Echocardiography, TransesophagealNCT05185596
Prehospital TEE in Cardiac Arrest
A study testing Transesophageal Echocardiography in people with Echocardiography, Transesophageal and Out-of-Hospital Cardiac Arrest, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This study shall investigate the feasibility of prehospital performed trans-esophageal echocardiography in out of hospital cardiac arrest. The investigators will include ten patients undergoing advanced life support in this study and determine if it is possible to acquire adequate trans-esophageal images within 10… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echocardiography, Transesophageal, Out-of-Hospital Cardiac Arrest
- What is being tested?
- Transesophageal Echocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- 11 Dec 2021to 31 Aug 2022
- Phase
- Interventional
- 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
Who may be able to join
- adult patients undergoing advanced life support for out of hospital cardiac arrest
Who cannot join
- patients who should undergo rapid transport to the hospital with ongoing CPR (ECMO candidates, pregnant, trauma, obvious reversible which can be treated in hospital only)
- known esophageal pathology contraindicating TEE
- no definite secure airway present (endotracheal intubation, tracheostomy)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Thomas Hamp, M.D., +4340400 ext. 41030, thomas.hamp@meduniwien.ac.at
About this study
Official title: Feasibility of Prehospital Trans Esophageal Echocardiography in Cardiac Arrest
This study shall investigate the feasibility of prehospital performed trans-esophageal echocardiography in out of hospital cardiac arrest.
The investigators will include ten patients undergoing advanced life support in this study and determine if it is possible to acquire adequate trans-esophageal images within 10 minutes after arrival of the study team on scene.
Read the detailed description
Out of hospital cardiac arrest (OOHCA) remains a leading cause of death in Austria.
Current guidelines recommend to address potentially reversible causes for OOHCA early to improve survival and some of these causes can be recognized using echocardiography. The usefulness of trans-thoracic echocardiography during OOHCA seems to be limited as image acquisition may prolong now flow time and image quality is variable. These limitations might be overcome with trans-esophageal echocardiography.
The investigators will investigate the feasibility of prehospital performed trans-esophageal echocardiography in ten OOHCA patients undergoing advanced life support.
In addition to routine care by paramedics and emergency physicians, a dedicated expert in emergency ultrasound will perform trans-esophageal echocardiography in these patients.
Primary outcome parameter: Is it possible to obtain trans-esophageal images of the heart within 10 minutes after arrival of the study team?
- Being tested
- Transesophageal Echocardiography
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal EchocardiographyDevice
transesophageal Echocardiography during advanced life support
| Study group | Role | What they receive |
|---|---|---|
| Trans-esophageal echocardiography | Experimental | Transesophageal Echocardiography during advanced life support for out of hospital cardiac arrest will be performed. Receives: Device: Transesophageal Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to obtain images of the heart
Time from arrival of the study team on scene, until the following questions are answered by trans esophageal echocardiography: "is spontaneous cardiac movement present", "how ist LV function", "how is RV function", "is a pericardial effusion or tamponade present". The time will be measured in seconds and a maximum of 600 seconds is allowed. If answering the questions within 600 seconds is possible, the case will be counted as "feasible" and the duration of the time measured will be recorded. If answering the questions takes longer than 10 minutes, the case will be counted as "not feasible"
Measured: 10 minutes
Secondary outcomes (4)
Hands off times
what are the "hands off times" (defined as time during which no chest compressions are performed during the resuscitation) during ALS with or without TEE.
Measured: 10 minutes
Hindering of advanced life support measures
The number of events that hinder the established advanced life support measures will be counted graded by severity (minimal, minor, major)
Measured: 10 minutes
Trans esophageal echocardiography related complications
What complications are caused by trans esophageal echocardiography occur during ALS: displacement of the endotracheal tube, dental injury, pharyngeal injury
Measured: 10 minutes
Image quality
How is image quality of trans esophageal echocardiography during advanced life support measures? This will be determined by the investigator performing the trans esophageal echocardiography and also by a blinded specialist afterwards. The rating will be "excellent", "good", "moderate", "poor", "extremely poor"
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start11 Dec 2021
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Echocardiography, TransesophagealStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Berufsrettung Wien
- Responsible party
- Principal investigator, Thomas Hamp, Medical University of Vienna
- Investigators
- Thomas Hamp, M.D., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185596
- Sponsor's protocol ID
- 17182019
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Prehospital Trans Esophageal Echocardiography in Cardiac Arrest
- ClinicalTrials.gov ID
- NCT05185596
- Acronym / sponsor ID
- 17182019
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Berufsrettung Wien
- Study start
- 11 Dec 2021 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 11 Jan 2022 (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.
This study shall investigate the feasibility of prehospital performed trans-esophageal echocardiography in out of hospital cardiac arrest.
The investigators will include ten patients undergoing advanced life support in this study and determine if it is possible to acquire adequate trans-esophageal images within 10 minutes after arrival of the study team on scene.
Detailed description
Out of hospital cardiac arrest (OOHCA) remains a leading cause of death in Austria.
Current guidelines recommend to address potentially reversible causes for OOHCA early to improve survival and some of these causes can be recognized using echocardiography. The usefulness of trans-thoracic echocardiography during OOHCA seems to be limited as image acquisition may prolong now flow time and image quality is variable. These limitations might be overcome with trans-esophageal echocardiography.
The investigators will investigate the feasibility of prehospital performed trans-esophageal echocardiography in ten OOHCA patients undergoing advanced life support.
In addition to routine care by paramedics and emergency physicians, a dedicated expert in emergency ultrasound will perform trans-esophageal echocardiography in these patients.
Primary outcome parameter: Is it possible to obtain trans-esophageal images of the heart within 10 minutes after arrival of the study team?
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trans-esophageal echocardiography | Experimental | Device: Transesophageal EchocardiographyTransesophageal Echocardiography during advanced life support for out of hospital cardiac arrest will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients undergoing advanced life support for out of hospital cardiac arrest
Key exclusion criteria (3 listed)
- patients who should undergo rapid transport to the hospital with ongoing CPR (ECMO candidates, pregnant, trauma, obvious reversible which can be treated in hospital only)
- known esophageal pathology contraindicating TEE
- no definite secure airway present (endotracheal intubation, tracheostomy)
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 |
|---|---|---|
| Transesophageal Echocardiographytransesophageal Echocardiography during advanced life support | Device | Trans-esophageal echocardiography |
Primary outcome
Time to obtain images of the heart
Time frame: 10 minutes
Time from arrival of the study team on scene, until the following questions are answered by trans esophageal echocardiography: "is spontaneous cardiac movement present", "how ist LV function", "how is RV function", "is a pericardial effusion or tamponade present". The time will be measured in seconds and a maximum of 600 seconds is allowed. If answering the questions within 600 seconds is possible, the case will be counted as "feasible" and the duration of the time measured will be recorded. If answering the questions takes longer than 10 minutes, the case will be counted as "not feasible"
4 secondary outcomes
Hands off times
Time frame: 10 minutes
Hindering of advanced life support measures
Time frame: 10 minutes
Trans esophageal echocardiography related complications
Time frame: 10 minutes
Image quality
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Thomas Hamp, M.D. principal investigator
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?
A study testing Transesophageal Echocardiography in people with Echocardiography, Transesophageal and Out-of-Hospital Cardiac Arrest, 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 3 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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Hamp, M.D. (+43140400 ext. 41030, thomas.hamp@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to obtain images of the heart (time frame: 10 minutes). 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 11 Jan 2022.