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Frequently Asked Questions

We appreciate you may have further questions about the trial. If your question isn’t answered on this page you can click here to submit your question to trial team.


+ 1. Why has this trial come about?

+ 2. Is experimenting like this on humans allowed? Is it legal to do this?

+ 3. What was the ethical justification for the trial?

+ 4. Did the study receive ethical approval?

+ 5. Why didn't you compare data on patients who currently have adrenaline and those who don't instead of doing this trial?

+ 6. Why was my relative entered into this trial without anyone’s permission or knowledge?

+ 7. I want to know what treatment my relative had.

+ 8. How did you cater for people who do not want to be part of the trial?

+ 9. What strategy did you use to inform relatives of those patients that did not survive?

+ 10. Who is the data controller for this trial? What data will be collected and how will my data be used?

+ 11. Will my participation in the trial be kept confidential?

+ 12. How can I withdraw from the trial follow-up?

About the Trial Protocol

+ 1. Why has this trial come about?

+ 2. Is it legal to do this?

+ 3. Adrenaline is known to increase return of spontaneous circulation, so why are you questioning the effectiveness of this drug?

+ 4. Why can’t you compare data on patients who currently get adrenaline and those who don’t?

+ 5. Why are you not using usual drug suppliers?

+ 6. Why are we using 3ml syringes rather than 10ml? Won’t it affect the results including generalisability?

+ 7. Do we have to do this?

+ 8. Can someone tell us what the results of the trial are?

+ 9. What if a patient’s relative starts asking me questions about the trial whilst I’m trying to resuscitate the patient?

+ 10. What if the hospital staff give adrenaline? Is there any point changing the out of hospital treatment?

Eligibility

+ 11. When should I use the trial drug pack?

+ 12. Why can’t the trial drug pack be used if the patient is ineligible?

+ 13. Why are children and pregnant women excluded?

+ 14. Is cardiac arrest caused by trauma an exclusion criterion for the trial?

+ 15. Is hanging an exclusion criteria for the trial?

+ 16. Should I use the trial drug pack even if I think the patient won’t make it?

+ 17. What if I am not the first vehicle on scene?

+ 18. Two vehicles arrive on scene simultaneously, one has drug packs and the other doesn’t which should be used?

+ 19. What if a St John Ambulance crew, doctor, nurse or CFRs arrive first and commence CPR?

+20. Why have you now excluded life threatening asthma when it was not excluded in the pilot phase of the trial?

+21. Are small doses of adrenaline given post -ROSC to maintain BP (as happens in London) still allowed if the patient is in the trial?

+22. Withdrawal of consent

+23. What should I do if I recruit a patient into the trial and part the way through the resuscitation I am told that the patient has hit an exclusion criteria? Eg is under the age of 16 and/or pregnant.

+24. What should I do if once resuscitation is terminated or handed over in hospital I find out my patient should not have been recruited? Eg is under the age of 16 and/or pregnant.

+25. The protocol says ‘adrenaline given prior to arrival of ambulance service clinician’ is an exclusion. Does this apply to ALL adrenaline (e.g. IM, Subcutaneous, Nebulised)?

+26. If a patient has received adrenaline for a cardiac arrest during a previous incident would this be an exclusion criteria?

Hospital

+ 27. What do you mean by out-of-hospital?

+ 28. Can resuscitation attempts be terminated on scene if the trial drug pack is being used?

+ 29. If the patient is taken to hospital what do I do with the trial drug pack?

+ 30. What happens when I get to hospital?

+ 31. What if a patient arrests on a hospital site? Can they still be in the trial?

+ 32. What if the patient is taken to a hospital in the area of another ambulance service?

Operational

+ 33. Can an ECA or technician open the trial drug pack for the paramedic to use?

+ 34. What equipment should I take with me to the patient?

+ 35. What if I need more than 10 syringes?

+ 36. If the patient rearrests, which drug should we use?

+ 37. What happens if more than one trial pack is used on one patient?

+ 38. What do I do with the unused syringes?

+ 39. Why can’t unused syringes be used on the next patient?

+ 40. What do I record on the PRF?

+ 41. What do I do if I suspect a serious reaction has occurred?

+ 42. The INCLUSION criteria states “Advanced Life Support initiated and/or continued by ambulance clinician.” Can the trial drug be given if the patient has IV/IO access but does not yet have an advanced airway in place?

+ 43. What are you doing to inform the coroners about the trial?

+ 44. What if my patient arrests en-route to hospital?

+ 45. What do I do if I find broken syringe(s)in the trial pack?

+ 1. How long has adrenaline been used and why is it only just being tested?

+ 2. What are the benefits of using adrenaline in cardiac arrest cases, how long has it been used and what evidence supports its use as part of the Advanced Life Support Algorithm?

+ 3. Is the PARAMEDIC-2 trial ethical?

+ 4. What ethical questions does this trial raise?

+ 5. The fact the study is asking whether adrenaline is cost effective raises further ethical questions if patient safety is at stake.

+ 6. Isn't this too high a risk to be making in such a, literally, life-or-death situation?

+ 7. How have you monitored that the current use of adrenaline in these circumstances is working or not?

+ 8. Some figures state that only 6% of the 50,000 in Britain who suffer a cardiac arrest in Britain outside hospital every year survive. There is also Japanese research finding that although it initially restarted their hearts, adrenaline actually reduced survival odds and increased the likelihood of brain damage. Do you know if these results are correct?

+ 9. What will the saltwater placebo actually do?

+ 10. If water [placebo group] were to be used in its place what effect could this have on patients despite the low chance of survival out of hospital? Could this put lives further in danger?

+ 11. How will paramedics know if someone has requested not to be involved in the Trial?


Paramedic 2: Adrenalin Trial

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TomQuinn




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If your question isn't answered on this page, please submit your question to the Trial Team.