Condition category
Circulatory System
Date applied
01/05/2007
Date assigned
30/07/2007
Last edited
09/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jennifer Adgey

ORCID ID

Contact details

Regional Medical Cardiology Centre
Royal Hospitals
Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RGHT000386

Study information

Scientific title

Acronym

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.

Ethics approval

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).

Study design

Randomised, controlled, safety and feasability study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

No secondary outcome measures

Overall trial start date

01/12/2006

Overall trial end date

30/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

All adult patients in cardiac arrest with ventricular fibrillation as the identified rhythm.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

110

Participant exclusion criteria

Patients with existing 'Do not resuscitate' orders.

Recruitment start date

01/12/2006

Recruitment end date

30/11/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Regional Medical Cardiology Centre
Belfast
BT12 6BA
United Kingdom

Sponsor information

Organisation

Royal Hospitals Trust (UK)

Sponsor details

Royal Research Office
Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.belfasttrust.hscni.net/

Funders

Funder type

Charity

Funder name

The Heart Trust Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 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
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22579679

Publication citations

  1. Results

    Darragh KM, Manoharan G, Di Maio R, Stevenson M, Bennett JR, Walsh SJ, Allen JD, Anderson JM, Adgey AA, A low tilt waveform in the transthoracic defibrillation of ventricular arrhythmias during cardiac arrest., Resuscitation, 2012, 83, 12, 1438-1443, doi: 10.1016/j.resuscitation.2012.04.018.

Additional files

Editorial Notes