What is the purpose of the study?
At the moment, we do not know the best way for NHS paramedics to manage the patient’s airway during an out of hospital cardiac arrest (OHCA). Historically tracheal intubation has been considered the best method. However, tracheal intubation can cause significant complications as well as interruptions in chest compressions.
National recommendations suggest that a newer device, the supraglottic airway device (SAD), may be better than tracheal intubation. SADs are already used during routine anaesthesia in hospital; in emergency care, they are quicker to insert and cause less interruption to chest compressions. However, a SAD may not stay in place as securely as a tracheal tube and, if a patient vomits, stomach contents may get into their lungs.
There is real uncertainty amongst paramedics and experts in the field about the best method to ensure a clear airway during the early stages of OHCA. We are therefore undertaking a large research study to determine whether intubation or the best available SAD (the i-gel) gives the best chance of recovery following OHCA.
Why have I been invited?
All paramedics working in operational duties for: East of England Ambulance Service NHS Trust; East Midlands Ambulance Service NHS Trust; South Western Ambulance Service NHS Foundation Trust and Yorkshire Ambulance Service NHS Trust are being invited to take part. We are aiming to recruit 1,300 paramedics in total. Paramedics working in non-clinical and managerial roles who do not routinely attend OHCA will be unable to take part.
What will happen to me if I take part?
If you return the expression of interest form the research team will contact you to invite you to attend a trial specific training. This session is structured and will last approximately 2 hours.
Initial training – Part 1
The first part of the training session will include a presentation that reviews current resuscitation guidelines and the options available for airway management. It will consist of training on study procedures, data collection and we will explain the purpose of the trial, equipoise and the need to follow trial protocols.
At this stage you will be given the opportunity to ask questions and then we will invite you to complete a consent form. If you no longer wish to participate in the study you will be free to leave the training session.
Once you have consented to take part in the study you will be randomly allocated to one of the two study arms and asked to use either the i-gel supraglottic airway device or tracheal intubation as your initial approach to airway management at every adult non-traumatic cardiac arrest that you attend over the following 24 months. In both study arms a short period of bag-mask ventilation may be used prior to your allocated device.
Note that the trial only specifies your initial airway management technique; if this proves unsuccessful subsequent airway management will follow recognised algorithms, applied using your clinical judgement in the patient’s best interests. Once the research has finished you will return to your usual practice, and additional training will be provided at the end of the study so you do not de-skill as a result of taking part.
Initial training– Part 2
The second part of your initial training session will be tailored to the trial group to which you are randomised. You will complete technical training on either the i-gel or tracheal intubation.
The training will be provided in accordance with manufacturer’s guidelines and you will be allowed as much time as you need to repeatedly practice on the manikin until you are confident with the technique. You will then complete a brief verbal and practical assessment.
The training session will close with a reminder of the study’s purpose and protocol, familiarisation with the data collection form and an opportunity to ask questions and review.
If you are randomised to the i-gel arm, you will be issued with a personal supply of the device, and will be required to account for each use. Additional supplies of the i-gel will be issued by the Research Paramedic in exchange for completed data collection form.
What will I have to do?
You will not be able to recruit patients until you have attended the training described above, but once you have completed training (and from the start date of the study 01/06/2015) you will be required to use your allocated method of airway management for every adult non-traumatic cardiac arrest that you attend during the 24 month study period unless you are the third or later paramedic to arrive, or another paramedic participating in the trial arrives at scene before you, in which case they will manage the airway according to their study allocation, and you will assist as you would normally.
Each time you attend a cardiac arrest you will be required to complete a Case Record Form (CRF) and return it to the study Research Paramedic in your trust (contact details below). This will take no more than a few minutes.
You will be invited to attend refresher training after 12 months and exit training at the end of the study, which will concentrate on refreshing your skills in the airway management technique that you were not allocated to use during the trial.
Expenses and payments
The following payments will be made to you if you decide to take part in the study in recognition of your time spent training:
– You will be entitled to receive overtime payments for the time you spend at study training sessions
– You will be able to claim reasonable travel expenses for attending the training.
What alternatives are there to taking part in the study?
If you choose not to take part you will continue to manage cardiac arrests in the usual way, and there will be no penalty or disadvantage to you.
What are the possible benefits of taking part?
If you decide to take part you will receive additional training, and a chance to participate in this research study. Ultimately, future cardiac arrest patients may benefit from improved airway management partly as a result of the information that you collect during this research study.
This is the first major research study to be undertaken in this area, and provides an exciting opportunity for paramedics to engage in pre-hospital research, receive expert led education in airway management, undertake CPD that relates directly to your clinical practice and inform future paramedic practice. If you are interested in taking part or would like further information, please contact our lead research paramedic, Kim Kirby at Kim.Kirby@swast.nhs.uk.
Will my taking part in the study be kept confidential?
All study data will be anonymised so you cannot be identified as an individual in any report, presentation, research paper or other study output. Your clinical skills will not be compared to other paramedics. The findings from the study will be reported in medical journals or presented at meetings but your identity will not be disclosed. During the course of the study we will ask you if you would like to receive a summary of the results by post after the research has finished.