Out-of-hospital Cardiac Arrest (OHCA)TAPCAPNCT06672315
Application of Transesophageal Echocardiography in Pre-hospital Cardiac Arrest Patients
A study testing transesophageal echocardiography in people with Out-of-hospital Cardiac Arrest (OHCA), run by Jen-Tang Sun at 1 site in Taiwan.
Trial summary
The Use of Point-of-Care Ultrasound (POCUS), Transthoracic Echocardiography (TTE), and Transesophageal Echocardiography (TEE) in Cardiac Arrest and Acute Coronary Syndrome Patients Studies have shown that POCUS can rapidly change the management in nearly 80% of cases in emergency settings, particularly in environments… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-hospital Cardiac Arrest (OHCA)
- What is being tested?
- transesophageal echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Dec 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Patients with out-of-hospital cardiac arrest (OHCA)
- Non-traumatic cause of cardiac arrest
Who cannot join
- Presence of obvious signs of death, such as decapitation, rigor mortis, livor mortis, or decomposition.
- Family explicitly expresses a Do Not Attempt Resuscitation (DNR) order, or the patient has a documented refusal of resuscitation.
- Any condition that contraindicates the use of transesophageal echocardiography (TEE), such as esophageal tumors, preventing probe insertion.
- Patients eligible for ECPR (Extracorporeal Cardiopulmonary Resuscitation) treatment.
- Spontaneous circulation has already been stabilized before performing TEE.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorinal Hospital and New Taipei City fire department
New Taipei City, 220
Chiao-Yin Cheng Cheng, +886 2 7728 1843, femhresearch@gmail.com
About this study
Official title: Transesophageal Echocardiography in Pre-hospital Cardiac Arrest Patients; TAPCAP
The Use of Point-of-Care Ultrasound (POCUS), Transthoracic Echocardiography (TTE), and Transesophageal Echocardiography (TEE) in Cardiac Arrest and Acute Coronary Syndrome Patients
Studies have shown that POCUS can rapidly change the management in nearly 80% of cases in emergency settings, particularly in environments such as war zones and disaster relief. TTE is highly sensitive in diagnosing acute coronary syndromes and can effectively rule out myocardial infarction. In cardiac arrest patients, TTE assists in determining cardiac activity and identifying reversible causes, such as pericardial tamponade and pneumothorax. However, TTE can be affected by suboptimal image quality due to factors like chest compression in out-of-hospital cardiac arrest (OHCA) patients.
Read more
In Taiwan's emergency medical system, EMT-Ps (paramedics) undergo approximately one year of training, which enables them to provide emergency care, including ultrasound examinations, before hospital arrival. Research on pre-hospital cardiac arrest has shown that most ultrasound applications can be completed within 3 minutes and do not significantly increase on-scene time.
TEE, though advantageous for its high-quality imaging and ability to reduce interruptions during chest compressions, faces challenges in pre-hospital emergency applications due to specialized training and equipment requirements. However, a study in Vienna, Austria, demonstrated that TEE could be performed and yield high-quality images in most pre-hospital cases, with an average examination time of 5.1 minutes.
Several hospitals in Taiwan have begun training personnel in TEE, emphasizing the importance of establishing TEE image registries for large-scale, effective research analysis. However, these efforts also face challenges related to resources and collaboration. The research team has over three years of experience using TEE in the emergency department to examine OHCA patients, and a three-year study will be conducted to validate the efficacy of pre-hospital TEE in cardiac arrest patients.
Read the detailed description
Background:
The application of Point-of-Care Ultrasound (POCUS), Transthoracic Echocardiography (TTE), and Transesophageal Echocardiography (TEE) in cardiac arrest and acute coronary syndrome has evolved with technological advancements. POCUS, in particular, has been recognized for its ability to change clinical management in nearly 80% of emergency cases, such as war and disaster scenarios. TTE is highly sensitive in diagnosing acute coronary syndromes and can effectively rule out myocardial infarction. It also plays a crucial role in identifying reversible causes in cardiac arrest patients, like pericardial tamponade and pneumothorax, but its image quality can be compromised during chest compressions in out-of-hospital cardiac arrest (OHCA) patients. TEE, on the other hand, offers superior image quality and reduces interruptions during chest compressions but requires specialized training and equipment.
Currently, Taiwan\'s emergency medical system allows EMT-P personnel, after a year of training, to perform pre-hospital ultrasounds, including POCUS, for OHCA patients. Research has shown that most ultrasound applications can be completed in under 3 minutes without significantly increasing on-scene time. TEE\'s use in pre-hospital emergencies has also been validated in international studies, such as those from Vienna, which demonstrated TEE\'s feasibility in providing clear diagnostic images during pre-hospital cardiac arrest care.
Research Methods:
This study aims to assess the feasibility and efficacy of TEE in pre-hospital cardiac arrest care through a randomized controlled trial over three years.
Study Design:
The study will be conducted in two phases:
Phase 1: A prospective observational feasibility study involving 60 patients to assess the practical application of TEE in pre-hospital settings.
Patients aged 18 or older. Non-traumatic OHCA patients.
Exclusion Criteria:
Signs of obvious death. Patients with DNR orders. Patients for whom TEE is contraindicated (e.g., esophageal tumors). Patients requiring ECPR.
Training and Implementation:
Emergency department staff and EMT teams will undergo specialized training, including TEE workshops and simulations. The TEE procedure will be performed after establishing the airway and during mechanical chest compressions using a LUCAS device.
Data Collection:
Data will include patient demographics, emergency response times, CPR parameters, and TEE imaging results. Outcomes such as return of spontaneous circulation (ROSC) and neurological recovery will be tracked.
Randomization:
The RCT phase will utilize cluster randomization based on bi-weekly intervals, ensuring random and balanced patient groupings for intervention and control.
Sample Size Estimation:
Based on prior studies and statistical analysis, each group will require 93 patients to detect significant differences, with a total of 186 patients over the course of 24 months.
Expected Results:
The study anticipates that the use of TEE in pre-hospital cardiac arrest care will:
Provide high-quality cardiac images during CPR. Facilitate accurate identification of reversible causes of cardiac arrest. Improve the overall effectiveness of CPR through real-time feedback. Demonstrate the feasibility of integrating TEE into pre-hospital emergency protocols without significantly delaying patient transport.
The primary outcome is the proportion of cases where TEE ensures optimal chest compression. Secondary outcomes include the rate of sustained ROSC, time to ROSC, and neurological outcomes.
Conclusion:
This study will provide valuable insights into the feasibility and impact of TEE in pre-hospital cardiac arrest management. It will serve as the foundation for future large-scale research and contribute to improving survival rates and neurological outcomes in OHCA patients.
- Conditions
- Out-of-hospital Cardiac Arrest (OHCA)
- Being tested
- transesophageal echocardiography
- Keywords
- Left Ventricular Outflow Tract, Transesophageal Echocardiography, TEE, LVOT, OHCA
- 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 echocardiographyDiagnostic test
Confirmation of chest compression positioning via transesophageal echocardiography (TEE)
| Study group | Role | What they receive |
|---|---|---|
| Performing TEE | Experimental | In this group of patients, transesophageal echocardiography (TEE) will be performed to confirm optimal chest compression positioning while utilizing a mechanical chest compression device. Receives: Diagnostic Test: transesophageal echocardiography |
| not performing TEE | No intervention | In this group of patients, transesophageal echocardiography (TEE) will not be performed, and the mechanical chest compression device will be positioned at the intersection of the nipple line and the sternum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using TEE to assist OHCA patients in pre-hospital emergency treatment
Feasibility of using TEE to assist OHCA patients in pre-hospital emergency treatment. The proportion of successfully ensuring LV compression during prehospital CPR.
Measured: 30 days after cardiac arrest or upon the patient's death, whichever came first
Secondary outcomes (5)
Sustained return of spontaneous circulation (sustained ROSC) lasting approximately 20 minutes
Measured: Patient sustained ROSC for 20 minutes after
Time from the start of resuscitation to the first return of spontaneous circulation (ROSC)
Time from the start of resuscitation to the first return of spontaneous circulation (ROSC)
Measured: 1 minute after patient first ROSC
Any ROSC rate
Any ROSC rate
Measured: 1 minute after patient ROSC
Favorable neurologic outcome with discharge to home (Cerebral Performance Category 1 or 2)
Record the patient's neurological outcome at the time of discharge
Measured: Up to 6 months after discharge date
End-tidal carbon dioxide (EtCO2)
End-tidal carbon dioxide (EtCO2) values during the resuscitation process.
Measured: One hour after arriving at the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start30 Dec 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Out-of-hospital Cardiac Arrest (OHCA)Studies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients aged 18 years or older who have experienced out-of-hospital cardiac arrest (OHCA) due to non-traumatic causes
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jen-Tang Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jen-Tang Sun, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672315
- Sponsor's protocol ID
- 113027-F
- Acronym
- TAPCAP
- Status last verified
- Mar 2025
- First submitted
- 30 Sep 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Name and email
Publications
Krammel M, Hamp T, Hafner C, Magnet I, Poppe M, Marhofer P. Feasibility of resuscitative transesophageal echocardiography at out-of-hospital emergency scenes of cardiac arrest. Sci Rep. 2023 Nov 16;13(1):20085. doi: 10.1038/s41598-023-46684-x.
PubMed 37973909Hermann 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 35331304Reed MJ, Gibson L, Dewar A, Short S, Black P, Clegg GR. Introduction of paramedic led Echo in Life Support into the pre-hospital environment: The PUCA study. Resuscitation. 2017 Mar;112:65-69. doi: 10.1016/j.resuscitation.2016.09.003. Epub 2016 Sep 13.
PubMed 27638418Botker MT, Vang ML, Grofte T, Kirkegaard H, Frederiksen CA, Sloth E. Implementing point-of-care ultrasonography of the heart and lungs in an anesthesia department. Acta Anaesthesiol Scand. 2017 Feb;61(2):156-165. doi: 10.1111/aas.12847.
PubMed 28066904Clattenburg EJ, Wroe P, Brown S, Gardner K, Losonczy L, Singh A, Nagdev A. Point-of-care ultrasound use in patients with cardiac arrest is associated prolonged cardiopulmonary resuscitation pauses: A prospective cohort study. Resuscitation. 2018 Jan;122:65-68. doi: 10.1016/j.resuscitation.2017.11.056. Epub 2017 Nov 23.
PubMed 29175356Huis In 't Veld MA, Allison MG, Bostick DS, Fisher KR, Goloubeva OG, Witting MD, Winters ME. Ultrasound use during cardiopulmonary resuscitation is associated with delays in chest compressions. Resuscitation. 2017 Oct;119:95-98. doi: 10.1016/j.resuscitation.2017.07.021. Epub 2017 Jul 25.
PubMed 28754527El Sayed MJ, Zaghrini E. Prehospital emergency ultrasound: a review of current clinical applications, challenges, and future implications. Emerg Med Int. 2013;2013:531674. doi: 10.1155/2013/531674. Epub 2013 Sep 19.
PubMed 24171113Chin EJ, Chan CH, Mortazavi R, Anderson CL, Kahn CA, Summers S, Fox JC. A pilot study examining the viability of a Prehospital Assessment with UltraSound for Emergencies (PAUSE) protocol. J Emerg Med. 2013 Jan;44(1):142-9. doi: 10.1016/j.jemermed.2012.02.032. Epub 2012 May 16.
PubMed 22595631Hussein L, Rehman MA, Jelic T, Berdnikov A, Teran F, Richards S, Askin N, Jarman R; SHoC Investigators and the Resuscitative TEE Collaborative Registry Investigators. Transoesophageal echocardiography in cardiac arrest: A systematic review. Resuscitation. 2021 Nov;168:167-175. doi: 10.1016/j.resuscitation.2021.08.001. Epub 2021 Aug 12.
PubMed 34390824Breitkreutz R, Price S, Steiger HV, Seeger FH, Ilper H, Ackermann H, Rudolph M, Uddin S, Weigand MA, Muller E, Walcher F; Emergency Ultrasound Working Group of the Johann Wolfgang Goethe-University Hospital, Frankfurt am Main. Focused echocardiographic evaluation in life support and peri-resuscitation of emergency patients: a prospective trial. Resuscitation. 2010 Nov;81(11):1527-33. doi: 10.1016/j.resuscitation.2010.07.013.
PubMed 20801576Hayhurst C, Lebus C, Atkinson PR, Kendall R, Madan R, Talbot J, Ross P, Lewis D. An evaluation of echo in life support (ELS): is it feasible? What does it add? Emerg Med J. 2011 Feb;28(2):119-21. doi: 10.1136/emj.2009.084202. Epub 2010 Oct 4.
PubMed 20921017Long B, Alerhand S, Maliel K, Koyfman A. Echocardiography in cardiac arrest: An emergency medicine review. Am J Emerg Med. 2018 Mar;36(3):488-493. doi: 10.1016/j.ajem.2017.12.031. Epub 2017 Dec 16.
PubMed 29269162Rybicki FJ, Udelson JE, Peacock WF, Goldhaber SZ, Isselbacher EM, Kazerooni E, Kontos MC, Litt H, Woodard PK. 2015 ACR/ACC/AHA/AATS/ACEP/ASNC/NASCI/SAEM/SCCT/SCMR/SCPC/SNMMI/STR/STS Appropriate Utilization of Cardiovascular Imaging in Emergency Department Patients With Chest Pain: A Joint Document of the American College of Radiology Appropriateness Criteria Committee and the American College of Cardiology Appropriate Use Criteria Task Force. J Am Coll Cardiol. 2016 Feb 23;67(7):853-79. doi: 10.1016/j.jacc.2015.09.011. Epub 2016 Jan 22. No abstract available.
PubMed 26809772Atkinson P, Bowra J, Milne J, Lewis D, Lambert M, Jarman B, Noble VE, Lamprecht H, Harris T, Connolly J; and members of the International Federation of Emergency Medicine Sonography in Hypotension and Cardiac Arrest working group: Romolo Gaspari, MD, PhD; Ross Kessler, MD; Christopher Raio, MD; Paul Sierzenski, MD; Beatrice Hoffmann, MD; Chau Pham, MD; Michael Woo, MD; Paul Olszynski, MD; Ryan Henneberry, MD; Oron Frenkel, MD; Jordan Chenkin, MD; Greg Hall, MD; Louise Rang, MD; Maxime Valois, MD; Chuck Wurster, MD; Mark Tutschka, MD; Rob Arntfield, MD; Jason Fischer, MD; Mark Tessaro, MD; J. Scott Bomann, DO; Adrian Goudie, MB; Gaby Blecher, MB; Andree Salter, MB; Michael Rose, MB; Adam Bystrzycki, MB; Shailesh Dass, MB; Owen Doran, MB; Ruth Large, MB; Hugo Poncia, MB; Alistair Murray, MB; Jan Sadewasser, MD; Raoul Breitkreutz, MD; Hong Chuen Toh, MB; Arif Alper Cevik, MD; Ang Shiang Hu, MB; Larry Melniker, MD, MS. International Federation for Emergency Medicine Consensus Statement: Sonography in hypotension and cardiac arrest (SHoC): An international consensus on the use of point of care ultrasound for undifferentiated hypotension and during cardiac arrest. CJEM. 2017 Nov;19(6):459-470. doi: 10.1017/cem.2016.394. Epub 2016 Dec 21.
PubMed 27998322Leonardi M, Condous G. A pictorial guide to the ultrasound identification and assessment of uterosacral ligaments in women with potential endometriosis. Australas J Ultrasound Med. 2019 Aug 9;22(3):157-164. doi: 10.1002/ajum.12178. eCollection 2019 Aug.
PubMed 34760552
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transesophageal Echocardiography in Pre-hospital Cardiac Arrest Patients; TAPCAP
- ClinicalTrials.gov ID
- NCT06672315
- Acronym / sponsor ID
- TAPCAP / 113027-F
- Conditions
- Out-of-hospital Cardiac Arrest (OHCA)
- Keywords
- Left Ventricular Outflow Tract, Transesophageal Echocardiography, TEE, LVOT, OHCA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jen-Tang SunUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 4 Nov 2024 (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.
The Use of Point-of-Care Ultrasound (POCUS), Transthoracic Echocardiography (TTE), and Transesophageal Echocardiography (TEE) in Cardiac Arrest and Acute Coronary Syndrome Patients
Studies have shown that POCUS can rapidly change the management in nearly 80% of cases in emergency settings, particularly in environments such as war zones and disaster relief. TTE is highly sensitive in diagnosing acute coronary syndromes and can effectively rule out myocardial infarction. In cardiac arrest patients, TTE assists in determining cardiac activity and identifying reversible causes, such as pericardial tamponade and pneumothorax. However, TTE can be affected by suboptimal image quality due to factors like chest compression in out-of-hospital cardiac arrest (OHCA) patients.
In Taiwan's emergency medical system, EMT-Ps (paramedics) undergo approximately one year of training, which enables them to provide emergency care, including ultrasound examinations, before hospital arrival. Research on pre-hospital cardiac arrest has shown that most ultrasound applications can be completed within 3 minutes and do not significantly increase on-scene time.
TEE, though advantageous for its high-quality imaging and ability to reduce interruptions during chest compressions, faces challenges in pre-hospital emergency applications due to specialized training and equipment requirements. However, a study in Vienna, Austria, demonstrated that TEE could be performed and yield high-quality images in most pre-hospital cases, with an average examination time of 5.1 minutes.
Several hospitals in Taiwan have begun training personnel in TEE, emphasizing the importance of establishing TEE image registries for large-scale, effective research analysis. However, these efforts also face challenges related to resources and collaboration. The research team has over three years of experience using TEE in the emergency department to examine OHCA patients, and a three-year study will be conducted to validate the efficacy of pre-hospital TEE in cardiac arrest patients.
Detailed description
Background:
The application of Point-of-Care Ultrasound (POCUS), Transthoracic Echocardiography (TTE), and Transesophageal Echocardiography (TEE) in cardiac arrest and acute coronary syndrome has evolved with technological advancements. POCUS, in particular, has been recognized for its ability to change clinical management in nearly 80% of emergency cases, such as war and disaster scenarios. TTE is highly sensitive in diagnosing acute coronary syndromes and can effectively rule out myocardial infarction. It also plays a crucial role in identifying reversible causes in cardiac arrest patients, like pericardial tamponade and pneumothorax, but its image quality can be compromised during chest compressions in out-of-hospital cardiac arrest (OHCA) patients. TEE, on the other hand, offers superior image quality and reduces interruptions during chest compressions but requires specialized training and equipment.
Currently, Taiwan\'s emergency medical system allows EMT-P personnel, after a year of training, to perform pre-hospital ultrasounds, including POCUS, for OHCA patients. Research has shown that most ultrasound applications can be completed in under 3 minutes without significantly increasing on-scene time. TEE\'s use in pre-hospital emergencies has also been validated in international studies, such as those from Vienna, which demonstrated TEE\'s feasibility in providing clear diagnostic images during pre-hospital cardiac arrest care.
Research Methods:
This study aims to assess the feasibility and efficacy of TEE in pre-hospital cardiac arrest care through a randomized controlled trial over three years.
Study Design:
The study will be conducted in two phases:
Phase 1: A prospective observational feasibility study involving 60 patients to assess the practical application of TEE in pre-hospital settings.
Patients aged 18 or older. Non-traumatic OHCA patients.
Exclusion Criteria:
Signs of obvious death. Patients with DNR orders. Patients for whom TEE is contraindicated (e.g., esophageal tumors). Patients requiring ECPR.
Training and Implementation:
Emergency department staff and EMT teams will undergo specialized training, including TEE workshops and simulations. The TEE procedure will be performed after establishing the airway and during mechanical chest compressions using a LUCAS device.
Data Collection:
Data will include patient demographics, emergency response times, CPR parameters, and TEE imaging results. Outcomes such as return of spontaneous circulation (ROSC) and neurological recovery will be tracked.
Randomization:
The RCT phase will utilize cluster randomization based on bi-weekly intervals, ensuring random and balanced patient groupings for intervention and control.
Sample Size Estimation:
Based on prior studies and statistical analysis, each group will require 93 patients to detect significant differences, with a total of 186 patients over the course of 24 months.
Expected Results:
The study anticipates that the use of TEE in pre-hospital cardiac arrest care will:
Provide high-quality cardiac images during CPR. Facilitate accurate identification of reversible causes of cardiac arrest. Improve the overall effectiveness of CPR through real-time feedback. Demonstrate the feasibility of integrating TEE into pre-hospital emergency protocols without significantly delaying patient transport.
The primary outcome is the proportion of cases where TEE ensures optimal chest compression. Secondary outcomes include the rate of sustained ROSC, time to ROSC, and neurological outcomes.
Conclusion:
This study will provide valuable insights into the feasibility and impact of TEE in pre-hospital cardiac arrest management. It will serve as the foundation for future large-scale research and contribute to improving survival rates and neurological outcomes in OHCA patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients aged 18 years or older who have experienced out-of-hospital cardiac arrest (OHCA) due to non-traumatic causes
| Arm | Type | Receives |
|---|---|---|
| Performing TEE | Experimental | Diagnostic Test: transesophageal echocardiographyIn this group of patients, transesophageal echocardiography (TEE) will be performed to confirm optimal chest compression positioning while utilizing a mechanical chest compression device. |
| not performing TEE | No intervention | –In this group of patients, transesophageal echocardiography (TEE) will not be performed, and the mechanical chest compression device will be positioned at the intersection of the nipple line and the sternum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients with out-of-hospital cardiac arrest (OHCA)
- Non-traumatic cause of cardiac arrest
Key exclusion criteria (5 listed)
- Presence of obvious signs of death, such as decapitation, rigor mortis, livor mortis, or decomposition.
- Family explicitly expresses a Do Not Attempt Resuscitation (DNR) order, or the patient has a documented refusal of resuscitation.
- Any condition that contraindicates the use of transesophageal echocardiography (TEE), such as esophageal tumors, preventing probe insertion.
- Patients eligible for ECPR (Extracorporeal Cardiopulmonary Resuscitation) treatment.
- Spontaneous circulation has already been stabilized before performing TEE.
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 echocardiographyConfirmation of chest compression positioning via transesophageal echocardiography (TEE) | Diagnostic test | Performing TEE |
Primary outcome
Feasibility of using TEE to assist OHCA patients in pre-hospital emergency treatment
Time frame: 30 days after cardiac arrest or upon the patient's death, whichever came first
Feasibility of using TEE to assist OHCA patients in pre-hospital emergency treatment. The proportion of successfully ensuring LV compression during prehospital CPR.
5 secondary outcomes
Sustained return of spontaneous circulation (sustained ROSC) lasting approximately 20 minutes
Time frame: Patient sustained ROSC for 20 minutes after
Time from the start of resuscitation to the first return of spontaneous circulation (ROSC)
Time frame: 1 minute after patient first ROSC
Any ROSC rate
Time frame: 1 minute after patient ROSC
Favorable neurologic outcome with discharge to home (Cerebral Performance Category 1 or 2)
Time frame: Up to 6 months after discharge date
End-tidal carbon dioxide (EtCO2)
Time frame: One hour after arriving at the hospital
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Results publication: PubMed 37973909Krammel M, Hamp T, Hafner C, Magnet I, Poppe M, Marhofer P. Feasibility of resuscitative transesophageal echocardiography at out-of-hospital emergency scenes of cardiac arrest. Sci Rep. 2023 Nov 16;13(1):20085. doi: 10.1038/s41598-023-46684-x.
- Results publication: 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.
- Results publication: PubMed 27638418Reed MJ, Gibson L, Dewar A, Short S, Black P, Clegg GR. Introduction of paramedic led Echo in Life Support into the pre-hospital environment: The PUCA study. Resuscitation. 2017 Mar;112:65-69. doi: 10.1016/j.resuscitation.2016.09.003. Epub 2016 Sep 13.
- Results publication: PubMed 28066904Botker MT, Vang ML, Grofte T, Kirkegaard H, Frederiksen CA, Sloth E. Implementing point-of-care ultrasonography of the heart and lungs in an anesthesia department. Acta Anaesthesiol Scand. 2017 Feb;61(2):156-165. doi: 10.1111/aas.12847.
- Results publication: PubMed 29175356Clattenburg EJ, Wroe P, Brown S, Gardner K, Losonczy L, Singh A, Nagdev A. Point-of-care ultrasound use in patients with cardiac arrest is associated prolonged cardiopulmonary resuscitation pauses: A prospective cohort study. Resuscitation. 2018 Jan;122:65-68. doi: 10.1016/j.resuscitation.2017.11.056. Epub 2017 Nov 23.
- Results publication: PubMed 28754527Huis In 't Veld MA, Allison MG, Bostick DS, Fisher KR, Goloubeva OG, Witting MD, Winters ME. Ultrasound use during cardiopulmonary resuscitation is associated with delays in chest compressions. Resuscitation. 2017 Oct;119:95-98. doi: 10.1016/j.resuscitation.2017.07.021. Epub 2017 Jul 25.
- Results publication: PubMed 24171113El Sayed MJ, Zaghrini E. Prehospital emergency ultrasound: a review of current clinical applications, challenges, and future implications. Emerg Med Int. 2013;2013:531674. doi: 10.1155/2013/531674. Epub 2013 Sep 19.
- Results publication: PubMed 22595631Chin EJ, Chan CH, Mortazavi R, Anderson CL, Kahn CA, Summers S, Fox JC. A pilot study examining the viability of a Prehospital Assessment with UltraSound for Emergencies (PAUSE) protocol. J Emerg Med. 2013 Jan;44(1):142-9. doi: 10.1016/j.jemermed.2012.02.032. Epub 2012 May 16.
- Results publication: PubMed 34390824Hussein L, Rehman MA, Jelic T, Berdnikov A, Teran F, Richards S, Askin N, Jarman R; SHoC Investigators and the Resuscitative TEE Collaborative Registry Investigators. Transoesophageal echocardiography in cardiac arrest: A systematic review. Resuscitation. 2021 Nov;168:167-175. doi: 10.1016/j.resuscitation.2021.08.001. Epub 2021 Aug 12.
- Results publication: PubMed 20801576Breitkreutz R, Price S, Steiger HV, Seeger FH, Ilper H, Ackermann H, Rudolph M, Uddin S, Weigand MA, Muller E, Walcher F; Emergency Ultrasound Working Group of the Johann Wolfgang Goethe-University Hospital, Frankfurt am Main. Focused echocardiographic evaluation in life support and peri-resuscitation of emergency patients: a prospective trial. Resuscitation. 2010 Nov;81(11):1527-33. doi: 10.1016/j.resuscitation.2010.07.013.
- Results publication: PubMed 20921017Hayhurst C, Lebus C, Atkinson PR, Kendall R, Madan R, Talbot J, Ross P, Lewis D. An evaluation of echo in life support (ELS): is it feasible? What does it add? Emerg Med J. 2011 Feb;28(2):119-21. doi: 10.1136/emj.2009.084202. Epub 2010 Oct 4.
- Results publication: PubMed 29269162Long B, Alerhand S, Maliel K, Koyfman A. Echocardiography in cardiac arrest: An emergency medicine review. Am J Emerg Med. 2018 Mar;36(3):488-493. doi: 10.1016/j.ajem.2017.12.031. Epub 2017 Dec 16.
- Individual participant dataSharing planned: Yes. Name and email
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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.
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 Out-of-hospital Cardiac Arrest (OHCA), run by Jen-Tang Sun at 1 site in Taiwan.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Mar 2025. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jen-Tang Sun (+886 2 77281843, femhresearch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of using TEE to assist OHCA patients in pre-hospital emergency treatment (time frame: 30 days after cardiac arrest or upon the patient's death, whichever came first). 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 NCT06672315, which also lists 18 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 5 Mar 2025.