Out-Of-Hospital Cardiac ArrestAVC in OHCANCT05932784
The Impact of Aortic Valve Compression During Cardio-pulmonary Resuscitation on Patients With Out-of-hospital Cardiac Arrest
An observational study of Out-Of-Hospital Cardiac Arrest, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Purpose: This study aims to find out if the current way of performing chest compressions during resuscitation for patients who have suffered a cardiac arrest outside of the hospital is affecting their chances of recovery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- transesophageal echocardiography
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2020to 1 May 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 20 or older who arrived at the ED with non-traumatic OHCA and underwent TEE during resuscitation were enrolled, except for those meeting the following exclusion criteria: 1) Early ROSC before obtaining TEE image; 2) Insertion of REBOA before ROSC; 3) Initiation of ECMO flow before ROSC; 4) Unidentifiable compression site on TEE; 5) Poor quality TEE image; 6) Missing TEE image
Who may be able to join
- patients aged 20 or older who arrived at the ED with non-traumatic OHCA and underwent TEE during resuscitation
Who cannot join
- Early ROSC before obtaining TEE image;
- Insert the REBOA before ROSC;
- Initiate ECMO flow before ROSC;
- Cannot identify compression site on TEE;
- Poor quality of TEE image;
- Missing TEE image.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Far Eastern Memorial Hospital
Banqiao District, New Taipei City, 220
About this study
Official title: The Impact of Aortic Valve Compression During Cardio-pulmonary Resuscitation on Patients With Out-of-hospital Cardiac Arrest: A Single-center Observational Study Using Transesophageal Echocardiography
Purpose:
This study aims to find out if the current way of performing chest compressions during resuscitation for patients who have suffered a cardiac arrest outside of the hospital is affecting their chances of recovery. Recent research suggests that more than half of these patients receive chest compressions near their aortic valve, which might block blood flow and make their condition worse. We will use a special imaging technique called transesophageal echocardiography (TEE) during resuscitation to see if compressions near the aortic valve impact patient outcomes.
Read more
Methods:
We will conduct a study with patients who have suffered a cardiac arrest outside of the hospital and are receiving TEE during resuscitation in the emergency department. Some patients will not be included in the study, such as those who recover quickly before the TEE is done, those who need other treatments before they recover, those with an unclear compression site, or those with poor or missing TEE images. We will divide the patients into two groups: those with compressions near their aortic valve and those without. We will collect information on the patients, the TEE recordings, the resuscitation process, and important time points. We will mainly look at whether the patients recover and maintain a steady heartbeat. We will also examine other factors like their carbon dioxide levels, whether they recover at all, if they survive to be admitted to the hospital, if they survive to be discharged, and if they have good brain function when they leave the hospital. We plan to have 37 patients in each group for accurate results.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- 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
Also called TEE
Utilizing transesophageal echocardiography (TEE) during resuscitation allows medical professionals to determine if a patient's aortic valve is being compressed while receiving chest compressions, providing valuable insight to optimize the resuscitation process.
| Study group | Role | What they receive |
|---|---|---|
| OHCA patients receiving TEE | Out-of-hospital cardiac arrest (OHCA) patients undergo transesophageal echocardiography (TEE) during resuscitation to determine if their aortic valve is being compressed. Receives: Device: transesophageal echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained return of spontaneous circulation (ROSC)
successful restoration and maintenance of a patient's heartbeat and blood circulation after undergoing cardiopulmonary resuscitation (CPR) for at least 20 minutes
Measured: 20 minutes after ROSC
Secondary outcomes (5)
Any return of spontaneous circulation (ROSC)
Measured: 1 minutes after ROSC
survival to admission
Measured: 48 hours after ROSC
survival to discharge
Measured: 6 months after ROSC
discharge with favorable neurological outcomes
Measured: 6 months after ROSC
end-tidal carbon dioxide (EtCO2)
Measured: During resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Oct 2020
- Primary completion31 Jan 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932784
- Sponsor's protocol ID
- 109070-F-2
- Acronym
- AVC in OHCA
- Status last verified
- Feb 2023
- First submitted
- 27 Jun 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Aortic Valve Compression During Cardio-pulmonary Resuscitation on Patients With Out-of-hospital Cardiac Arrest: A Single-center Observational Study Using Transesophageal Echocardiography
- ClinicalTrials.gov ID
- NCT05932784
- Acronym / sponsor ID
- AVC in OHCA / 109070-F-2
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 6 Jul 2023 (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.
Purpose:
This study aims to find out if the current way of performing chest compressions during resuscitation for patients who have suffered a cardiac arrest outside of the hospital is affecting their chances of recovery. Recent research suggests that more than half of these patients receive chest compressions near their aortic valve, which might block blood flow and make their condition worse. We will use a special imaging technique called transesophageal echocardiography (TEE) during resuscitation to see if compressions near the aortic valve impact patient outcomes.
Methods:
We will conduct a study with patients who have suffered a cardiac arrest outside of the hospital and are receiving TEE during resuscitation in the emergency department. Some patients will not be included in the study, such as those who recover quickly before the TEE is done, those who need other treatments before they recover, those with an unclear compression site, or those with poor or missing TEE images. We will divide the patients into two groups: those with compressions near their aortic valve and those without. We will collect information on the patients, the TEE recordings, the resuscitation process, and important time points. We will mainly look at whether the patients recover and maintain a steady heartbeat. We will also examine other factors like their carbon dioxide levels, whether they recover at all, if they survive to be admitted to the hospital, if they survive to be discharged, and if they have good brain function when they leave the hospital. We plan to have 37 patients in each group for accurate results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OHCA patients receiving TEE | – | Device: transesophageal echocardiographyOut-of-hospital cardiac arrest (OHCA) patients undergo transesophageal echocardiography (TEE) during resuscitation to determine if their aortic valve is being compressed. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 20 or older who arrived at the ED with non-traumatic OHCA and underwent TEE during resuscitation were enrolled, except for those meeting the following exclusion criteria: 1) Early ROSC before obtaining TEE image; 2) Insertion of REBOA before ROSC; 3) Initiation of ECMO flow before ROSC; 4) Unidentifiable compression site on TEE; 5) Poor quality TEE image; 6) Missing TEE image
Key inclusion criteria (1 listed)
- patients aged 20 or older who arrived at the ED with non-traumatic OHCA and underwent TEE during resuscitation
Key exclusion criteria (6 listed)
- Early ROSC before obtaining TEE image;
- Insert the REBOA before ROSC;
- Initiate ECMO flow before ROSC;
- Cannot identify compression site on TEE;
- Poor quality of TEE image;
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 echocardiographyAlso: TEEUtilizing transesophageal echocardiography (TEE) during resuscitation allows medical professionals to determine if a patient's aortic valve is being compressed while receiving chest compressions, providing valuable insight to optimize the resuscitation process. | Device | OHCA patients receiving TEE |
Primary outcome
sustained return of spontaneous circulation (ROSC)
Time frame: 20 minutes after ROSC
successful restoration and maintenance of a patient's heartbeat and blood circulation after undergoing cardiopulmonary resuscitation (CPR) for at least 20 minutes
5 secondary outcomes
Any return of spontaneous circulation (ROSC)
Time frame: 1 minutes after ROSC
survival to admission
Time frame: 48 hours after ROSC
survival to discharge
Time frame: 6 months after ROSC
discharge with favorable neurological outcomes
Time frame: 6 months after ROSC
end-tidal carbon dioxide (EtCO2)
Time frame: During resuscitation
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 6 Jul 2023.
- 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.
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 Out-Of-Hospital Cardiac Arrest, run by Far Eastern Memorial Hospital 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 1 inclusion and 6 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 6 Jul 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 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?
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?
sustained return of spontaneous circulation (ROSC) (time frame: 20 minutes after ROSC). 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 6 Jul 2023.