Cardiac EventNCT01665755
To Determine Optimal Time for Delivering Electrical Shocks to Cardiac Arrest Patients
A study testing Upstroke Compression Defibrillation and Precompression Defibrillation in people with Cardiac Event and Sudden Cardiac Death, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
In this study, we are comparing the difference in outcomes between patients who were given shocks to the heart, during the upstroke of cardiopulmonary resuscitation (CPR) and before CPR is started. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cardiac Event, Sudden Cardiac Death, Death
- What is being tested?
- Upstroke Compression Defibrillation and Precompression Defibrillation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2016to 3 Apr 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiac Arrest patients who received eith CPR and/or defibrillation
- Ventricular Fibrillation or Pulseless Ventricular Tachycardia
Who cannot join
- Patients pronounced dead without attempting CPR according to standard operating procedure and ILCOR guidelines
- Cardiac arrest obviously caused by major trauma
- Children below age 21
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Randomised Controlled Trial Comparing Shock Success With Synchronized Defibrillation (Compression Upstroke Versus Precompression) During Ongoing Mechanical Cardiopulmonary Resuscitation In The Emergency Department
In this study, we are comparing the difference in outcomes between patients who were given shocks to the heart, during the upstroke of cardiopulmonary resuscitation (CPR) and before CPR is started. The study population will be all cardiac arrest patients attended by the staff of the Emergency Department who fulfil the eligibility criteria. Patients will be managed according to currently approved cardiac arrest protocols. Patients confirmed in cardiac arrest have manual chest compressions started while mechanical CPR (whereby chest compressions are delivered by an automated device) is prepared. Mechanical CPR should be started as soon as possible (<1 minute). If patients are eligible to be shocked, they will receive shocks either during upstroke of CPR or before CPR is started.
Thus the purpose of this study is to answer the question whether are there improvement in survival between when shocks are given during upstroke and before CPR is started.
Read the detailed description
The purpose of this study will be to compare shock success during defibrillation synchronized with the upstroke of chest compression (peak upstroke), and precompression (control). This will be the world's first study to characterize the phase dependency of defibrillation during mechanical CPR in humans and to evaluate if optimal synchronized defibrillation can improve clinical outcomes.
The null hypothesis would be that there is no difference in shock success during defibrillation synchronized with the upstroke of chest compression (peak upstroke), and precompression (control). We will conduct statistical comparisons for the primary and secondary outcomes between the arms of the study.
The study population will be all cardiac arrest patients attended by the staff of the ED over the study period who fulfill the eligibility criteria. Patients will be managed according to currently approved cardiac arrest protocols. Patients confirmed in cardiac arrest with have manual chest compressions started while mechanical CPR is prepared. Mechanical CPR should be started as soon as possible (<1 minunte). If a shockable rhythm is present (VF/VT), patients will receive one of pre-randomized defibrillation protocols:
- Synchronised defibrillation at peak-upstroke
- Synchronised defibrillation at precompression
Definition of outcomes
- Shock success is defined as the termination of Ventricular Fibrillation (VF) or pulseless Ventricular Tachycardia (VT) and the establishment of organized rhythm within 60 seconds. An organized rhythm requires at least 2 QRS complexes separated by no more than 5 seconds.
- Survival to hospital discharge is defined as patient surviving the primary event and discharged from the hospital alive.
- Return of spontaneous circulation is defined as the presence of any palpable pulse, which is detected by manual palpation of a major artery.
- Survival to admission is defined as the admission to hospital without ongoing CPR or other artificial circulatory support.
- Conditions
- Cardiac Event, Sudden Cardiac Death, Death, Ventricular Fibrillation, Ventricular Tachycardia
- Being tested
- Upstroke Compression Defibrillation, Precompression Defibrillation
- Medical subject headings
- Cardiovascular Diseases, Death, Sudden, Cardiac, Death, Ventricular Fibrillation, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upstroke Compression DefibrillationDevice
Precompression DefibrillationDevice
| Study group | Role | What they receive |
|---|---|---|
| Precompression | Experimental | Control arm Receives: Device: Precompression Defibrillation |
| Upstroke Compression | Active comparator | Intervention arm Receives: Device: Upstroke Compression Defibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful electrical conversion (shock success)
Termination of Ventricular Fibrillation (VF) or pulseless Ventricular Tachycardia (VT) and the establishment of organized rhythm within 60 seconds. An organized rhythm requires at least 2 QRS complexes separated by no more than 5 seconds.
Measured: establishment of organized rhythm within 60 seconds
Secondary outcomes (6)
termination of VF regardless of the resulting rhythm
Measured: at least 5 seconds after the shock
Return of spontaneous circulation (ROSC)
Measured: at least 20 minutes
Survival to hospital admission
Measured: at least 1 day
Survival to hospital discharge
Measured: at least 1 day
Functional survival outcomes assessed by the Glasgow Outcomes Score (CPC/OPC)
Measured: at least 1 day
European Quality of Life in 5 Dimensions
Measured: at least 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startJan 2016
- Primary completionMar 2018
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac EventStudies of the same condition, open and under way.
- More trials run by Singapore General 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zoll Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Marcus Eng Hock Ong, MBBS, FRCS, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665755
- Sponsor's protocol ID
- 2011/456/C
- Status last verified
- Sep 2019
- First submitted
- 6 Aug 2012
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomised Controlled Trial Comparing Shock Success With Synchronized Defibrillation (Compression Upstroke Versus Precompression) During Ongoing Mechanical Cardiopulmonary Resuscitation In The Emergency Department
- ClinicalTrials.gov ID
- NCT01665755
- Acronym / sponsor ID
- 2011/456/C
- Conditions
- Cardiac Event, Sudden Cardiac Death, Death, Ventricular Fibrillation, Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Zoll Medical Corporation
- Study start
- Jan 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 15 Aug 2012 (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.
In this study, we are comparing the difference in outcomes between patients who were given shocks to the heart, during the upstroke of cardiopulmonary resuscitation (CPR) and before CPR is started. The study population will be all cardiac arrest patients attended by the staff of the Emergency Department who fulfil the eligibility criteria. Patients will be managed according to currently approved cardiac arrest protocols. Patients confirmed in cardiac arrest have manual chest compressions started while mechanical CPR (whereby chest compressions are delivered by an automated device) is prepared. Mechanical CPR should be started as soon as possible (<1 minute). If patients are eligible to be shocked, they will receive shocks either during upstroke of CPR or before CPR is started.
Thus the purpose of this study is to answer the question whether are there improvement in survival between when shocks are given during upstroke and before CPR is started.
Detailed description
The purpose of this study will be to compare shock success during defibrillation synchronized with the upstroke of chest compression (peak upstroke), and precompression (control). This will be the world's first study to characterize the phase dependency of defibrillation during mechanical CPR in humans and to evaluate if optimal synchronized defibrillation can improve clinical outcomes.
The null hypothesis would be that there is no difference in shock success during defibrillation synchronized with the upstroke of chest compression (peak upstroke), and precompression (control). We will conduct statistical comparisons for the primary and secondary outcomes between the arms of the study.
The study population will be all cardiac arrest patients attended by the staff of the ED over the study period who fulfill the eligibility criteria. Patients will be managed according to currently approved cardiac arrest protocols. Patients confirmed in cardiac arrest with have manual chest compressions started while mechanical CPR is prepared. Mechanical CPR should be started as soon as possible (<1 minunte). If a shockable rhythm is present (VF/VT), patients will receive one of pre-randomized defibrillation protocols:
- Synchronised defibrillation at peak-upstroke
- Synchronised defibrillation at precompression
Definition of outcomes
- Shock success is defined as the termination of Ventricular Fibrillation (VF) or pulseless Ventricular Tachycardia (VT) and the establishment of organized rhythm within 60 seconds. An organized rhythm requires at least 2 QRS complexes separated by no more than 5 seconds.
- Survival to hospital discharge is defined as patient surviving the primary event and discharged from the hospital alive.
- Return of spontaneous circulation is defined as the presence of any palpable pulse, which is detected by manual palpation of a major artery.
- Survival to admission is defined as the admission to hospital without ongoing CPR or other artificial circulatory support.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precompression | Experimental | Device: Precompression DefibrillationControl arm |
| Upstroke Compression | Active comparator | Device: Upstroke Compression DefibrillationIntervention arm |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cardiac Arrest patients who received eith CPR and/or defibrillation
- Ventricular Fibrillation or Pulseless Ventricular Tachycardia
Key exclusion criteria (4 listed)
- Patients pronounced dead without attempting CPR according to standard operating procedure and ILCOR guidelines
- Cardiac arrest obviously caused by major trauma
- Children below age 21
- Patients who are pregnant
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 |
|---|---|---|
| Upstroke Compression Defibrillation | Device | Upstroke Compression |
| Precompression Defibrillation | Device | Precompression |
Primary outcome
successful electrical conversion (shock success)
Time frame: establishment of organized rhythm within 60 seconds
Termination of Ventricular Fibrillation (VF) or pulseless Ventricular Tachycardia (VT) and the establishment of organized rhythm within 60 seconds. An organized rhythm requires at least 2 QRS complexes separated by no more than 5 seconds.
6 secondary outcomes
termination of VF regardless of the resulting rhythm
Time frame: at least 5 seconds after the shock
Return of spontaneous circulation (ROSC)
Time frame: at least 20 minutes
Survival to hospital admission
Time frame: at least 1 day
Survival to hospital discharge
Time frame: at least 1 day
Functional survival outcomes assessed by the Glasgow Outcomes Score (CPC/OPC)
Time frame: at least 1 day
European Quality of Life in 5 Dimensions
Time frame: at least 1 day
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 20 Sep 2019.
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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.
Marcus Eng Hock Ong, MBBS, FRCS principal investigator
Singapore General 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 Upstroke Compression Defibrillation and Precompression Defibrillation in people with Cardiac Event and Sudden Cardiac Death, run by Singapore General Hospital at 1 site in Singapore.
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 2 inclusion and 4 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 20 Sep 2019. 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 Singapore. 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?
successful electrical conversion (shock success) (time frame: establishment of organized rhythm within 60 seconds). 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 20 Sep 2019.