VectOr ChAnge defibriLlatIon in Refractory Shockable rhyThms
NCT ID: NCT05926973
Last Updated: 2023-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
50 participants
OBSERVATIONAL
2023-05-01
2023-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Delivering shocks with the LUCAS mechanical CPR device running
* After 5 shocks have been delivered placing new pads in the Anterior Posterior (AP) position
* Delivering shocks using the TVAA Tempus Pro defibrillator rather than the Ambulance Service defibrillator.
This bundle was based on recommendations from ILCOR and the Resus Council (UK) Advanced Life Support manual and was launched in October 2021.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Refractory Out-Of-Hospital Cardiac Arrest Treated With Mechanical CPR, Hypothermia, ECMO and Early Reperfusion
NCT01186614
Cardiopulmonary Resuscitation Performance of Professional Rescuers With a New Defibrillation Algorithm
NCT04691089
AED Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute"
NCT00139542
Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm
NCT06835491
Selection of Shock Energy in Out-Of-Hospital Cardiac Arrest
NCT00472147
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study design
PICOST Population - adult patients with medical cardiac arrest in refractory shockable rhythms (defined as continuous VF or VT after 5 shocks).
Intervention - application of the TVAA enhanced cardiac arrest bundle Comparison - 18 month period before the introduction of the bundle (if the COVID period has significantly different response times than the intervention group then the COVID period will be excluded).
Outcome - primary outcome measure is ROSC at hospital (as this represents the success of the pre-hospital phase of resuscitation).
Study design - Retrospective observational study using the TVAA HEMSBASE database Timeframe - 18 months of data since the bundle was introduced.
Exclusions - traumatic cardiac arrests, cardiac arrests where the VF/VT was recurrent (could be terminated but then restarted) rather than refractory (unable to get the patient out of the shockable rhythm). Refractory VF refers to VF that persists despite shock delivery (i.e. shock-resistant VF). This is distinguished from recurrent VF, which is VF that re-appears after it has been terminated (2). In this study refractory would be defined as continuous VF or VT after 5 shocks.
Data set to be collected All data is held within HEMSBASE Age, sex, witnessed arrest, bystander CPR, time from 999 call to TVAA on scene, first rhythm, number of shocks (total in before group; number of shocks pre and post vector change in the after group), outcome (ROSC at any stage; PLE, died on arrival to ED, ROSC in ED).
Statistical analysis Statistical support will be sought from the South Central Research Design Service https://www.rds-sc.nihr.ac.uk Fisher's test or Chi square tests may be appropriate.
Ethical approval The HRA decision tools indicate that the study does not require REC review.
Search strategy Two independent researchers will search HEMSBASE for the intervention period (Oct 21 to April 23) and the control period (19 months prior to Oct 21, excluding the COVID period if response times are significantly different in this period) using the following strategy.
HEMSBASE search
* Cardiac arrests
* Initial rhythm VF or VT
* Manual search looking for refractory shockable rhythms (defined as continuous VF or VT after 5 shocks with no change to ROSC or a non shockable rhythm at any stage).
This search strategy will deliver a list of cases of refractory shockable rhythms that can then be compared between the two reviewers to ensure all cases are included, any cases where there is not agreement will be adjudicated by a third reviewer. The cases will then be analysed for the data set above and entered into an excel spreadsheet.
Data security No patient identifiable data will be exported outside of HEMSBASE.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Before intervention
Standard care as per ALS guidelines prior to October 2021
No interventions assigned to this group
After intervention
Enhanced cardiac arrest management as per TVAA guideline from October 2021 onwards
Enhanced cardiac arrest bundle
* Delivering shocks with the LUCAS mechanical CPR device running
* After 5 shocks have been delivered placing new pads in the Anterior Posterior (AP) position
* Delivering shocks using the TVAA Tempus Pro defibrillator rather than the Ambulance Service defibrillator.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Enhanced cardiac arrest bundle
* Delivering shocks with the LUCAS mechanical CPR device running
* After 5 shocks have been delivered placing new pads in the Anterior Posterior (AP) position
* Delivering shocks using the TVAA Tempus Pro defibrillator rather than the Ambulance Service defibrillator.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* in refractory shockable rhythms (defined as continuous VF or VT after 5 shocks).
Exclusion Criteria
* cardiac arrests where the VF/VT was recurrent (could be terminated but then restarted) rather than refractory (unable to get the patient out of the shockable rhythm). Refractory VF refers to VF that persists despite shock delivery (i.e. shock-resistant VF). This is distinguished from recurrent VF, which is VF that re-appears after it has been terminated (2). In this study refractory would be defined as continuous VF or VT after 5 shocks.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Thames Valley Air Ambulance
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
James Raitt
Audit, Improvement and Research Lead
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Thames Valley Air Ambulance
Oxford, Oxfordshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TVAA02/23
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.