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• W2022772223 abstract "We are grateful for Dr Pandit’s interest in our paper [1, 2]. He raises a number of relevant and important points. While Dr Pandit’s main point is clearly statistical, some parts of the editorial may be construed as potentially critical of our paper and therefore we respond here to expand the rationale behind our, perhaps controversial, paper. He explores the ethics of the paper using, as a benchmark, the fact that rapid sequence induction (RSI) was not used. We agree that the article is controversial and of course as authors we carefully considered the ethics of the study. It is important to note that in the Spanish hospital where this study was performed the Proseal Laryngeal Mask AirwayTM (The Laryngeal Mask Company, St Helier, Jersey, UK) is used for selected non-elective work and use of a supraglottic airway (SAD) for selected appendicitis cases is standard practice. The assumption, which some readers may read into the editorial, that RSI is a benchmark, is interesting. A recent systematic review found no robust evidence for efficacy of RSI reducing aspiration incidence [3]. RSI is poorly defined, and considerable variation exists in timing and application of cricoid pressure, the choice and dose of drugs and the timing of their administration [4]. In the same issue of Anaesthesia as Dr Pandit’s editorial, the abandonment of cricoid pressure, the central plank of RSI, is advocated [5]. Intubation has inherent risks and we believe unnecessary intubation should be avoided where appropriate alternatives exist. In contrast, the editorial appears to promote a culture where ‘intubation is king’. The description of the tracheal tube as airway gold standard, is based on supposition rather than experimentation and progress in SAD technology challenges this. The tracheal tube is an imperfect airway with most weaknesses relating to invasiveness and complications of intubation/extubation. There are clear advantages to avoiding intubation where it is not necessary: the only difficulty is defining those circumstances. For low risk appendicectomy the only reason not to use a SAD is the presumed risk of aspiration. However the risk of aspiration during appendicectomy without airway management, with a ‘standard’ SAD or with an advanced SAD is unknown, as appropriate studies have not been performed. Our study is a first small step in determining this. The evidence of increased incidence of aspiration with the LMA-Classic compared to the tracheal tube in elective patients is scant. Warner [6] estimated an incidence of aspiration via a tracheal tube of 1 in 4000 for elective surgery, with two thirds occurring during placement or within 5 min of extubation. While aspiration around a cuffed tracheal tube is rare [7], perhaps manipulations of the tracheal tube may cause aspiration. The incidence of aspiration with the LMA-Classic is lower than the above figures [8]. Science involves questioning the status quo. There is no practical way of determining if it is reasonable to use the Proseal Laryngeal Mask AirwayTM in selected cases of suspected appendicitis without actually trying it. As such our paper is potentially groundbreaking, as it is the first description of a significant series where a SAD was chosen for emergency surgery, rather than used as a rescue device. We accept that this challenges some preconceived ideas but we are not alone in that: in the same edition of Anaesthesia, Yentis and Calder [9] continue to challenge the dogma that ventilation must be confirmed before administering muscle relaxants and Clarke [10] questions the assumption that the tracheal tube is the safest airway in an unconscious patient in the pre-hospital environment, surely a group with at least as high a risk of aspiration as carefully selected patients for appendicectomy. We agree that simply deciding to use a SAD for appendicectomy ‘on a whim’ would be irresponsible and unethical. However if considerable evidence supports the view that a specific device has advantages, it might be considered perverse not to explore the potential benefits of expanding its indications. Such evidence does exist for the Proseal Laryngeal Mask Airway [11–13]. As such we consider the study is not irresponsible and that the Proseal Laryngeal Mask Airway is the only SAD for which this is currently the case. SADs avoid many complications of tracheal intubation, provide smoother emergence, and there is evidence that use of the Proseal Laryngeal Mask AirwayTM may improve analgesia [14]. These are all potential patient benefits, but without studies such as the one we have conducted the evidence base for this is at best implicit. Regarding the statistical uncertainty of our results we agree wholeheartedly with Dr Pandit that the absence of observed major complications in a series of 102 patients is not proof of safety [15]. Dr Pandit explains that an incidence of 0/102 has a 95% confidence interval (CI) upper limit of around 3%, but then states, ‘even one case of aspiration would have implied an unacceptably high prevalence of aspiration of ∼1%’. Well, yes and no. This is a ‘point estimate’ and CIs have lower as well as upper limits. The lower limit of 0/102 is of course 0% and the lower limit of the 95% CI of 1/102 is 0.02%. So while statistical uncertainly is important, perhaps we should also remember the simple fact: in our study there were no major complications in 102 patients and no episodes of regurgitation or aspiration. Finally we believe it is foolhardy to base a major change in practice on a single paper and certainly this is true of our paper. We would not advise that any clinician abandon RSI on the basis of our paper. However we hope that clinicians will continue to challenge orthodoxy in carefully designed, ethically approved and meticulously performed studies. Dr Cook has received payment for lecturing for Intavent Orthofix and the LMA Company, both distributors of the Proseal LMA. He has also received reduced cost or free equipment for research from these companies and their competitors. No author has any financial interest in any of these companies or their products." @default.
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• W2022772223 title "Comments on a statistical note on the Poisson (binomial) distribution" @default.
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