New guidelines for research in airway device evaluation: time for an updated approach (ADEPT-2) to the Difficult Airway Society's 'ADEPT' strategy?

In this article we present the learning from a clinical study of airway device evaluation, conducted under the framework of the Difficult Airway Society (DAS, UK) 'ADEPT' (airway device evaluation project team) strategy. We recommend a change in emphasis from small scale randomised controlled trials conducted as research, to larger-scale observational, post-marketing evaluation audits as a way of obtaining more meaningful information.

Assessing a novel second generation laryngeal mask airway using the 'ADEPT' approach: results from the LMA® Protector™ observational study.

To address the problem of lack of clinical evidence for airway devices introduced to the market, the Difficult Airway Society (UK) developed an approach (termed ADEPT; Airway Device Evaluation Project Team) to standardise the model for device evaluation. Under this framework we assessed the LMA Protector, a second generation laryngeal mask airway. A total of 111 sequential adult patients were recruited and the LMA Protector inserted after induction of general anaesthesia. Effective insertion was confirmed by resistance to further distal movement, manual ventilation, and listening for gas leakage at the mouth. The breathing circuit was connected to the airway channel and airway patency confirmed with manual test ventilation at 20 cm H20 (water) pressure for 3 s. Data was collected in relation to the time for placement, intraoperative performance and postoperative performance of the airway device. Additionally, investigators rated the ease of insertion and adequacy of lung ventilation on a 5-point scale. The median (interquartile range [range]) time taken to insertion of the device was 31 (26-40[14-780]) s with the ability to ventilate after device insertion 100 (95% CI 96.7- 100)%. Secondary endpoints included one or more manoeuvres 60.3 (95% CI 50.6-69.5)% cases requiring to assist insertion; a median ease of insertion score of 4 (2-5[3-5]), and a median adequacy of ventilation score of 5 (5-5[4-5]). However, the first time insertion rate failure was 9.9% (95% CI 5.1-17.0%). There were no episodes of patient harm recorded, particularly desaturation. The LMA Protector appears suitable for clinical use, but an accompanying article discusses our reflections on the ADEPT approach to studying airway devices from a strategic perspective.

Preventing unrecognised oesophageal intubation: a consensus guideline from the Project for Universal Management of Airways and international airway societies.

Across multiple disciplines undertaking airway management globally, preventable episodes of unrecognised oesophageal intubation result in profound hypoxaemia, brain injury and death. These events occur in the hands of both inexperienced and experienced practitioners. Current evidence shows that unrecognised oesophageal intubation occurs sufficiently frequently to be a major concern and to merit a co-ordinated approach to address it. Harm from unrecognised oesophageal intubation is avoidable through reducing the rate of oesophageal intubation, combined with prompt detection and immediate action when it occurs. The detection of 'sustained exhaled carbon dioxide' using waveform capnography is the mainstay for excluding oesophageal placement of an intended tracheal tube. Tube removal should be the default response when sustained exhaled carbon dioxide cannot be detected. If default tube removal is considered dangerous, urgent exclusion of oesophageal intubation using valid alternative techniques is indicated, in parallel with evaluation of other causes of inability to detect carbon dioxide. The tube should be removed if timely restoration of sustained exhaled carbon dioxide cannot be achieved. In addition to technical interventions, strategies are required to address cognitive biases and the deterioration of individual and team performance in stressful situations, to which all practitioners are vulnerable. These guidelines provide recommendations for preventing unrecognised oesophageal intubation that are relevant to all airway practitioners independent of geography, clinical location, discipline or patient type.

Difficult Airway Society guidelines for awake tracheal intubation (ATI) in adults.

Awake tracheal intubation has a high success rate and a favourable safety profile but is underused in cases of anticipated difficult airway management. These guidelines are a comprehensive document to support decision making, preparation and practical performance of awake tracheal intubation. We performed a systematic review of the literature seeking all of the available evidence for each element of awake tracheal intubation in order to make recommendations. In the absence of high-quality evidence, expert consensus and a Delphi study were used to formulate recommendations. We highlight key areas of awake tracheal intubation in which specific recommendations were made, which included: indications; procedural setup; checklists; oxygenation; airway topicalisation; sedation; verification of tracheal tube position; complications; management of unsuccessful awake tracheal intubation; post-tracheal intubation management; consent; and training. We recognise that there are a range of techniques and regimens that may be effective and one such example technique is included. Breaking down the key practical elements of awake tracheal intubation into sedation, topicalisation, oxygenation and performance might help practitioners to plan, perform and address complications. These guidelines aim to support clinical practice and help lower the threshold for performing awake tracheal intubation when indicated.

Project for Universal Management of Airways - part 1: concept and methods.

Multiple professional groups and societies worldwide have produced airway management guidelines. These are typically targeted at the process of tracheal intubation by a particular provider group in a restricted category of patients and reflect practice preferences in a particular geographical region. The existence of multiple distinct guidelines for some (but not other) closely related circumstances, increases complexity and may obscure the underlying principles that are common to all of them. This has the potential to increase cognitive load; promote the grouping of ideas in silos; impair teamwork; and ultimately compromise patient care. Development of a single set of airway management guidelines that can be applied across and beyond these domains may improve implementation; promote standardisation; and facilitate collaboration between airway practitioners from diverse backgrounds. A global multidisciplinary group of both airway operators and assistants was assembled. Over a 3-year period, a review of the existing airway guidelines and multiple reviews of the primary literature were combined with a structured process for determining expert consensus. Any discrepancies between these were analysed and reconciled. Where evidence in the literature was lacking, recommendations were made by expert consensus. Using the above process, a set of evidence-based airway management guidelines was developed in consultation with airway practitioners from a broad spectrum of disciplines and geographical locations. While consistent with the recommendations of the existing English language guidelines, these universal guidelines also incorporate the most recent concepts in airway management as well as statements on areas not widely addressed by the existing guidelines. The recommendations will be published in four parts that respectively address: airway evaluation; airway strategy; airway rescue and communication of airway outcomes. Together, these universal guidelines will provide a single, comprehensive approach to airway management that can be consistently applied by airway practitioners globally, independent of their clinical background or the circumstances in which airway management occurs.

Global Capnography Project (GCAP): implementation of capnography in Malawi - an international anaesthesia quality improvement project.

The Lancet Commission on Global Surgery emphasised the importance of access to safe anaesthesia care. Capnography is an essential monitor for safe anaesthesia, but is rarely available in low-income countries. The aim of this study was twofold: to measure the prevalence of capnography in the operating theatres and in intensive care units; and to determine whether its introduction was feasible and could improve the early recognition of critical airway incidents in a low-income country. This is the first project to do this. Forty capnographs were donated to eight hospitals in Malawi. Thirty-two anaesthesia providers received a 1-day capnography training course with pre- and post-course knowledge testing. Providers kept logbooks of capnography use and recorded their responses to abnormal readings. On follow-up at 6 months, providers completed questionnaires on any significant patient safety incidents identified using capnography. In January 2017, at the commencement of the project, only one operating theatre had a capnograph. Overall, 97% and 100% 'capnography gaps' were identified in the theatres and intensive care units, respectively. The mean (SD) scores of our capnography multiple choice questionnaires improved after training from 15.00 (3.16) to 18.70 (0.99), p = < 0.001. The capnography equipment was appropriately robust and performed well. Six months following implementation, 24 (77%) anaesthesia providers reported recognising 44 oesophageal intubations and 28 (90%) believed that capnography had saved lives. This study has shown it is feasible to introduce capnography in a low-income country, resulting in early recognition of critical airway incidents and ultimately helping to save lives. Building on the experience of the first trial of pulse oximetry implementation in low-income countries in 2007, we believe this is one of the most important projects in anaesthesia safety in the last decade.

The Airway App: exploring the role of smartphone technology to capture emergency front-of-neck airway experiences internationally.

In this exploratory study we describe the utility of smartphone technology for anonymous retrospective observational data collection of emergency front-of-neck airway management. The medical community continues to debate the optimal technique for emergency front-of-neck airway management. Although individual clinicians infrequently perform this procedure, hundreds are performed annually worldwide. Ubiquitous smartphone technology and internet connectivity have created the opportunity to collect these data. We created the 'Airway App', a smartphone application to capture the experiences of healthcare providers involved in emergency front-of-neck airway procedures. In the first 18-month period, 104 emergency front-of-neck airway management reports were received; 99 (95%) were internally valid and unique from 21 countries. Eighty-one (82%) were performed by non-surgeons and 63 (64%) were 'cannot intubate, cannot oxygenate' emergencies. Overall first-attempt success varied by technique; 45 scalpel-bougie cricothyroidotomy (37 first-attempt success), 25 surgical cricothyroidotomy (15 first-attempt success), eight cannula cricothyroidotomy (five first-attempt success), six wire-guided cricothyroidotomy (three first-attempt success) and 15 tracheostomy reports (11 first-attempt success). The most commonly reported positive human factors were good communication, good teamwork and/or skilled personnel. The most commonly reported negative human factors were fixation on multiple tracheal intubation attempts, delay in initiating emergency front-of-neck airway and/or the failure to plan for failure. Due to the anonymous nature of reporting, reports are open to recollection bias and spurious reporting. We conclude collection of data using a smartphone application is feasible and has the potential to expand our knowledge of emergency front-of-neck airway management.

Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults.

These guidelines provide a strategy to manage unanticipated difficulty with tracheal intubation. They are founded on published evidence. Where evidence is lacking, they have been directed by feedback from members of the Difficult Airway Society and based on expert opinion. These guidelines have been informed by advances in the understanding of crisis management; they emphasize the recognition and declaration of difficulty during airway management. A simplified, single algorithm now covers unanticipated difficulties in both routine intubation and rapid sequence induction. Planning for failed intubation should form part of the pre-induction briefing, particularly for urgent surgery. Emphasis is placed on assessment, preparation, positioning, preoxygenation, maintenance of oxygenation, and minimizing trauma from airway interventions. It is recommended that the number of airway interventions are limited, and blind techniques using a bougie or through supraglottic airway devices have been superseded by video- or fibre-optically guided intubation. If tracheal intubation fails, supraglottic airway devices are recommended to provide a route for oxygenation while reviewing how to proceed. Second-generation devices have advantages and are recommended. When both tracheal intubation and supraglottic airway device insertion have failed, waking the patient is the default option. If at this stage, face-mask oxygenation is impossible in the presence of muscle relaxation, cricothyroidotomy should follow immediately. Scalpel cricothyroidotomy is recommended as the preferred rescue technique and should be practised by all anaesthetists. The plans outlined are designed to be simple and easy to follow. They should be regularly rehearsed and made familiar to the whole theatre team.

5th National Audit Project (NAP5) on accidental awareness during general anaesthesia: protocol, methods, and analysis of data.

BACKGROUND: Accidental awareness during general anaesthesia (AAGA) with recall is a potentially distressing complication of general anaesthesia that can lead to psychological harm. The 5th National Audit Project (NAP5) was designed to investigate the reported incidence, predisposing factors, causality, and impact of accidental awareness. METHODS: A nationwide network of local co-ordinators across all the UK and Irish public hospitals reported all new patient reports of accidental awareness to a central database, using a system of monthly anonymized reporting over a calendar year. The database collected the details of the reported event, anaesthetic and surgical technique, and any sequelae. These reports were categorized into main types by a multidisciplinary panel, using a formalized process of analysis. RESULTS: The main categories of accidental awareness were: certain or probable; possible; during sedation; on or from the intensive care unit; could not be determined; unlikely; drug errors; and statement only. The degree of evidence to support the categorization was also defined for each report. Patient experience and sequelae were categorized using current tools or modifications of such. CONCLUSIONS: The NAP5 methodology may be used to assess new reports of AAGA in a standardized manner, especially for the development of an ongoing database of case reporting. This paper is a shortened version describing the protocols, methods, and data analysis from NAP5--the full report can be found at http://www.nationalauditprojects.org.uk/NAP5_home.

5th National Audit Project (NAP5) on accidental awareness during general anaesthesia: patient experiences, human factors, sedation, consent, and medicolegal issues.

The 5th National Audit Project (NAP5) of the Royal College of Anaesthetists and the Association of Anaesthetists of Great Britain and Ireland into accidental awareness during general anaesthesia (AAGA) yielded data related to psychological aspects from the patient, and the anaesthetist, perspectives; patients' experiences ranged from isolated auditory or tactile sensations to complete awareness. A striking finding was that 75% of experiences were for <5 min, yet 51% of patients [95% confidence interval (CI) 43-60%] experienced distress and 41% (95% CI 33-50%) suffered longer term adverse effect. Distress and longer term harm occurred across the full range of experiences but were particularly likely when the patient experienced paralysis (with or without pain). The patient's interpretation of what is happening at the time of the awareness seemed central to later impact; explanation and reassurance during suspected AAGA or at the time of report seemed beneficial. Quality of care before the event was judged good in 26%, poor in 39%, and mixed in 31%. Three-quarters of cases of AAGA (75%) were judged preventable. In 12%, AAGA care was judged good and the episode not preventable. The contributory and human factors in the genesis of the majority of cases of AAGA included medication, patient, and education/training. The findings have implications for national guidance, institutional organization, and individual practice. The incidence of 'accidental awareness' during sedation (~1:15,000) was similar to that during general anaesthesia (~1:19,000). The project raises significant issues about information giving and consent for both sedation and anaesthesia. We propose a novel approach to describing sedation from the patient's perspective which could be used in communication and consent. Eight (6%) of the patients had resorted to legal action (12, 11%, to formal complaint) at the time of reporting. NAP5 methodology provides a standardized template that might usefully inform the investigation of claims or serious incidents related to AAGA.

5th National Audit Project (NAP5) on accidental awareness during general anaesthesia: summary of main findings and risk factors.

We present the main findings of the 5th National Audit Project (NAP5) on accidental awareness during general anaesthesia (AAGA). Incidences were estimated using reports of accidental awareness as the numerator, and a parallel national anaesthetic activity survey to provide denominator data. The incidence of certain/probable and possible accidental awareness cases was ~1:19,600 anaesthetics (95% confidence interval 1:16,700-23,450). However, there was considerable variation across subtypes of techniques or subspecialities. The incidence with neuromuscular block (NMB) was ~1:8200 (1:7030-9700), and without, it was ~1:135,900 (1:78,600-299,000). The cases of AAGA reported to NAP5 were overwhelmingly cases of unintended awareness during NMB. The incidence of accidental awareness during Caesarean section was ~1:670 (1:380-1300). Two-thirds (82, 66%) of cases of accidental awareness experiences arose in the dynamic phases of anaesthesia, namely induction of and emergence from anaesthesia. During induction of anaesthesia, contributory factors included: use of thiopental, rapid sequence induction, obesity, difficult airway management, NMB, and interruptions of anaesthetic delivery during movement from anaesthetic room to theatre. During emergence from anaesthesia, residual paralysis was perceived by patients as accidental awareness, and commonly related to a failure to ensure full return of motor capacity. One-third (43, 33%) of accidental awareness events arose during the maintenance phase of anaesthesia, mostly due to problems at induction or towards the end of anaesthesia. Factors increasing the risk of accidental awareness included: female sex, age (younger adults, but not children), obesity, anaesthetist seniority (junior trainees), previous awareness, out-of-hours operating, emergencies, type of surgery (obstetric, cardiac, thoracic), and use of NMB. The following factors were not risk factors for accidental awareness: ASA physical status, race, and use or omission of nitrous oxide. We recommend that an anaesthetic checklist, to be an integral part of the World Health Organization Safer Surgery checklist, is introduced as an aid to preventing accidental awareness. This paper is a shortened version describing the main findings from NAP5--the full report can be found at http://www.nationalauditprojects.org.uk/NAP5_home.

Who operates when, where and on whom? A survey of anaesthetic-surgical activity in Ireland as denominator of NAP5.

The second phase of the 5th National Audit Project of the Royal College of Anaesthetists and the Association of Anaesthetists of Great Britain and Ireland, concerning accidental awareness during general anaesthesia, consisted of a survey of anaesthetic activity in Ireland. A network of consultant anaesthetists co-ordinated data collection from the anaesthetic departments of 46 public and 20 independent hospitals over seven days. Data on patients' characteristics, anaesthetic techniques, staffing, and admission and discharge arrangements were collected on all cases for which anaesthetic care (general, regional or local anaesthesia, sedation or monitored anaesthesia care) was provided. A total of 8049 cases were reported during the survey, giving an annual estimate of 426 600 cases for which anaesthetic care is provided. General anaesthesia constituted 5621 (70%), regional anaesthesia 1404 (17%), local anaesthesia 290 (4%), sedation 618 (8%) and monitored anaesthesia care 116 (1%) of the total number of cases. This survey provides unique data regarding anaesthesia services in public and independent hospitals in Ireland.

A national survey (NAP5-Ireland baseline) to estimate an annual incidence of accidental awareness during general anaesthesia in Ireland.

As part of the 5th National Audit Project of the Royal College of Anaesthetists and the Association of Anaesthetists of Great Britain and Ireland concerning accidental awareness during general anaesthesia, we issued a questionnaire to every consultant anaesthetist in each of 46 public hospitals in Ireland, represented by 41 local co-ordinators. The survey ascertained the number of new cases of accidental awareness becoming known to them for patients under their care or supervision for a calendar year, as well as their career experience. Consultants from all hospitals responded, with an individual response rate of 87% (299 anaesthetists). There were eight new cases of accidental awareness that became known to consultants in 2011; an estimated incidence of 1:23 366. Two out of the eight cases (25%) occurred at or after induction of anaesthesia, but before surgery; four cases (50%) occurred during surgery; and two cases (25%) occurred after surgery was complete, but before full emergence. Four cases were associated with pain or distress (50%), one after an experience at induction and three after experiences during surgery. There were no formal complaints or legal actions that arose in 2011 related to awareness. Depth of anaesthesia monitoring was reported to be available in 33 (80%) departments, and was used by 184 consultants (62%), 18 (6%) routinely. None of the 46 hospitals had a policy to prevent or manage awareness. Similar to the results of a larger survey in the UK, the disparity between the incidence of awareness as known to anaesthetists and that reported in trials warrants explanation. Compared with UK practice, there appears to be greater use of depth of anaesthesia monitoring in Ireland, although this is still infrequent.

The 5th National Audit Project (NAP5) on accidental awareness during general anaesthesia: protocol, methods and analysis of data.

Accidental awareness during general anaesthesia with recall is a potentially distressing complication of general anaesthesia that can lead to psychological harm. The 5th National Audit Project was designed to investigate the reported incidence, predisposing factors, causality and impact of accidental awareness. A nationwide network of local co-ordinators across all UK and Irish public hospitals reported all new patient reports of accidental awareness to a central database, using a system of monthly anonymised reporting over a calendar year. The database collected the details of the reported event, anaesthetic and surgical technique, and any sequelae. These reports were categorised into main types by a multidisciplinary panel, using a formalised process of analysis. The main categories of accidental awareness were: certain or probable; possible; during sedation; on or from the intensive care unit; could not be determined; unlikely; drug errors; and statement only. The degree of evidence to support the categorisation was also defined for each report. Patient experience and sequelae were categorised using current tools or modifications of such. The 5th National Audit Project methodology may be used to assess new reports of accidental awareness during general anaesthesia in a standardised manner, especially for the development of an ongoing database of case reporting. This paper is a shortened version describing the protocols, methods and data analysis from 5th National Audit Project - the full report can be found at http://www.nationalauditprojects.org.uk/NAP5_home#pt.

The 5th National Audit Project (NAP5) on accidental awareness during general anaesthesia: summary of main findings and risk factors.

We present the main findings of the 5th National Audit Project on accidental awareness during general anaesthesia. Incidences were estimated using reports of accidental awareness as the numerator, and a parallel national anaesthetic activity survey to provide denominator data. The incidence of certain/probable and possible accidental awareness cases was ~1:19 600 anaesthetics (95% CI 1:16 700-23 450). However, there was considerable variation across subtypes of techniques or subspecialties. The incidence with neuromuscular blockade was ~1:8200 (1:7030-9700), and without it was ~1:135 900 (1:78 600-299 000). The cases of accidental awareness during general anaesthesia reported to 5th National Audit Project were overwhelmingly cases of unintended awareness during neuromuscular blockade. The incidence of accidental awareness during caesarean section was ~1:670 (1:380-1300). Two thirds (82, 66%) of cases of accidental awareness experiences arose in the dynamic phases of anaesthesia, namely induction of and emergence from anaesthesia. During induction of anaesthesia, contributory factors included: use of thiopental; rapid sequence induction; obesity; difficult airway management; neuromuscular blockade; and interruptions of anaesthetic delivery during movement from anaesthetic room to theatre. During emergence from anaesthesia, residual paralysis was perceived by patients as accidental awareness, and commonly related to a failure to ensure full return of motor capacity. One third (43, 33%) of accidental awareness events arose during the maintenance phase of anaesthesia, most due to problems at induction or towards the end of anaesthesia. Factors increasing the risk of accidental awareness included: female sex; age (younger adults, but not children); obesity; anaesthetist seniority (junior trainees); previous awareness; out-of-hours operating; emergencies; type of surgery (obstetric, cardiac, thoracic); and use of neuromuscular blockade. The following factors were not risk factors for accidental awareness: ASA physical status; race; and use or omission of nitrous oxide. We recommend that an anaesthetic checklist, to be an integral part of the World Health Organization Safer Surgery checklist, is introduced as an aid to preventing accidental awareness. This paper is a shortened version describing the main findings from 5th National Audit Project - the full report can be found at http://www.nationalauditprojects.org.uk/NAP5_home#pt.

The 5th National Audit Project (NAP5) on accidental awareness during general anaesthesia: patient experiences, human factors, sedation, consent and medicolegal issues.

The 5th National Audit Project of the Royal College of Anaesthetists and the Association of Anaesthetists of Great Britain and Ireland into accidental awareness during general anaesthesia yielded data related to psychological aspects from the patient, and the anaesthetist, perspectives; patients' experiences ranged from isolated auditory or tactile sensations to complete awareness. A striking finding was that 75% of experiences were for < 5 min, yet 51% of patients (95% CI 43-60%) experienced distress and 41% (95% CI 33-50%) suffered longer-term adverse effect. Distress and longer-term harm occurred across the full range of experiences but were particularly likely when the patient experienced paralysis (with or without pain). The patient's interpretation of what is happening at the time of the awareness seemed central to later impact; explanation and reassurance during suspected accidental awareness during general anaesthesia or at the time of report seemed beneficial. Quality of care before the event was judged good in 26%, poor in 39% and mixed in 31%. Three quarters of cases of accidental awareness during general anaesthesia (75%) were judged preventable. In 12% of cases of accidental awareness during general anaesthesia, care was judged good and the episode not preventable. The contributory and human factors in the genesis of the majority of cases of accidental awareness during general anaesthesia included medication, patient and education/training. The findings have implications for national guidance, institutional organisation and individual practice. The incidence of 'accidental awareness' during sedation (~1:15 000) was similar to that during general anaesthesia (~1:19 000). The project raises significant issues about information giving and consent for both sedation and anaesthesia. We propose a novel approach to describing sedation from the patient's perspective which could be used in communication and consent. Eight (6%) of the patients had resorted to legal action (12, 11%, to formal complaint) at the time of reporting. The 5th National Audit Project methodology provides a standardised template that might usefully inform the investigation of claims or serious incidents related to accidental awareness during general anaesthesia.

The Theatre Recovery and Anaesthetic nurse Capnography Education (TRACE) project.

The Theatre Recovery and Anaesthetic Nurse Capnography Education (TRACE) project is a multidisciplinary quality improvement project. The overall aim is to educate anaesthetic and recovery nurses on the correct use of capnography and educate non-consultant hospital doctors on the guidelines on Preventing Unrecognised Oesophageal Intubation from the Project for Universal Management of Airways group. This project addresses technical aspects of task performance such as correct waveform identification and interpretation, troubleshooting abnormal waveforms and establishing routine checks of capnography both pre-induction and post-intubation. The pre-induction verification of the correct function of capnography is an essential component of this project. In addition, the project focuses on team aspects of task performance with an emphasis on team psychological safety, empowering nurses to speak up using graded assertiveness and flattening hierarchies. As a result of the project, our nurses' knowledge about capnography and waveform identification improved to over 80% correct answers six months after completion of the project. In addition, over 90% of participants reported feeling confident in speaking up to both consultants and non-consultant hospital doctors when a waveform was not present before induction of anaesthesia or after attempted tracheal intubation.