospital cardiac arrest, where POCUS is considered during cardiac pulmonary resuscitation, will be included.
Who cannot join
- under the age of 18,
- if POCUS is not considered or if POCUS will lead to a delay of live-saving treatment or transportation.
- pregnant patients
- patients with a body-mass-index (BMI) above 35 kg/m2
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 out-of-hospital cardiac arrest (OHCA) for diagnosis and treatment of reversible causes. However, in prehospital emergency medicine 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 the performance of POCUS during OHCA is unclear.
Aims: This prospective observational study aims to evaluate if POCUS with tele-supervision can be performed during CPR without any additional hands-off periods longer than 5 seconds.
Methods: In total 30 patients with OHCA, where POCUS is considered, will be included in this study.
- Conditions
- Cardiopulmonary Resuscitation, Echocardiography, Ultrasound
- Being tested
- Point-of-care ultrasound with tele-supervision
- Keywords
- Ultrasound diagnstics, Prehospital emergency medicine, Telemedicine
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 patients with a out-of-hospital cardiac arrest will be performed with tele-supervision.
| Study group | Role | What they receive |
|---|---|---|
| Point-of-care ultrasound with tele-supervision | Point-of-care ultrasound of patients with a out-of-hospital cardiac arrest will be performed with tele-supervision. Receives: Other: Point-of-care ultrasound with tele-supervision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hands-off time during prehospital cardiopulmonary resuscitation
The primary outcome of this study evaluates, if POCUS with tele-supervision can be performed during prehospital cardiopulmonary resuscitation without any additional hands-off period longer than 5 seconds
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Impact of real-time supervision of POCUS during cardiopulmonary resuscitation on the duration time of POCUS
Impact of real-time supervision of POCUS during cardiopulmonary resuscitation on the duration time of POCUS
Measured: through study completion, an average of 1 year
Impact of real-time supervision of POCUS during cardiopulmonary resuscitation on changing of diagnosis of suspected cause of out-of-hospital cardiac arrest.
Impact of real-time supervision of POCUS during cardiopulmonary resuscitation on changing of diagnosis of suspected cause of out-of-hospital cardiac arrest.
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 posted26 Mar 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ResuscitationStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 44 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
- NCT04817475
- Sponsor's protocol ID
- 2410/2020
- Status last verified
- Oct 2023
- First submitted
- 23 Mar 2021
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hafner C, Manschein V, Klaus DA, Schaubmayr W, Tiboldi A, Scharner V, Gleiss A, Thal B, Krammel M, Hamp T, Willschke H, Hermann M. Live stream of prehospital point-of-care ultrasound during cardiopulmonary resuscitation - A feasibility trial. Resuscitation. 2024 Jan;194:110089. doi: 10.1016/j.resuscitation.2023.110089. Epub 2023 Dec 16.
PubMed 38110144
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Stream of Prehospital point-of Care Ultrasound During Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT04817475
- Acronym / sponsor ID
- 2410/2020
- Conditions
- Cardiopulmonary Resuscitation, Echocardiography, Ultrasound
- Keywords
- Ultrasound diagnstics, Prehospital emergency medicine, Telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 26 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 out-of-hospital cardiac arrest (OHCA) for diagnosis and treatment of reversible causes. However, in prehospital emergency medicine 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 the performance of POCUS during OHCA is unclear.
Aims: This prospective observational study aims to evaluate if POCUS with tele-supervision can be performed during CPR without any additional hands-off periods longer than 5 seconds.
Methods: In total 30 patients with OHCA, where POCUS is considered, will be included in this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Point-of-care ultrasound with tele-supervision | – | Other: Point-of-care ultrasound with tele-supervisionPoint-of-care ultrasound of patients with a out-of-hospital cardiac arrest will be performed with tele-supervision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 critically ill patients suffering from acute cardiopulmonary resuscitation will be included in this study. POCUS will be performed with tele-supervision.
Key inclusion criteria (1 listed)
- Patients with prehospital cardiac arrest, where POCUS is considered during cardiac pulmonary resuscitation, will be included.
Key exclusion criteria (4 listed)
- under the age of 18,
- if POCUS is not considered or if POCUS will lead to a delay of live-saving treatment or transportation.
- pregnant patients
- patients with a body-mass-index (BMI) above 35 kg/m2
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 patients with a out-of-hospital cardiac arrest will be performed with tele-supervision. | Other | Point-of-care ultrasound with tele-supervision |
Primary outcome
Hands-off time during prehospital cardiopulmonary resuscitation
Time frame: through study completion, an average of 1 year
The primary outcome of this study evaluates, if POCUS with tele-supervision can be performed during prehospital cardiopulmonary resuscitation without any additional hands-off period longer than 5 seconds
2 secondary outcomes
Impact of real-time supervision of POCUS during cardiopulmonary resuscitation on the duration time of POCUS
Time frame: through study completion, an average of 1 year
Impact of real-time supervision of POCUS during cardiopulmonary resuscitation on changing of diagnosis of suspected cause of out-of-hospital cardiac arrest.
Time frame: through study completion, an average of 1 year
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 26 Oct 2023.
- Derived from this study: PubMed 38110144Hafner C, Manschein V, Klaus DA, Schaubmayr W, Tiboldi A, Scharner V, Gleiss A, Thal B, Krammel M, Hamp T, Willschke H, Hermann M. Live stream of prehospital point-of-care ultrasound during cardiopulmonary resuscitation - A feasibility trial. Resuscitation. 2024 Jan;194:110089. doi: 10.1016/j.resuscitation.2023.110089. Epub 2023 Dec 16.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiopulmonary Resuscitation
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Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
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The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
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 Cardiopulmonary Resuscitation and Echocardiography, 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 1 inclusion and 4 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 26 Oct 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 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?
Hands-off time during prehospital cardiopulmonary resuscitation (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?
On the ClinicalTrials.gov record for NCT04817475, which also lists 1 linked publication.
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 26 Oct 2023.