B J A B r i t i s h J o u r n a l o f A n a e British Journal of Anaesthesia s t h e s Editor-in-Chief: Charles S. Reilly i a S o SOUTH AFRICAN u t EXCERPTS EDITION h A f r Volume 12 Number 3 2012 i c a n E x c e r p t s E d i t i o n V o l u m e 1 2 • Status of national guidelines in dictating N u m individual clinical practice and defining b e negligence r 3 2 0 • High STOP-Bang score indicates a high 1 2 probability of obstructive sleep apnoea p a g e s • Impact of phenylephrine administration 1 0 1 on cerebral tissue oxygen saturation and - 1 5 blood volume is modulated by carbon 6 dioxide in anaesthetized patients M e d S p e c P u b l i s h i n g 101 BJA EXCER PTS SOUTH AFRICAN EDITION Publisher Reni Rouncivell Tel: (012) 661 3294 / Fax: 086 561 5122 Cell: 082 441 6904 [email protected] Guest Comment Advertising Lelani Adendorff Prof Mike James, the editor of this Journal has requested that I write the editorial Cell: 079 512 6990 while he is undergoing his medical therapy. I am joined by the entire readership of [email protected] the Journal and all the members of the South African Society of Anaesthesiologists Subscriptions & Accounts in wishing him well and we trust that he will make a speedy recovery. Elizabeth Versteeg Cell: 072 189 8499 We are all aware of the emergency situation where rapid sequence intubation is [email protected] mandatory. We are equally aware that even with the best intention that we may Private Bag X1036, Lyttelton encounter a situation where intubation becomes impossible. All anaesthesiologists South Africa 0140 are familiar with succinylcholine and all are aware of its advantages and For address changes please contact: disadvantages. Many studies have been performed to try and obtain the same Cally Lamprecht: [email protected] ideal intubating conditions as those obtained when using succinylcholine. Using other agents including vecuronium and rocuronium, we were not able to obtain complete paralysis in the same time as that obtained using succinylcholine. Furthermore, should intubation not have been possible then we had the problem © The Author. Published by Oxford University Press on behalf of the British Journal of Anaesthesia of a paralysed patient with no airway control. The consequences of such a set of This Specialized Edition is subject to copyright. All circumstances could prove fatal. rights are reserved, whether the whole or part of the material is concerned, specifically the rights We in South Africa do not yet have sugammadex available. The question that is for translation, reprinting, reuse of illustrations, being asked is whether reversal of non-depolarising neuromuscular blocking agents broadcasting, reproduction on CD-ROM, microfilm, online publication, storage in data banks or in any can be rapidly reversed by sugammadex during a rapid sequence induction when other way. intubation proves difficult. This exact question has been examined by Sorensen This Specialized Edition contains selected items et al. It would appear that time to reestablishment of spontaneous ventilation is originally published in the British Journal of Anaesthesia (“BJA”) and is published by arrangement longer when succinylcholine is used than when the rocuronium-sugammadex with the British Journal of Anaesthesia on behalf of combination was used. We should note that no mention is made of intubation the Journal and its publisher Oxford University Press. The Chinese Society of Anesthesiology (“CSA”) conditions when the rocuronium was used but we know that they will not be as has obtained the permission of the British Journal good as the neuromuscular blockade obtained when using succinylcholine. of Anaesthesia and OPL to publish the Chinese language Specialized Edition of BJA to distribute to Another topic of great interest is the period of starvation for infants prior to medical professionals within China. induction of anaesthesia. It is fairly well accepted that clear fluid can be given to No part of this Specialized Edition may be reproduced, electronically or mechanically, including children up to two hours prior to anaesthetic induction for elective surgery. Exactly photocopying, resending or in any information how much fluid remains a subject of debate. We also know that sugared clear fluid storage and retrieval system, or transmitted in any form, by any means, without prior written permission is being used both as a pacifying agent and to prevent hypoglycaemic episodes. from OPL and the British Journal of Anaesthesia. The questions arise as to how much fluid may we give and when should this Please send any permissions/reprint requests to: fluid be given. A Schmitz et al have attempted to determine the effects of different [email protected] volumes of sugared fluid on gastric emptying and residual volumes in children. The use of registered names, trademarks etc within this Specialized Edition does not imply, even in the The study allowed for fluid to be administered one hour prior to induction. We absence of a specific statement, that such names are should note that the gastric emptying rate was similar for the different ingested exempt for the relevant laws and regulations and volumes. Equally notable is the fact that residual gastric volumes were significantly therefore free for general use. Although great care has been taken in compiling the less when 3 mg/kg of fluid was given when compared with 7mg/kg. This is a content of this Specialized Edition, neither OPL nor small study and the subjects were children of school-going age as cooperation the British Journal of Anaesthesia are responsible or of the children was required for the MRI studies. The results are not necessarily in any way liable for the accuracy of the information, for any errors, omissions or inaccuracies, or for any extrapolatable to neonates and small infants. consequences arising therefore. CSA is the sole entity responsible for the content published in the Finally we should take note of the editorial by Fearnley, Bell, and Bodenham. Specialized Edition. They, using case reports, highlight the potential problems of our dependence on The publication of an advertisement in this guidelines for practice. Many of these guidelines are not applicable to medical Specialized Edition does not constitute on the part of OPL and the British Journal of Anaesthesia a practitioners around the world as they are “created” for specific health care systems guarantee or endorsement of the quality or value of and specific countries. These guidelines do not consider specific clinical situations the advertised products or services described therein or any of the representations or the claims made that we may encounter in our everyday practice of anaesthesia in South Africa. by the advertisers with respect to such products or Our patients demand that we do what is best for them and not necessarily what services. No responsibility is assumed by OPL for any injury and/or damage to persons or property as some foreign guideline demands. Failure to comply with some of these guidelines a result of any actual or alleged libellous statements, would not be deemed as negligent practice in South Africa. infringement of intellectual property or privacy rights, or products liability, whether resulting from negligence or otherwise, or from any use or operation Dr. Milton Raff of any ideas, instructions, procedures or methods BSc (WITS), MBChB (Pret), FFA (SA) contained in the material therein. BJA EXCERPTS SOUTH AFRICAN EDITION VOLUME 12 NUMBER 3 2012 110022 104 BJA E X C E R P T S SOUTH AFRICAN EDITION Volume 12 Number 3 2012 CONTENTS EDITORIAL I Status of national guidelines in dictating individual clinical practice and defining negligence 106-110 R. A. Fearnley, M. D. D. Bell and A. R. Bodenham CLINICAL PRACTICE 113-120 High STOP-Bang score indicates a high probability of obstructive sleep apnoea F. Chung, R. Subramanyam, P. Liao, E. Sasaki, C. Shapiro and Y. Sun NEUROSCIENCES AND NEUROANAESTHESIA 122-129 Impact of phenylephrine administration on cerebral tissue oxygen saturation and blood volume is modulated by carbon dioxide in anaesthetized patients L. Meng, A. W. Gelb, B. S. Alexander, A. E. Cerussi, B. J. Tromberg, Z. Yu and W. W. Mantulin 131-137 Reduced cerebral oxygen saturation during thoracic surgery predicts early postoperative cognitive dysfunction L. Tang, R. Kazan, R. Taddei, C. Zaouter, S. Cyr and T. M. Hemmerling PAEDIATRICS Effect of different quantities of a sugared clear fluid on gastric emptying and residual volume in children: 139-142 a crossover study using magnetic resonance imaging A. Schmitz, C. J. Kellenberger, N. Lochbuehler, M. Fruehauf, R. Klaghofer, H. Fruehauf and M.Weiss RESPIRATION AND THE AIRWAY 145-152 Rapid sequence induction and intubation with rocuronium–sugammadex compared with succinylcholine: a randomized trial M. K. Sørensen, C. Bretlau, M. R. Gätke, A. M. Sørensen and L. S. Rasmussen For any reference/citations from this selection of items, the source must be given as the original article with full bibliographic detail as given at the top of the first page of each article 106 Volume 108, Number 4, April 2012 BritishJournalofAnaesthesia108(4):557–61(2012) doi:10.1093/bja/aes092 EDITORIAL Status of national guidelines in dictating individual clinical practice and defining negligence R. A. Fearnley1, M. D. D. Bell2 and A. R. Bodenham2* 1DepartmentofAnaesthesia,KingsCollegeHospital,London,UK 2DepartmentofAnaesthesia,TheGeneralInfirmary,LeedsLS13EX,UK *E-mail:[email protected] Witha majoremphasis on patientsafety, clinicalpractice is an unremarkable early recovery and was discharged home increasingly undertaken in a setting of guidelines from a aweeklater. range of advisory and regulatory bodies. Concerns remain Six weeks after surgery, the patient attended for routine about the survival of clinical discretion in the face of such follow-up and complained of tinnitus in her right ear and a directives,withuncertaintyastotheirvalidityandauthority, persistent headache. She later developed a sensation of and reservations as to potential adverse consequences. The blood rushing in both ears and a neurology review some 5 role of such guidelines in defining negligence is also months after surgery revealed a loud bruit and palpable unclear, and it is this element which provides the trigger thrill at the base of her neck. Cerebral angiography demon- for thiscommentary. strated a fistula between the vertebral artery and internal To illustrate this conflict between clinical practice and jugular vein, involving the cervico-vertebral venous plexus. guidelines, we report the case of a complication of central A small left occipital infarct was seen on brain computed venous catheterization using a landmark-based technique. tomography, which was considered likely to be related to Thisincidentoccurred2yrafterthepublicationofNICEguid- thefistula, eventhoughit was onthecontralateral side. ance recommending the routine use of ultrasound for this An interventional radiology opinion was sought and the procedure.1 This rare complication of vascular access patientunderwentsuccessfulvertebralarterystentocclusion resulted in a civil claim, raising important questions on the of the fistula under local anaesthesia.2 The patient was left statusofnationalguidelinesindefiningmedicalnegligence. with a small visual field defect but all other symptoms In 2004, a 42-yr-old female was listed for breast recon- resolved. Monthslater, aclaimfordamages wasissued and struction surgery. At preoperative anaesthetic assessment, expert medical opinions were commissioned both for the the patient was informed of an indication for central Claimant and defending hospital. None of the authors of venous access and the risk of pneumothorax was both dis- thispublicationwasinvolvedwiththeoriginalclinicalproced- cussed and documented. After induction of general anaes- ure,althoughone(A.R.B.)assistedwiththehospital’sinternal thesia, catheterization of the right internal jugular vein was investigation. attempted using a landmark approach, by a consultant an- aesthetist who documented that the internal carotid artery Legal claims: breaching the medical was hit on the first pass of the 18 G introducer needle. No duty of care, establishing harm, additional instrumentation was performed and direct pres- and establishing causation sure was applied over the insertion site for 10 min. Surgery and anaesthesia continued uneventfully and no immediate Establishing medical negligence and successful litigation postoperative complications were noted. The patient made requires that three key criteria should be satisfied. &TheAuthor[2012].PublishedbyOxfordUniversityPressonbehalfoftheBritishJournalofAnaesthesia.Allrightsreserved. ForPermissions,pleaseemail:[email protected] 107 BJA Editorial The Claimant mustfirstbe owed a dutyof care, established Consent whenever a patient undergoes treatment, and rarely con- It was argued that the rarity of this particular complication tested. Secondly, a breach of that duty of care by a failure meant that it could not have been reasonably anticipated to provide a required standard of medical care must be and it was correspondingly reasonable not to list it during established. Thirdly, as a direct result of that breach, the theconsent process. Claimant must have suffered physical or psychological harm, orothertangible losses. An invitation to pass judgement At this juncture, we invite the reader to consider the legal Principal arguments for the Claimant arguments made above and come to a conclusion as to which opinion they would adopt if invited as an expert Causation witness or whom they would find in favour of were they to TheClaimantpointedoutthattherewasacleartemporalre- be passing judgement. As an additional point of interest, lationship between the development of the symptoms and the authors also invite the reader to consider whether their needle placement in an artery in the neck. There were no position would differ if the incident had occurred in 2011 other plausible causes for the arterio-venous fistula, which rather than2004. is a rare but recognized complication of such procedures.3 It was argued that had ultrasound guidance been used, Legal aspects of the Defence: the Bolam principle then on the balance of probabilities, the arterial puncture and beyond and itssequelaewould have been avoided. TheDefenceofthiscaseisgroundedprimarilyupontheen- duringBolamprinciplewherebythedoctorisnotliableforhis Breach of duty diagnosis, treatment, or refusal to give information to the The Claimant stated that the attending anaesthetist should patient, if he follows a responsible body of medical have utilized ultrasound guidance to ensure first-pass opinion.5 The actions of the anaesthetist were correspond- needle insertion into the jugular vein, while avoiding ingly defended on the grounds that his practice was in damage to vulnerable adjacent structures. Such practice keeping with that of a large number of UK anaesthetists at should,itwasargued,havefollowedtheUK(2002)NICEna- the time of the incident, and this had not hitherto been tionalguidancerecommendingtheroutineuseofultrasound legally or otherwise defined as ‘irresponsible’. Practical guidanceforinternal jugularcatheterization.Astheproced- reasons for a widespread failure to implement and follow ure in question took place some 2 yr after release of this NICEguidance at the time of the event were alsovoiced by guideline, the Claimant arguedthatsuch techniques should thedefenceteam. have been in routine use in a major teaching centre by this ModificationoftheBolamprinciplebythecaseofBolitho time.Thereweredelaysinrecognizingthediagnosisatsurgi- is however an important consideration as opinion within cal follow-up, but this was not pursued by the Claimant’s thatjudgementdemonstrates;‘itisnotenoughforadefend- legal team. The issue of the patientnot being consented to anttocallanumberofdoctorstosaythatwhathehaddone the possible risk of vascular injury during attempted central or not donewas in accordwith acceptedclinicalpractice... venous cannulation was also not specifically raised by the The court must be vigilant to see whether the reasons Claimant. given for putting a patient at risk are valid...or whether theystem from a residual adherence to out of date ideas’.6 Given that percutaneous central venous cannulation may Arguments by the defending hospital be associated with mechanical complications in up to 5– Causation 19% of the patients and accurate needle tip guidance with real-time two-dimensional ultrasound should theoretically Thiswasnot disputedbythe defending hospital. make the complication seen in this case entirely avoidable, legal deliberations would focus on whether a failure to use Breach of duty ultrasound places patients at unnecessary risk. To quote The Defence contested breach of duty. It argued that while JusticeReynoldsinthecaseofAlbrightonvRoyalAlfredHos- NICE guidelines had indeed been published 2 yr before the pital;‘Itisnotthelawthatifallormostofthemedicalprac- incident, and implementation of such guidance is supposed titioners in Sydney habitually fail to take an available to be in place within 3 months of publication, the clinical precautionto avoid foreseeable riskofinjury tothepatients reality was much more complex. The anaesthetist’s chosen thatnonecanbefoundguiltyofnegligence’.7Suchdelibera- approach was a recognized technique, the one he was tions would of course be made more convoluted were most familiar with and therefore the technique that would attempts to follow an ultrasound-guided technique to be expected to minimize the risk of harm to the patient. result in injury if concerns existed about the adequacy of His practice was also in keeping with a significant number training in this technique.8 Rather than simplistically apply- of anaesthetists at the time of the event4 and thus, it was ing the Bolam principle therefore, it is likely that the Courts argued,didnot constitute abreachof duty. will seek to interpret and appraise the authority and 558 108 BJA Editorial applicability of newly issued guidelines in the context of failure to maximize patient safety according to the current current practice as described by expert witnesses, an add- levelsofevidence. itional variable expanded upon below. Should discrepancies exist between what was done and what could or should Implementing guidelines: time, training, have been done, practitioners can anticipate that the Court funding, and other obstacles would predictably align itself with a clinical approach that minimizestheriskofpatientharm. The defending Trust in this particular case highlighted a number of practical obstructions to the timely implementa- tionoftheNICEGuidance.Theassertionthatnoveltherapies Additional points ofreferenceforassessing or guidelines cannot be implemented immediately was first given legal significance in the case of Crawford v Board of medical competence, performance, Governors of Charing Cross Hospital where the presiding and conduct Lord Justice Denning stated: ‘it would be quite wrong to While the Bolam principle remains a benchmark for the suggest that the medical man is negligent because he Courts, it is important to acknowledge that as clinical prac- does not at once put into operation the suggestion that tice within anaesthesia changes over time, the threshold some contributor or other might make in a medical for ‘acceptable clinical practice’ will continue to evolve. journal’.11 The case before Lord Justice Denning was by no Given such evolution, establishing ‘acceptable practice’ in means identical to the case that we are considering but all but the most extreme cases may be challenging, the concept ofnewideas, evidence, orguidance requiring a lengthy, and destructive for both Claimant and Defendant. periodoftimefordisseminationandintegrationintoclinical Additional points of reference for the more equivocal cases practice is an important one. In the UK, the NHS has been maybesoughtfromthevariousregulatoryandprofessional directed by the Secretary of State to provide funding and bodies established to promote patient safety and maintain resources to facilitate the implementation of guidance professional standards within anaesthesia and critical care. issuedbyNICE,throughitsTechnologyAppraisalProgramme. DespitetheresponsibilitiesoftheRoyalCollegeofAnaesthe- The recommendation is that this should occur within 3 tists, the Association of Anaesthetists of Great Britain and months of the publication of such guidance. Extensions to Ireland, the National Institute for Health and Clinical Excel- this may be granted by the Secretary of State on advice lence,theNationalPatientSafetyAgency,oranyoftheinnu- from NICE but to date this has only occurred in relation to merable societies associated with specialist areas of about 10% of the technology appraisals issued.12 The anaesthesia, the professional standards set out by such realityisthatfundingtoallowacquisitionofnewequipment bodies through the publication of guidelines are in the and staff training must be obtained through savings else- main not comprehensive, unambiguous, or prescriptive. where. The need for structured training and assessment of Even the application of the fundamental principles under- personnel involved in the use of new technology is clearly lyinggoodmedicalpracticeandexpectedofanydoctorregis- an additional obstacle to rapid implementation. This final tered with the General Medical Council demands only that point is deserving of slightly closer attention and is clearly the standard of care and practice should be ‘good’ rather more applicable to some forms of technology than others. thanofthe‘highest’standard.9Itisseenthereforethatref- The learning curve and operator dependence in the use of erencetosuchprofessionalstandardsmaynotunequivocally pulse oximetry or end-tidal CO monitoring is much less 2 establish whether the care provided by a practitioner was thanthatassociatedwiththeuseofultrasoundforvascular merely suboptimal or whether it had fallen below a reason- access procedures or the performance of nerve blockade. ableoracceptablestandard.Itisbecauseofthisequivocation While logically much greater time and expense would be that the processing of anegl igence claim is predominantly required to achieve competency in the latter, acknowledge- opinion-based and thus, predictably adversarial, protracted, ment of the huge differences in training required to deploy and expensive. In relation to that opinion, it has to be different forms of technology and subsequent allowances acknowledged that a partisan approach byexpert witnesses of increased time for institutions to get ‘up to speed’ can contribute to those negative sequelae, and despite seems to be lacking. But how much delay is acceptable? It recent publicity as to the emerging accountability expected is difficult to be authoritative asthe concept of significantly of experts,10 it is predictable that without more stringent delayed implementation of guidance is not new within the scrutiny of this aspect of professional activity, the spectrum NHS.ThreeyearsafterthedeathofayounggirlintheAcci- of ‘conduct, competence, and performance’ in this field will dent and Emergency Department of a London Hospital in compromise both the pursuit of justice and endorsement of 2000 from a hypoxic gas mixture, a survey identified 25 improved standards of care. We raise the question as to Trusts that were still using anaesthetic machines that were whethertheabsenceoftrulyprescriptiveguidancefrompro- non-compliant with the relevant Patient Safety Alert.13 Ul- fessionalbodiesconcerningsomekeyareasofpractice,such timately, a degree of risk analysis is clearly required, but astheuseofultrasoundguidanceforcentralvenouscannu- any absolute failure to implement high-impact guidance lation,isanacceptablesituationorwhetherthisperpetuates concerning clinical practice that may result in significant the scenario described above and represents a systemic morbidity or mortality should be viewed as indefensible 559