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• W1992227474 abstract "Thank you for the opportunity to reply to Brad Quinn's letter commenting on our paper [1]. Firstly, we do not wish to get into a war of words. We evaluated the CobraPLA™ after an approach by Inspiration Healthcare, the potential U.K. distributors. When problems arose, these were reported to Inspiration Healthcare and Engineered Medical Systems (EMS). Despite this, relationships and lines of communication remained good. Unfortunately, we believe Mr Quinn's letter contains some inaccuracies and that it draws conclusions from published data that may be misleading. Quinn takes issue with the use of the CobraPLA™ for laparoscopy. He quotes Bapat's paper [2] as reporting aspiration in 1% during laparoscopy with a classic laryngeal mask airway. In fact the paper (enrolling 20% obese/morbidly obese patients and 14% with reflux) reported regurgitation in 1%. Regurgitation is not in itself harmful, aspiration is. There was no aspiration. Estimates of aspiration based on large databases or meta-analysis range from 1 in 4000 to 11 000 elective cases (including non-conventional use) [3–5]. Importantly, if one wishes to use a laryngeal mask with a reduced risk of aspiration the ProSeal™ is now available [6]. However, the issue here is not the risk of aspiration with the classic laryngeal mask airway but with the CobraPLA™. Mr Quinn states that the CobraPLA™ must not be used where a risk of aspiration exists. We believe such absolute statements (also used by other airway manufacturers), while understandable, are unhelpful. When isn't there some risk? Asai's recent editorial is relevant [7]. He commented that ‘aspiration is the key factor that will determine the future of supraglottic airways’. He stated that aspiration risk arises from patient, procedure and airway management factors and is virtually impossible to define pre-operatively. Even the starved patient with no risk factors may not to be safe. In a previous study we routinely inserted a gastric tube into 30 starved patients free of ‘risk factors’ for aspiration, undergoing elective surgery [8]. Gastric fluid was aspirated in 29 cases (median volume 22 ml, maximum 85 ml). There are no pre-operative clues to identify those patients with high gastric volumes. So, pragmatically, all patients are ‘at some risk of aspiration’ which we can only classify as high, medium or low risk. We considered both the patients in our series, who aspirated, to be low risk. However, concern about aspiration risk with the CobraPLA™ is based on two factors. First, device performance and second, device design. As the anaesthetist involved in both aspirations (T.C.) I found a 3% incidence of aspiration concerning. As discussed in our paper, even when correctly positioned the CobraPLA™ tip lies in the laryngopharynx, not at the oesophageal inlet. The tip of all other currently available supraglottic devices does reach, and therefore at least theoretically obturates, the upper oesophagus. The CobraPLA™ more closely resembles the (now withdrawn) COPA™ than other devices, an observation shared by Miller who classified supraglottic airways recently, recording the CobraPLA™ as a ‘cuffed pharyngeal sealer without esophageal sealing cuff’[9]. Under a ‘disadvantages’ section he commented ‘there is no sealing of the downward outlet into the oesophagus with the theoretical possibility of pumping air into the oesophagus during positive pressure ventilation. Reliance is solely placed on the tone of the gastrooesophageal sphincter. There is no protection from aspiration should passive regurgitation occur’. Mr Quinn's letter raises an issue central to the present proliferation of new airway devices and applying to virtually all manufacturers. He suggests that we ‘offer no evidence…that positive pressure per se was to blame’ and states that ‘after extensive internal review…we can find no scientific evidence’. The implication is that the responsibility lies with the user to prove lack of safety, rather than with the manufacturer to prove a degree of safety. We would prefer that statutory control demanded that the onus lay with the manufacturer. EMS state that during controlled ventilation with the CobraPLA™ the airway pressure should not exceed 20 cmH2O. There are three points: first, the initial pressure in both patients who aspirated was < 20 cmH2O. It only rose when the device appeared to rotate, causing misplacement and partial obstruction seconds before aspiration. Second, the website product instructions have changed since we started this study. Third, several publications have evaluated seal pressures well above 20 cmH2O [9–11]. In one EMS-supported publication, the seal pressure was above 20 cmH2O in 72% of cases (average 23 cmH2O, maximum 36 cmH2O) [10]. Gaitini reported a seal pressure of 33 ± 6 cmH2O [11]. In that study, gastric inflation was noted in 50% more CobraPLA™ patients than with a classic laryngeal mask airway (difference not statistically significant). Agro reported a seal pressure of 34.2 ± 2.8 cmH2O [12]. The higher seal pressure of the CobraPLA™ is a feature used to market the device. Mr Quinn does not appear to consider our statement that ‘we found no evidence to suggest the CobraPLA™ has significant advantages over the classic laryngeal mask airway’ to be important. However, even in a small incomplete study we found evidence of increased potential risk without likely benefit. Surely new devices competing with established equipment should offer a benefit in performance, safety or both. The cases that Mr Quinn quotes are case reports in which the CobraPLA™ was used and worked; these offer little evidence that the CobraPLA™ offers benefits over other airway devices. The CobraPLA™ is a new airway device seeking to find its place in anaesthetic practice. Data has been published on approximately 300 cases (mostly ASA 1–2 adults, with low body mass index and low aspiration risk). There is no published data on its use in infants or in obese patients. We find it difficult to reconcile the position adopted by EMS both being strongly against the use of the CobraPLA™ when there is ‘risk of aspiration’ and requiring airway pressures below 20 cmH2O, yet also promoting the device for use with controlled ventilation in neonates and patients exceeding 130 kg, in the absence of any published safety data. We have not suggested that the CobraPLA™ is unsafe, nor that it should be withdrawn on the basis of our findings. After all, the classic laryngeal mask airway received a mixed response when it was introduced, with more than one author raising concerns over aspiration risk [13]. However, in 1988 there was no acceptable, safe, alternative supraglottic airway. There are now several. We would caution against the use of the CobraPLA™ outside research until its safety, particularly during controlled ventilation, is established. Dr Cook has been paid honoraria for lecturing for Intavent Orthofix and the LMA company. Both these companies distribute laryngeal masks, competitors of the CobraPLA™. Dr Cook has received free equipment from Engineering Medical Systems, for performing the study described above. Engineered Medical Systems (EMS) appreciates the opportunity to reply to the issues raised by Cook & Lowe. Firstly, we stand by our statement that EMS does not advocate the use of CobraPLA™ for this procedure, as we believe that the nature of the surgery (increased intra-abdominal pressure and the need for increased airway pressure) places patients at increased risk for regurgitation and aspiration. As for the Bapat study [1], we believe that most clinicians would agree that when regurgitation occurs, there is a greater likelihood of aspiration. Second, we believe that advising clinicians against the use of these devices when a risk of aspiration exists is logically interpreted as ‘an increased risk’, as practitioners know that with virtually all medical procedures and interventions a risk of zero does not exist. We further believe, as Asai's editorial [2] points out, that one must be mindful of patient factors, operation factors and anaesthetic factors when assessing for increased risk of aspiration. At EMS, we continue to advocate erring on the side of caution and the use of common sense. Third, Cook cites the design of the CobraPLA™ as putting patients at risk for aspiration and notes the COPA™ having a similar design in terms of cuff location, further noting that the COPA has been withdrawn from the market. The implication of this observation is that a product such as CobraPLA™ with a cuff location similar to that of the COPA™ might be unsafe and thus might need to be withdrawn from the market as well. It is our understanding that the COPA™ was withdrawn due to poor sales and not for safety reasons. Indeed, a search of PubMed using ‘COPA’ lists 229 articles, while a search under ‘COPA and aspiration’ lists only 3, none of which documents a single case of aspiration. It is true that the CobraPLA™ does rely on the integrity of anatomic sphincters (as does the use of a facemask when delivering positive pressure ventilation) and proper use by the practitioner to avoid regurgitation. Cook is incorrect in stating that the tip of the CobraPLA™ does not reach the oesophageal inlet (Fig. 1). However, given that there is no distal cuff on the CobraPLA™, the integrity of the oesophageal sphincter is likely not violated, a condition that we believe is favourable to the safety of the device. Indeed, when using a laryngeal mask airway oesophageal incompetence might be the culprit for the high incidence of regurgitation found immediately after its removal, rendering a temporarily incompetent sphincter unprotected by the ‘blocking’ effects of the previously lodged laryngeal mask airway [3]. Interestingly, a recent abstract presented at the International Anaesthesia Research Society which compared the CobraPLA™ with the laryngeal mask in mechanically ventilated paediatric patients found less gastric insufflation in the CobraPLA™ group [4]. In a presentation at the same meeting, Ezri et al. [5] found a similar incidence of gastric reflux in mechanically ventilated patients (as indicated by continuously measured hypopharyngeal pH levels) in whom the CobraPLA™, the Fastrach and the ProSeal were used and a higher incidence of gastric reflux with the LMA Classic™, COPA™, and laryngeal tube. MRI of CobraPLA in-situ in child, showing the outline of the device and its anatomic location. Fourth, we agree with Cook that manufacturers have a responsibility to assure regulatory agencies that their products are safe for use. In that regard, the CobraPLA™ has full approval for use in the United States, the European Union, Japan, Korea, Australia, Mexico, Malaysia, South Africa, and many other countries around the world. In fact, no regulatory agency has ever denied its use. Fifth, it is correct that EMS implicitly states on its website and in its product literature that practitioners should limit positive airway pressure to less than 20 cmH2O and that this warning reflects a modification of the initial literature at product launch. We will continue to modify and amend instructions for use as the need dictates. Cook is critical of the fact that three clinical studies [6–8] utilised seal pressures greater than 20 cmH2O, but the study designs were entirely under the control of the investigators. It is reassuring to us, however, that even with use that Cook is highly critical of, the results were favourable to the CobraPLA™ and that all patients did well. EMS does and will continue to feature the higher airway seal pressures that are reliably achieved with the CobraPLA™ as a positive marketing advantage of the product, as we believe that if a clinician desires to use positive pressure ventilation in a controlled manner having a seal that can consistently be achieved is desirable. Sixth, Cook again states a lack of any advantage of CobraPLA™ over the laryngeal mask airway or other supraglottic devices. We can offer the following: When used as a conduit for fiberoptic intubation it allows the practitioner to insert the cuff of a standard (length) tracheal tube all the way through the vocal cords, thereby obviating the need to remove the CobraPLA™ after securing the airway [9]. Use of the CobraPLA™ in the larger sizes (CobraPLA™ sizes 4–6) allows passage of up to a size 8.0 standard tracheal tube [9]. It is easier to insert into patients than the laryngeal mask airway, as there is no need for airway manipulation. This is advantageous in situations such as neck instability [10]. It provides consistently higher airway (cuff) seal than does the laryngeal mask airway [6–8]. It is more stable in infants due to the relatively flat ‘Cobra-head’ which lies against the posterior hypopharynx and thus does not allow rotation [4]. The laryngoscopic views through the CobraPLA™ are superior to those obtained when using the laryngeal mask airway in paediatric [4] or adult [7] patients. The CobraPLA™ can function as an alternative for the laryngeal mask airway in cases where use of the laryngeal mask airway has failed to provide for a procedure to be performed [11] or when insertion of the LMA has proved impossible [10]. In addition, the CobraPLA's advanced monitoring abilities in all sizes will launch this fall, again a feature unique among supraglottic airways. No advantages? Seventh, Cook cautions against use of the CobraPLA™ in mechanically ventilated patients except during patient research, partly due to ‘no published data on its use in infants’, a situation that is clearly made in error [4, 11–13]. Is Cook able to explain how at least one prominent academic paediatric hospital in the United States (Denver Children's Hospital) has been able to successfully use the CobraPLA™ as its supraglottic airway of choice for the past 2 years without major complications and to present research regarding its safe use in infants and children [13]? Does he offer a single bit of scientific evidence as to why ventilatory pressures under 20 cmH2O are unsafe in any circumstance (including use of a face mask), let alone with the CobraPLA™? In conclusion, we respect Dr Cook's many contributions to the scientific literature, and we believe his intentions are admirable and made solely in the interests of patient safety. However, as evidenced by the above points, we respectfully disagree with his conclusions, and we believe the CobraPLA™ to be a safe and advantageous supraglottic airway when used properly. This correspondence is now closed –Editor." @default.
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• W1992227474 title "More on the CobraPLA" @default.
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