Cardiac ArrestIVFODNCT02952105
Identification of Ventricular Fibrillation and Optimization of Defibrillation During CPR
An observational study of Cardiac Arrest and Identify of Electrocadiac Rhythm, run by The First Affiliated Hospital of Henan University of Science and Technology at 1 site in China.
Trial summary
It's so important to recognize ventricular fibrillation in cardiac arrest and defibrillation early. At the same time Research findings have identified high-quality CPR with minimum interruption is critical to the success of defibrillation therapy. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Cardiac Arrest, Identify of Electrocadiac Rhythm
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to May 2018
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: cardiac arrest patients aged more than 14 years
Who may be able to join
- Cardiac arrest patients
- The length from cardia arrest to be rescued is less than 10 minutes
- age≥14
- Complied with ethical requirements
- signing the informed consent form.
Who cannot join
- DNR
- Pregnant women
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
About this study
Official title: Identification of Ventricular Fibrillation and Optimization of Defibrillation During Chest Compression of CPR: A Multiple Study of Cardiac Arrest Patients in China.
It's so important to recognize ventricular fibrillation in cardiac arrest and defibrillation early. At the same time Research findings have identified high-quality CPR with minimum interruption is critical to the success of defibrillation therapy. Both the guidelines by American Heart Association and the guidelines by European Resuscitation Council emphasize the importance of minimizing interruptions in chest compressions, specifically, duration of the pre-shock and post-shock pauses. So AHA indicate that there will be a new algorithm of VF during chest compression, which has high sensitivity and specificity. And the investigators can identify VF and defibrillate earlier.
The aim of this study is to verify that if Sherlock algorithm of Philips MRx monitor/defibrillator can identify shockable rhythms during chest compression accurately.
- Conditions
- Cardiac Arrest, Identify of Electrocadiac Rhythm
- Keywords
- cardiac arrest, identify of electrocardiac rhythm, ventricuar fibrillation, defibrillation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| defibrillation patients | shockable rhythm, defibrillated | |
| non defibrillation patients | non-shockable rhythm, non defibrillated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of Sherlock algorithm of Philips MRx monitor/defibrillator in identify ventricular fibrillation.
Measured: 04/10/2016-10/01/2017
How long it is advanced that the first time Sherlock algorithm identified VF than the true time VF was recognized.
Measured: 04/10/2016-10/01/2017
Comparasion of no-flue time between true scene and assumed scene that useing Sherlock algorithm.
Measured: 04/10/2016-10/01/2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Jinhua Central Hospital
- Responsible party
- Sponsor
- Investigators
- Xuezhong Yu, Doctor, Study chair, Peking Union Medical College HospitalGuoxiu Zhang, Bachelor, Study director, The First Affiliated Hospital of Henan University of Science and TechnologyMingwei Huang, Bachelor, Study director, Jinhua Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952105
- Sponsor's protocol ID
- UST20161009
- Acronym
- IVFOD
- Status last verified
- Oct 2016
- First submitted
- 30 Oct 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Ventricular Fibrillation and Optimization of Defibrillation During Chest Compression of CPR: A Multiple Study of Cardiac Arrest Patients in China.
- ClinicalTrials.gov ID
- NCT02952105
- Acronym / sponsor ID
- IVFOD / UST20161009
- Conditions
- Cardiac Arrest, Identify of Electrocadiac Rhythm
- Keywords
- cardiac arrest, identify of electrocardiac rhythm, ventricuar fibrillation, defibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Jinhua Central Hospital
- Study start
- Apr 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 2 Nov 2016 (estimated)
- 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.
It's so important to recognize ventricular fibrillation in cardiac arrest and defibrillation early. At the same time Research findings have identified high-quality CPR with minimum interruption is critical to the success of defibrillation therapy. Both the guidelines by American Heart Association and the guidelines by European Resuscitation Council emphasize the importance of minimizing interruptions in chest compressions, specifically, duration of the pre-shock and post-shock pauses. So AHA indicate that there will be a new algorithm of VF during chest compression, which has high sensitivity and specificity. And the investigators can identify VF and defibrillate earlier.
The aim of this study is to verify that if Sherlock algorithm of Philips MRx monitor/defibrillator can identify shockable rhythms during chest compression accurately.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| defibrillation patients | – | –shockable rhythm, defibrillated |
| non defibrillation patients | – | –non-shockable rhythm, non defibrillated |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cardiac arrest patients aged more than 14 years
Key inclusion criteria (5 listed)
- Cardiac arrest patients
- The length from cardia arrest to be rescued is less than 10 minutes
- age≥14
- Complied with ethical requirements
- signing the informed consent form.
Key exclusion criteria (2 listed)
- DNR
- Pregnant women
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
Sensitivity and specificity of Sherlock algorithm of Philips MRx monitor/defibrillator in identify ventricular fibrillation.
Time frame: 04/10/2016-10/01/2017
How long it is advanced that the first time Sherlock algorithm identified VF than the true time VF was recognized.
Time frame: 04/10/2016-10/01/2017
Comparasion of no-flue time between true scene and assumed scene that useing Sherlock algorithm.
Time frame: 04/10/2016-10/01/2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
Xuezhong Yu, Doctor study chair
Peking Union Medical College Hospital
Guoxiu Zhang, Bachelor study director
The First Affiliated Hospital of Henan University of Science and Technology
Mingwei Huang, Bachelor study director
Jinhua Central 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 Cardiac Arrest and Identify of Electrocadiac Rhythm, run by The First Affiliated Hospital of Henan University of Science and Technology at 1 site in China.
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 5 inclusion and 2 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 2 Nov 2016. 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 China. 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?
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?
Sensitivity and specificity of Sherlock algorithm of Philips MRx monitor/defibrillator in identify ventricular fibrillation. (time frame: 04/10/2016-10/01/2017). The study lists 3 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 2 Nov 2016.