Frequently Asked Questions for patients, relatives and the public

Why has this trial come about?

The two treatments that are being compared in the AIRWAYS-2 study (intubation or the best available supraglottic airway device (SGA), called the i-gel) are already in routine use in England, and people who have a cardiac arrest at the moment may get either treatment, depending on the guidelines issued by the local ambulance service and the preference of the attending ambulance staff.

However 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 out of hospital cardiac arrest (OHCA), and we are therefore doing this study to test out which approach leads to the best survival and recovery of these patients.

The results from this study (AIRWAYS-2) will shape OHCA guidelines and will yield real benefits to future patients in the UK and throughout the world.

Is experimenting like this on humans allowed? Is it legal to do this?

The legal basis for entering a patient into a trial in an emergency situation, before informed consent can be obtained, is set out in the Mental Capacity Act 2005 (section 32.9).

A member of the research team will seek consent for a patient to continue in the study as soon as they have recovered sufficiently and are able to give this consent. If a patient does not recover quickly we will seek the opinion of a close family member instead.

The way that patients are approached after the study, and the timing of this, has been discussed and agreed by our patient and public advisory group, which includes several people who have survived a cardiac arrest.

Particular care has been taken to ensure this project meets all legal and regulatory requirements.

The trial protocol and supporting documents have been reviewed and approved by the funding body, the National Institute for Health Research (NIHR); by an independent Research Ethics Committee (REC) who consider the need for the research and weigh up the risk and benefit for patients; and the Confidentiality Advisory Group (CAG), who review applications for research where consent from the patient cannot be obtained.

Is this trial ethical?

The AIRWAYS-2 trial has been reviewed and approved by the South-Central Oxford C Research Ethics Committee.

All research studies run in the NHS are conducted in accordance with the Research Governance Framework and relevant legislation.  The Health Research Authority provides ethical review of proposed research through NHS Research Ethics Committees (RECs) who scrutinise applications and put the rights, safety, dignity and well-being of research participants at the centre of their decision making.

NHS Research Ethics Committees consist of up to 18 members, a third of whom are lay (this means their main professional interest is not in a research area, nor are they a registered healthcare professional). They safeguard the rights, safety, dignity and well-being of research participants, independently of research sponsors.  They review applications for research and give an opinion about the proposed participant involvement and whether the research is ethical.

We acknowledge the expertise of the paramedics who are treating the patient and therefore any study paramedic can over-ride the trial procedures if they have a strong reason to believe that this is in the best interests of the patient.

Why can’t you compare data on patients who currently have one or the other treatment?

The only way to measure the true effectiveness of the i-gel SGA compared to tracheal intubation is to create two groups where patients in one group are randomised to receive the i-gel SGA and patients in the other group are randomised to receive tracheal intubation, allowing the two approaches to airway management to be compared in the same type of patient with similar characteristics (age, sex, medical history etc.). If we were to simply compare current data from everyday records, some patients may have been treated with an i-gel SGA because they got a pulse back quickly (for example after early delivery of an electrical shock (defibrillation)), so the data would show more survival in the group who had this treatment: this would not be a fair comparison of the two alternatives, and might give misleading results.

Why will people be entered into this trial without a relative’s permission or knowledge?

When a person becomes suddenly unconscious due to their cardiac arrest we can’t ask their permission. Also, due to the urgent need for treatment we are not able to ask a relative or friend, should there be anyone else present at the time, since this would delay the life-saving treatment that the patient needs.

We are aware of the sensitive nature of the circumstances in which patients will be included in the trial, and of the upset and distress that relatives will be in at such a difficult time. We have given careful consideration to the need for a compassionate approach to relatives, to reduce further distress, and have discussed this in detail with our patient and public research advisory group who fully support our approach to enrolling patients in this important study.

Research like this is considered lawful and ethical, provided it has been scrutinised and rigorously reviewed by several regulatory organisations including an ethics committee (which is a panel of medical, scientific and legal experts as well as representatives of the public) who review the research in terms of its importance to clinical practice and assess the risk and benefits of doing such a trial.

The trial is reviewed regularly by two independent monitoring committees, made up of representatives of the public and very experienced but independent medical and scientific experts in the field. These committees are able to stop the trial at any time if there are concerns about patient safety. Without research like this we would not be able to improve patient care in emergencies.

Why do you need so many patients to decide which treatment is better?

At the moment less than 10% of people who suffer an OHCA survive to leave hospital. Therefore even a very small improvement in survival (for example, increasing this figure by 2%) would be very worthwhile because an extra one in 50 people would be saved. There are well established statistical rules to determine how many patients are required to be sure that one treatment really does save extra lives at this level. These rules tell us that we need to enrol around 9,000 patients in the trial: 4,500 who initially receive the i-gel SGA and 4,500 who initially receive tracheal intubation. We will achieve these numbers by enrolling OHCA patients from four English ambulance services over two years.

What if one treatment turns out to be more effective, and you denied 4,500 people this option?

The reason we are undertaking this trial is because we really don’t know which approach to initial airway management is better during cardiac arrest, or whether they are more or less the same. At the moment people who have a cardiac arrest in England may get either treatment, and this is likely to continue until we can be sure which is the best approach. It is possible that once we have completed the trial we will be able to look back and say that some people should have been treated differently, but until we have done the study we have no way of telling what the best treatment is. 9,000 people (4,500 in each group) seems like a lot, but this is the fastest way of answering this important question, and improving the treatment that we are able to give to hundreds of thousands of patients in the future.

Our approach to this research is considered the ‘gold standard’, and provides the highest quality evidence to inform future guidelines for patient care. A good explanation of this can be found at the Testing Treatments website. http://www.testingtreatments.org/

Can patients opt out of the trial?

Because we are comparing two treatments that are already in routine use there is no specific opt out for this trial. However, if a relative or close friend, who happens to be present when the patient suffers a cardiac arrest, tells the paramedics that the patient previously said that they didn’t want to be in the study we will respect this, and the patient will not be enrolled.

When will the trial start?

The trial funding (and project as a whole) started in October 2014, and patient enrolment begins in June 2015, for a period of two years. Providing everything goes to plan, we will have a definite answer to this important research question within four years.