Optimisation of defibrillation for ventricular fibrillation: the use of low tilt waveforms for the defibrillation of ventricular fibrillation
| ISRCTN | ISRCTN06531828 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06531828 |
| Protocol serial number | RGHT000386 |
| Sponsor | Royal Hospitals Trust (UK) |
| Funder | The Heart Trust Fund (UK) |
- Submission date
- 01/05/2007
- Registration date
- 30/07/2007
- Last edited
- 09/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jennifer Adgey
Scientific
Scientific
Regional Medical Cardiology Centre
Royal Hospitals
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, controlled, safety and feasability study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Overall survival rates from Ventricular Fibrillation (VF) are currently very poor. A more efficient biphasic defibrillator with novel low-tilt technology could improve the chances of terminating VF early thus increasing the chances of survival. The primary aim of this study is to determine whether the use of a defibrillator with a low-tilt biphasic waveform will improve the success of defibrillation of ventricular fibrillation. |
| Ethics approval(s) | This project has been reviewed and approved by the Office for Research Ethics Committees in Northern Ireland (ORECNI) on the 8th November 2006 (ref: 06/NIR02/108). |
| Health condition(s) or problem(s) studied | Ventricular fibrillation/cardiac arrest |
| Intervention | This will be a safety and feasibility study which aims to show equivalence in the removal of ventricular fibrillation during cardiac arrests between a novel low-tilt defibrillating device and the standard-tilted defibrillator currently in use in the trust (Philips Agilent Heartstart XL). Standard-tilted biphasic defibrillators are currently available on all hospital wards, to the cardiac arrest team and the physician-led cardiac ambulance. Randomisation will occur on a daily basis between the novel low-tilt device and the standard-tilted defibrillator. The randomised device will be made available to the cardiac arrest team, in the coronary care unit and also to the physician-led cardiac ambulance. It will not be possible to blind those staff delivering the defibrillating shocks to the device in use due to their appearances. Patients found to be in VF will receive treatment according to the resuscitation guidelines issued by the Resuscitation Council (UK) 2005. The standard-tilted device will deliver shocks at 150 J and the low-tilt device 120 J. Following any three unsuccessful shocks, a rescue shock of 200 J will be used from the standard-tilted defibrillator. All shocks will be delivered via standard self-adhesive pads which have previously been validated for clinical use. Defibrillating shocks will be delivered by a doctor, nurse or resuscitation officer who is fully trained in advanced life support. The following non-invasive parameters will also be recorded and analysed: 1. Time from collapse to arrival of emergency services 2. Time to first shock 3. Whether Cardio-Pulmonary Resuscitation (CPR) is performed pre-shock 4. Any delays in shock delivery 5. Duration of arrest 6. Drugs administered 7. Patient demographics 7. Aetiology of VF (where possible) There will be no follow up of any patients. Patients will only be included in the study at the time of required defibrillation. |
| Intervention type | Other |
| Primary outcome measure(s) |
The primary endpoint of the study will be termination of ventricular arrhythmia for greater than or equal to five seconds following shock delivery. This will be determined by analysis of the defibrillator Electrocardiogram (ECG) tracing post-cardiac arrest. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 110 |
| Key inclusion criteria | All adult patients in cardiac arrest with ventricular fibrillation as the identified rhythm. |
| Key exclusion criteria | Patients with existing 'Do not resuscitate' orders. |
| Date of first enrolment | 01/12/2006 |
| Date of final enrolment | 30/11/2007 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
Study participating centre
Regional Medical Cardiology Centre
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/11/2007 | Yes | No | ||
| Results article | results | 01/12/2012 | Yes | No |
