| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN06531828 |
| Date ISRCTN assigned | 30/07/2007 |
| Local reference number(s) | RGHT000386 |
| Public title | Optimisation of defibrillation for ventricular fibrillation: the use of low tilt waveforms for the defibrillation of ventricular fibrillation |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Ventricular fibrillation/cardiac arrest |
| Study hypothesis | 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. |
| Design/methodology | Randomised, controlled, safety and feasability study |
| Research ethics review | 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). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | All adult patients in cardiac arrest with ventricular fibrillation as the identified rhythm. |
| Participants - exclusion criteria | Patients with existing 'Do not resuscitate' orders. |
| Patient information material |
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| Anticipated start date | 01/12/2006 |
| Anticipated end date | 30/11/2007 |
| Status of trial | Completed |
| Target number of participants | 110 |
| Interventions | 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. |
| 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. |
| Secondary outcome measure(s) | No secondary outcome measures |
| Publications | Darragh KM, Doyle C, Walsh SJ, Allen JD, Adgey AAJ, Anderson J, Manoharan G. A novel low tilt biphasic waveform is more efficacious than a standard waveform in the defibrillation of VF. (Abstract) Journal of Electrocardiology, 2007. In Press |
| Sources of funding | The Heart Trust Fund (UK) |
| Sponsor name | Royal Hospitals Trust (UK) |
| Sponsor details | Royal Research Office
Grosvenor Road
Belfast
United Kingdom
BT12 6BA |
| Sponsor website | http://www.belfasttrust.hscni.net/ |
| Contact name | Prof Jennifer Adgey |
| Contact details | Regional Medical Cardiology Centre
Royal Hospitals
Grosvenor Road
Belfast
United Kingdom
BT12 6BA |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN06531828 |
| Date last extracted from ISRCTN register | 17/04/2008 |
