Anaesthesia Blog, April 2016.
Ella Fitzgerald, Little Richard and Bananarama all famously sang “It ain’t what you do it’s the way that you do it”, and the May edition of the journal reinforces this in several ways.
The first example of this is a fascinating and shocking editorial about sugammadex that has important lessons for all of us who undertake (or take part in) research, audit and service evaluations in our institutions. The authors describe how they determined that a proposed study was a service evaluation and registered their study with their institution, but did not seek formal ethical approval, as advised under recommendations for service evaluations in the NHS, and did not gain patient consent or even discuss participation in the study with their patients. After ENT surgery, they exchanged the tracheal tube for a laryngeal mask, and then administered sugammadex to reverse neuromuscular blockade; the first two patients in their study then developed sudden and dramatic airway obstruction. The study team decided to investigate this further by performing fibreoptic endoscopy through the laryngeal mask on the next three patients and saw that the vocal cords were completely closed following sugammadex administration, a totally unexpected finding that had not been described in the literature before at this point. However, the key point was that they didn’t discuss this and other protocol changes with anyone else, namely their institution or more importantly, the patients themselves. They also didn’t report the adverse events locally. The Editor-in-Chief at the time of submission of the resulting article (Professor Yentis) contacted the authors, and eventually the local ethics committee, and a formal investigation into their ethical conduct resulted. Finally, the patients who took part in the study were contacted, and all agreed that data arising from the study could be published.
There are numerous lessons to learn. What someone thinks is a service evaluation or audit may be much closer to a research study in the opinion of others, and Professor Yentis, in his accompanying commentary, argues that study protocols should be discussed with an ethics committee in many more cases, if not routinely, and prospective patient consent sought. The journal receives numerous submissions where there is doubt about the ethical conduct of the study, and one of the commonest questions I am asked is “Do I need formal ethical permission?” Perhaps the new NHS system of all applications for studies in England (including audits and service evaluations) needing to apply for HRA approval (see http://www.hra.nhs.uk/research-community/applying-for-approvals/) will sort this conundrum out once and for all? From the journal point of view, we expect to change our guidelines to authors and insist that HRA approval has been granted before starting any study from April 2016 – more about this to follow.
What about the actual findings of the work of these authors? Well, these are interesting and quite novel. The adverse effect of sugammadex, namely that it may lead to airway obstruction if given to patients who do not have a tracheal tube in situ, due to vocal cord closure, is important and should be communicated to the anaesthetic community who have started to embrace sugammadex into their more mainstream practice recently, hence the decision to publish the account of this study as an editorial. The way the authors conducted the study may have been flawed, without formal ethical approval or patient consent, but the lessons from their conduct and work still need to be learnt.
There has been much debate in the literature about anaesthetic technique for surgery following fractured neck of femur, between general and spinal anaesthetics (with or without nerve blocks). An excellent article, which analysed the data from over 16,000 operations carried out in 2013 as part of the Anaesthesia Sprint Audit of Practice (ASAP-1), is published in this month’s journal. The overall message I took from this article was that the type of anaesthetic technique (GA or spinal) did not affect mortality, but how, and with what degree of care, especially with regards to blood pressure, the anaesthetic was provided, did matter. On one hand, this is not that surprising – we know that anaesthesia is a craft specialty, and how you give an anaesthetic is important, as demonstrated so eloquently in this article. On the other hand, the lack of a difference between the two major choices of technique (at least with respect to mortality), is surprising, as so many anaesthetists have polarised views one way or another. The question about whether the study design may have affected the findings is also an important one, as discussed in the accompanying editorial. The argument over the relative advantages and disadvantages between large observational studies, such as ASAP-1, and randomised controlled trials (the current so-called gold standard for level of evidence) will no doubt rage on, but in the meantime, the evidence we have is that conduct of anaesthesia is more important than actual technique with regards to mortality after fracture neck of femur. In other words, how you give your anaesthetic, not what anaesthetic you give.
Finally, the first guidelines for safe vascular access are published in May’s edition of the journal. This lists some very important recommendations that I believe will shape our practice with regards to vascular access for years to come. Vascular access, be it peripheral, central or arterial, is the most common invasive procedure carried out in hospitals, and if carried out with care and attention, and with meticulous aftercare, is safe. These guidelines recommend more widespread/earlier use of ultrasound, more formal training and supervision, better systems (including specific policies regarding safety and proficiency), all with the aim of improving safety, effectiveness and timeliness of all vascular access. Remember, it’s the way that you do it (and look after it, in this case), that’s important.