CardiologyNCT04967261
The Evaluation of Optimal Observation Period for Neurological Recovery in Post-arrest Survivors
An observational study of Cardiology, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To explore whether the patient's neurological function recovery period is sufficient after successful emergency resuscitation recommended by the current guidelines Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiology
- How many people
- 529 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2021to 16 Mar 2022
- 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 with non-traumatic cardiac arrest who have been successfully resuscitated by first aid and admitted to the intensive care unit
Who may be able to join
- Patients with non-traumatic cardiac arrest in the emergency room of National Taiwan University Hospital (including pre-hospital cardiac arrest and in-hospital cardiac arrest) after successful emergency resuscitation
Who cannot join
- Under 20 years old
- Pregnant women
- Those who have not been admitted to the intensive care unit
- Unconsciousness before the heartbeat stops
- A clear consciousness after successful first aid resuscitation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, Zhongshan South Road, No. 7
About this study
To explore whether the patient's neurological function recovery period is sufficient after successful emergency resuscitation recommended by the current guidelines
Read the detailed description
The research team will collect patient data after successful emergency resuscitation after cardiac arrest in the emergency room of National Taiwan University Hospital, and will collect and analyze the relationship between the time for patients to regain consciousness and drug use, hemodynamic changes, and neurological examination results after resuscitation. To explore whether the patient population needs to extend the observation time of neurological function after a certain CPR emergency treatment, and allow the patient to have a longer observation period to regain consciousness.
- Conditions
- Cardiology
- Keywords
- Cardiac arrest, post-cardiac arrest syndrome, neurological outcome
- Medical subject headings
- Heart Arrest, Post-Cardiac Arrest Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
In-hospital mortality
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 posted19 Jul 2021
- Study start1 Aug 2021
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiologyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 529 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
- NCT04967261
- Sponsor's protocol ID
- 202106019RINB
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Optimal Observation Period for Neurological Recovery in Post-arrest Survivors
- ClinicalTrials.gov ID
- NCT04967261
- Acronym / sponsor ID
- 202106019RINB
- Conditions
- Cardiology
- Keywords
- Cardiac arrest, post-cardiac arrest syndrome, neurological outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 529 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 19 Jul 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.
To explore whether the patient's neurological function recovery period is sufficient after successful emergency resuscitation recommended by the current guidelines
Detailed description
The research team will collect patient data after successful emergency resuscitation after cardiac arrest in the emergency room of National Taiwan University Hospital, and will collect and analyze the relationship between the time for patients to regain consciousness and drug use, hemodynamic changes, and neurological examination results after resuscitation. To explore whether the patient population needs to extend the observation time of neurological function after a certain CPR emergency treatment, and allow the patient to have a longer observation period to regain consciousness.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-traumatic cardiac arrest who have been successfully resuscitated by first aid and admitted to the intensive care unit
Key inclusion criteria (1 listed)
- Patients with non-traumatic cardiac arrest in the emergency room of National Taiwan University Hospital (including pre-hospital cardiac arrest and in-hospital cardiac arrest) after successful emergency resuscitation
Key exclusion criteria (5 listed)
- Under 20 years old
- Pregnant women
- Those who have not been admitted to the intensive care unit
- Unconsciousness before the heartbeat stops
- A clear consciousness after successful first aid resuscitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: through study completion, an average of 1 year
In-hospital mortality
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 19 Sep 2022.
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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.
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?
An observational study of Cardiology, 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 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: finished, as of the sponsor's last update on 19 Sep 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 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?
Mortality (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?
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 19 Sep 2022.