Condition category
Injury, Occupational Diseases, Poisoning
Date applied
24/05/2012
Date assigned
24/05/2012
Last edited
21/01/2016
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

Dr Sarah Voss

ORCID ID

Contact details

Faculty of Health & Life Sciences
Glenside Campus
Blackberry Hill
Bristol
BS16 1DD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11962

Study information

Scientific title

Randomised comparison of the effectiveness of the Laryngeal Mask Airway Supreme, i-gel and current practice in the initial airway management of pre-hospital cardiac arrest: a feasibility study (REVIVE-Airways)

Acronym

REVIVE

Study hypothesis

Cardiac arrest occurs when the heart suddenly stops beating, and is one of the most extreme medical emergencies. Outcomes remain poor with most patients not surviving. Effective treatments for cardiac arrest are limited and represent a major unmet health need. The main treatment is cardiopulmonary resuscitation (CPR), which is a combination of rescue breathing and chest compressions. Prompt and effective CPR is essential to prevent damage to the brain and other organs. Minimising interruptions of continuous chest compressions improves survival.

Current evidence supports a change in rescue breathing. Historically, placing a breathing tube in the windpipe (tracheal intubation) was viewed as the best pre-hospital airway management in cardiac arrest, but we now know that attempting intubation can lead to significant complications and prolonged interruptions in chest compressions. As a result, national recommendations advocate using newer airway devices (supraglottic airway devices: SADs). These are quicker to insert and cause minimal interruption to chest compressions. However the best type of SAD and their effectiveness in comparison to current practice is unknown.

This research study is a preliminary investigation to determine whether our proposed design will allow us to compare the two most promising SADs (i-gel and LMAS) with current practice during pre-hospital cardiac arrest. This will be done by dividing paramedics working in Great Western Ambulance Service, and who agree to take part, into three groups. Each group will be given structured education on CPR and rescue breathing. One group will be taught to use the i-gel, one group the LMAS and one group will continue as usual. If this research design works, and produces useful results, we will proceed to a large scale study to determine whether one of these approaches improves patient survival. This will shape future guidelines and benefit cardiac arrest patients in the UK and internationally.

More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11962

Ethics approval

First MREC 31/10/2011 ref: 11/EE/0407

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Injuries and Emergencies

Intervention

i-gel Arm, Patients attended by a paramedic who has been randomised to this arm will receive resuscitation according to the Resuscitation Council (UK) and JRCALC Advanced Life Support Guidelines, with the exception that the i-gel supra-glottic airway device will be used initially to manage the airway. All standard advanced life support interventions will be provided including drug administration, defibrillation and chest compressions as required.; LMAS Arm, Patients attended by a paramedic who has been randomised to this arm will receive resuscitation according to the Resuscitation Council (UK) and JRCALC Advanced Life Support Guidelines, with the exception that the Laryngeal Mask Airway Supreme (LMAS) supra-glottic airway device will be used initially to manage the airway. All standard advanced life support interventions will be provided including drug administration, defibrillation and chest compressions as required.

Usual Practice Arm, Patients attended by a paramedic who has been randomised to this arm will receive resuscitation according to the Resuscitation Council (UK) and JRCALC Advanced Life Support Guidelines. All standard advanced life support interventions will be provided including drug administration, defibrillation and chest compressions as required.; Follow Up Length: 3 month(s)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Assess if it is possible to conduct a full-scale study

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/03/2012

Overall trial end date

28/02/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Paramedics:
Working in Great Western Ambulance Service and consenting to participate

Patients:
1. Have had a cardiac arrest in the pre-hospital setting
2. Attempted resuscitation is appropriate according to standard guidelines
3. Aged 18 years or older
4. Target Gender: Male & Female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 534; UK Sample Size: 534; Description: The sample size of 534 comprises 150 paramedics and 384 patients

Participant exclusion criteria

Patients:
1. Less than 18 years old
2. Estimated weight is less than 50 kg
3. Mouth opening is less than 2 cm
4. The latter two exclusions have been applied because the SGAs evaluated in this trial are not designed for use in patients with low body weight or significantly reduced mouth opening.

Recruitment start date

01/03/2012

Recruitment end date

28/02/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Faculty of Health & Life Sciences
Bristol
BS16 1DD
United Kingdom

Sponsor information

Organisation

University Hospitals Bristol NHS Foundation Trust (UK)

Sponsor details

Research & Development
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
+44 117 923 0000
research@uhbristol.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.uhbristol.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23408081
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26787796

Publication citations

  1. Protocol

    Benger JR, Voss S, Coates D, Greenwood R, Nolan J, Rawstorne S, Rhys M, Thomas M, Randomised comparison of the effectiveness of the laryngeal mask airway supreme, i-gel and current practice in the initial airway management of prehospital cardiac arrest (REVIVE-Airways): a feasibility study research protocol., BMJ Open, 2013, 3, 2, doi: 10.1136/bmjopen-2012-002467.

  2. Results

    Benger J, Coates D, Davies S, Greenwood R, Nolan J, Rhys M, Thomas M, Voss S, Randomised comparison of the effectiveness of the laryngeal mask airway supreme, i-gel and current practice in the initial airway management of out of hospital cardiac arrest: a feasibility study, Br J Anaesth, 2016 , 116, 2, 262-268, doi: 10.1093/bja/aev477.

Additional files

Editorial Notes

21/01/2016: Publication reference added.