Airway Management Feasibility Study (REVIVE-Airways)

ISRCTN	ISRCTN18528625
DOI	https://doi.org/10.1186/ISRCTN18528625
Secondary identifying numbers	11962

Submission date: 24/05/2012
Registration date: 24/05/2012
Last edited: 21/01/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sarah Voss
Scientific

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

Study information

Study design	Randomised interventional trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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)
Study acronym	REVIVE
Study objectives	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(s)	First MREC 31/10/2011 ref: 11/EE/0407
Health condition(s) or problem(s) studied	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
Primary outcome measure	Assess if it is possible to conduct a full-scale study
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/03/2012
Completion date	28/02/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	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
Key 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
Key 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.
Date of first enrolment	01/03/2012
Date of final enrolment	28/02/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Faculty of Health & Life Sciences

Bristol
BS16 1DD
United Kingdom

Sponsor information

University Hospitals Bristol NHS Foundation Trust (UK)
Hospital/treatment centre

Research & Development
Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom

Phone	+44 117 923 0000
Email	research@uhbristol.nhs.uk
Website	http://www.uhbristol.nhs.uk/
"ROR"	https://ror.org/04nm1cv11

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	13/02/2013		Yes	No
Results article	results	01/02/2016		Yes	No

Editorial Notes

21/01/2016: Publication reference added.