Out-Of-Hospital Cardiac ArrestNCT06012838
The Systematic Approach for Identification of Cause Among Out-of-hospital Cardiac Arrest Survivors
A study testing Cause classification of OHCA protocol in people with Out-Of-Hospital Cardiac Arrest, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The cause of cardiac arrest mostly determines outcomes of cardiac arrest survivors. Identifying and treating the cause of cardiac arrest constitute a critical part in post-arrest care. However, the pathophysiology of cardiac arrest often encompasses multiple organ systems. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Cause classification of OHCA protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Aug 2022to 10 Nov 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Residents of National Taiwan University Hospital
Who cannot join
- Visiting staffs of National Taiwan University Hospital
Trial locations and contacts
1 site in 1 country.
About this study
The cause of cardiac arrest mostly determines outcomes of cardiac arrest survivors. Identifying and treating the cause of cardiac arrest constitute a critical part in post-arrest care. However, the pathophysiology of cardiac arrest often encompasses multiple organ systems. Thus, forming accurate diagnosis for each case presents a daunting challenge, especially for unexperienced physicians. This study aims to evaluate whether a standardized protocol would improve the diagnostic proficiency for out-of-hospital cardiac arrest (OHCA) patients.
Sixteen Emergency Medicine Residents from National Taiwan University Hospital participated in this study. The cause classification of OHCA (CCCA) protocol was developed by an expert cardiac arrest committee, and a lecture concerning the Utstein's template, the epidemiology of cardiac arrest and the CCCA protocol was addressed. Pre-/post-lecture questionnaires regarding self-assessed diagnostic certainty and knowledge of cardiac arrest were obtained and compared to evaluate participants' learning effectiveness. To validate the efficiency of protocol, medical records of 586 non-traumatic OHCA adults with successful resuscitation and ICU admission were reviewed retrospectively, and the OHCA cause of each patient was identified by the trained residents following CCCA protocol. The primary outcome was the diagnostic consistency between protocolized diagnosis, expert diagnosis and the discharge diagnosis
Read the detailed description
To identify the classification of OHCA cause, the cause classification of OHCA (CCCA) protocol was established based on previous studies, expert physician's experience and questionnaire of young physicians.
Residents from emergency department of National Taiwan University Hospital participated the program and received the lecture concerning the Utstein's template, the epidemiology of cardiac arrest, interpretation of examinations, and the CCCA protocol. To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed, which included the knowledge for OHCA classification, confidence for correct diagnosis during CPR and after return of spontaneous circulation (ROSC), and the mandatory examinations for cause identification. Confidence level more than 50% was recognized as sufficient to make proper cause identification. The enrolled residents were asked to review the medical records of 3 non-traumatic adult OHCA patients before lecture and identified the OHCA cause by their own without the assist of the CCCA protocol. After lecture, another 3 medical records were reviewed by the participants with the use of the CCAC protocol. The consistency of OHCA cause between young physicians were evaluated before and after lecture, respectively.
To validate the efficiency of the CCCA protocol, these trained residents further identified the arrest cause of 586 non-traumatic adult OHCA patients who survived to ICU admission from January 2015 to July 2021 in NTUH following the established protocol.
The primary outcome was the consistency of OHCA cause between protocolized diagnosis, expert diagnosis and the discharge diagnosis. The diagnosis made by young physicians with protocol defined as protocolized diagnosis. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. Expert diagnosis was recognized as diagnosis identified by expert physician. The discharge diagnosis is the major diagnosis related to index cardiac arrest.
Categorical variables are presented as numbers (percentages) and evaluated by the Chi-Squared test. The continuous variables are presented as mean ± standard deviation. The Light's kappa was used to evaluate the consistency of OHCA classification. The value ≤ 0.40 indicates minimal agreement, while value ≥ 0.80 represent strong and almost perfect consistency16-17. The statistical significance was set at p <0.05. All statistical analyses were performed using Statistical Package for Social Sciences Statistics (version 21.0; IBM, Chicago, IL, USA).
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Cause classification of OHCA protocol
- Keywords
- Non-traumatic Out-Of-Hospital Cardiac Arrest, training program
- 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.
Cause classification of OHCA protocolBehavioural
training program with cause classification of OHCA protocol
| Study group | Role | What they receive |
|---|---|---|
| cause classification of OHCA protocol | Experimental | The cause classification of OHCA protocol was developed by an expert cardiac arrest committee. A lecture concerning the Utstein's template, the epidemiology of cardiac arrest and the CCCA protocol was addressed to the participants. Receives: Behavioral: Cause classification of OHCA protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic consistency between protocolized diagnosis and the discharge diagnosis
The diagnosis made by young physicians with protocol defined as protocolized diagnosis. Expert diagnosis was recognized as diagnosis identified by expert physician. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. The discharge diagnosis is the major diagnosis related to index cardiac arrest. The Light's kappa was used to evaluate the consistency of OHCA classification.
Measured: 3 months
diagnostic consistency between protocolized diagnosis and the expert diagnosis
The diagnosis made by young physicians with protocol defined as protocolized diagnosis. Expert diagnosis was recognized as diagnosis identified by expert physician. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. The discharge diagnosis is the major diagnosis related to index cardiac arrest. The Light's kappa was used to evaluate the consistency of OHCA classification.
Measured: 3 months
Secondary outcomes (3)
Portion of sufficient confidence to make proper OHCA cause identification
To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed. Confidence level more than 50% was recognized as sufficient to make proper cause identification. Categorical variables are presented as numbers (percentages) and evaluated by the Chi-Squared test.
Measured: 2 months
the accuracy rates on the classification test of OHCA cause before and after the lecture
To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed. The knowledge for OHCA classification was evaluated by the accuracy rates on each questionnaires. Categorical variables are presented as numbers (percentages) and evaluated by the Chi-Squared test.
Measured: baseline, 2 weeks
diagnostic consistency between participants before and after the lecture
To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed. The enrolled residents were asked to review the medical records of 3 non-traumatic adult OHCA patients before lecture and identified the OHCA cause by their own without the assist of the CCCA protocol. After lecture, another 3 medical records were reviewed by the participants with the use of the CCAC protocol. The consistency of OHCA cause between young physicians were evaluated before and after lecture, respectively. The Light's kappa was used to evaluate the consistency of OHCA classification.
Measured: baseline, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start10 Aug 2022
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
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.
- More trials run by National Taiwan University HospitalThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min-Shan Tsai, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012838
- Sponsor's protocol ID
- 202207125RIND
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Systematic Approach for Identification of Cause Among Out-of-hospital Cardiac Arrest Survivors
- ClinicalTrials.gov ID
- NCT06012838
- Acronym / sponsor ID
- 202207125RIND
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Non-traumatic Out-Of-Hospital Cardiac Arrest, training program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 28 Aug 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.
The cause of cardiac arrest mostly determines outcomes of cardiac arrest survivors. Identifying and treating the cause of cardiac arrest constitute a critical part in post-arrest care. However, the pathophysiology of cardiac arrest often encompasses multiple organ systems. Thus, forming accurate diagnosis for each case presents a daunting challenge, especially for unexperienced physicians. This study aims to evaluate whether a standardized protocol would improve the diagnostic proficiency for out-of-hospital cardiac arrest (OHCA) patients.
Sixteen Emergency Medicine Residents from National Taiwan University Hospital participated in this study. The cause classification of OHCA (CCCA) protocol was developed by an expert cardiac arrest committee, and a lecture concerning the Utstein's template, the epidemiology of cardiac arrest and the CCCA protocol was addressed. Pre-/post-lecture questionnaires regarding self-assessed diagnostic certainty and knowledge of cardiac arrest were obtained and compared to evaluate participants' learning effectiveness. To validate the efficiency of protocol, medical records of 586 non-traumatic OHCA adults with successful resuscitation and ICU admission were reviewed retrospectively, and the OHCA cause of each patient was identified by the trained residents following CCCA protocol. The primary outcome was the diagnostic consistency between protocolized diagnosis, expert diagnosis and the discharge diagnosis
Detailed description
To identify the classification of OHCA cause, the cause classification of OHCA (CCCA) protocol was established based on previous studies, expert physician's experience and questionnaire of young physicians.
Residents from emergency department of National Taiwan University Hospital participated the program and received the lecture concerning the Utstein's template, the epidemiology of cardiac arrest, interpretation of examinations, and the CCCA protocol. To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed, which included the knowledge for OHCA classification, confidence for correct diagnosis during CPR and after return of spontaneous circulation (ROSC), and the mandatory examinations for cause identification. Confidence level more than 50% was recognized as sufficient to make proper cause identification. The enrolled residents were asked to review the medical records of 3 non-traumatic adult OHCA patients before lecture and identified the OHCA cause by their own without the assist of the CCCA protocol. After lecture, another 3 medical records were reviewed by the participants with the use of the CCAC protocol. The consistency of OHCA cause between young physicians were evaluated before and after lecture, respectively.
To validate the efficiency of the CCCA protocol, these trained residents further identified the arrest cause of 586 non-traumatic adult OHCA patients who survived to ICU admission from January 2015 to July 2021 in NTUH following the established protocol.
The primary outcome was the consistency of OHCA cause between protocolized diagnosis, expert diagnosis and the discharge diagnosis. The diagnosis made by young physicians with protocol defined as protocolized diagnosis. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. Expert diagnosis was recognized as diagnosis identified by expert physician. The discharge diagnosis is the major diagnosis related to index cardiac arrest.
Categorical variables are presented as numbers (percentages) and evaluated by the Chi-Squared test. The continuous variables are presented as mean ± standard deviation. The Light's kappa was used to evaluate the consistency of OHCA classification. The value ≤ 0.40 indicates minimal agreement, while value ≥ 0.80 represent strong and almost perfect consistency16-17. The statistical significance was set at p <0.05. All statistical analyses were performed using Statistical Package for Social Sciences Statistics (version 21.0; IBM, Chicago, IL, USA).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cause classification of OHCA protocol | Experimental | Behavioral: Cause classification of OHCA protocolThe cause classification of OHCA protocol was developed by an expert cardiac arrest committee. A lecture concerning the Utstein's template, the epidemiology of cardiac arrest and the CCCA protocol was addressed to the participants. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Residents of National Taiwan University Hospital
Key exclusion criteria (1 listed)
- Visiting staffs of National Taiwan University Hospital
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 |
|---|---|---|
| Cause classification of OHCA protocoltraining program with cause classification of OHCA protocol | Behavioural | cause classification of OHCA protocol |
Primary outcome
diagnostic consistency between protocolized diagnosis and the discharge diagnosis
Time frame: 3 months
The diagnosis made by young physicians with protocol defined as protocolized diagnosis. Expert diagnosis was recognized as diagnosis identified by expert physician. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. The discharge diagnosis is the major diagnosis related to index cardiac arrest. The Light's kappa was used to evaluate the consistency of OHCA classification.
diagnostic consistency between protocolized diagnosis and the expert diagnosis
Time frame: 3 months
The diagnosis made by young physicians with protocol defined as protocolized diagnosis. Expert diagnosis was recognized as diagnosis identified by expert physician. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. The discharge diagnosis is the major diagnosis related to index cardiac arrest. The Light's kappa was used to evaluate the consistency of OHCA classification.
3 secondary outcomes
Portion of sufficient confidence to make proper OHCA cause identification
Time frame: 2 months
the accuracy rates on the classification test of OHCA cause before and after the lecture
Time frame: baseline, 2 weeks
diagnostic consistency between participants before and after the lecture
Time frame: baseline, 2 weeks
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 28 Aug 2023.
Related trials for Out-Of-Hospital Cardiac Arrest
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
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
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.
Min-Shan Tsai, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cause classification of OHCA protocol in people with Out-Of-Hospital Cardiac Arrest, run by National Taiwan University 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 1 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 28 Aug 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?
diagnostic consistency between protocolized diagnosis and the discharge diagnosis (time frame: 3 months). The study lists 2 primary outcomes in all. 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 28 Aug 2023.