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.

Major complications of airway management: a prospective multicentre observational study.

We conducted an observational study of serious airway complications, using similar methods to the fourth UK National Audit Project (NAP4) over a period of 1 year across four hospitals in one region in the UK. We also conducted an activity survey over a week, using NAP4 methods to yield an estimate for relevant denominators to help interpret the primary data. There were 17 serious airway complications, defined as: failed airway management leading to cancellation of surgery (eight); airway management in recovery (five); unplanned intensive care admission (three); and unplanned emergency front of neck access (one). There were no reports of death or brain damage. This was an estimate of 0.028% (1 in 3600) complications using the denominator of 61,000 general anaesthetics per year in the region. Complications in patients with 'predicted easy' airways were rare (approximately 1 in 14,200), but 45 times more common in those with 'predicted difficult' airways (approximately 1 in 315). Airway management in both groups was similar (induction of anaesthesia followed by supraglottic airway or tracheal tube). Use of awake/sedation intubation, videolaryngoscopy and high-flow nasal oxygenation were uncommon even in the predicted difficult airway patients (in 2.7%, 32.4% and 9.5% of patients, respectively). We conclude that the incidence of serious airway complications is at least as high as it was during NAP4. Despite airway prediction being used, this is not informing subsequent management.

A comparison of gastric gas volumes measured by computed tomography after high-flow nasal oxygen therapy or conventional facemask ventilation.

High-flow nasal oxygen therapy is increasingly used to improve peri-intubation oxygenation. However, it is unknown whether it may cause or exacerbate insufflation of gas into the stomach. High-flow nasal oxygen therapy is now standard practice in our hospital for adult patients undergoing percutaneous thermal ablation of liver cancer under general anaesthesia with tracheal intubation. We compared gastric gas volumes measured from computed tomography images that had been acquired immediately after intubation in two series of patients: 50 received peri-intubation high-flow nasal oxygen therapy and another 50 received conventional facemask pre-oxygenation and ventilation before intubation and before high-flow nasal oxygen therapy became standard practice in our unit. Median (IQR [range]) gastric gas volume was 24.0 (14.2-59.9 [3-167]) cm3 in the high-flow nasal oxygen therapy group and 23.8 (12.6-38.8 [0-185]) cm3 in the facemask group. There was no difference between the two groups in the volume of gastric gas measured by computed tomography imaging (Mann-Whitney U-test, U = 1136, p = 0.432, n1  = n2  = 50). Our results demonstrate that a small volume of gastric gas is commonly present after induction of anaesthesia, but that the use of peri-intubation high-flow nasal oxygen therapy for pre-oxygenation and during apnoea does not increase this volume compared with conventional facemask pre-oxygenation and ventilation. This is clinically relevant, as high-flow nasal oxygen therapy is increasingly being used in a peri-intubation context and in patients at higher risk of aspiration.

Anticipated difficult airway during obstetric general anaesthesia: narrative literature review and management recommendations.

We reviewed the literature on management of general and regional anaesthesia in pregnant women with anticipated airway difficulty. We identified 138 publications comprising 158 cases; these either described equipment or techniques for the provision of general anaesthesia, or the management of women with regional analgesia or anaesthesia, with the aim of avoiding general anaesthesia. Most of the former group described women requiring caesarean section alone, or in combination with other surgery, which was sometimes airway-related. Management techniques were largely similar to those in non-obstetric patients requiring surgery who have airway difficulties, although suggested differences related to physiological changes of pregnancy and avoidance of nasal intubation. In the reports discussing regional anaesthesia, consideration was often given to the possible requirement for urgent out-of-hours anaesthetic intervention, and the predicted difficulty of management of general anaesthesia should it be required. In a number of reported cases, multidisciplinary planning led to the conclusion that elective caesarean section should be performed in order to avoid emergency airway management. Based on this literature review, we advise antenatal planning that includes: assessment of the patient's clinical characteristics; consideration of the equipment and personnel available to provide safe airway management out-of-hours; and elective caesarean section should these be lacking. If general anaesthesia is required, a risk assessment must be made as to the probability of safe airway management after the induction of anaesthesia, and awake tracheal intubation should be used if this cannot be assured. Decision aids are provided to illustrate these points. Online appendices include a comprehensive compendium of case reports on the management of a number of rare syndromes and airway conditions.

Fibreoptic-guided tracheal intubation through i-gel® and LMA® ProtectorTM supraglottic airway devices - a randomised comparison.

Fibreoptic-guided tracheal intubation using a supraglottic airway device as a conduit is a technique that can be used in anticipated and unanticipated difficult airway management. Although the i-gel® supraglottic airway device has been examined for this purpose, the LMA® ProtectorTM , a recently introduced second-generation supraglottic airway device, has not been evaluated for this use in clinical trials. This prospective, randomised clinical trial compared fibreoptic-guided tracheal intubation via i-gel and LMA Protector supraglottic airway devices in two UK hospitals. Patients who were ASA physical status 1 or 2 and undergoing elective surgery requiring tracheal intubation were recruited to the study. A block randomisation list was generated for each study site. The primary outcome measure was time to successful tracheal intubation and secondary outcomes were tracheal intubation success rate, glottic view through flexible fibrescope, ease of tracheal intubation using operator visual analogue score, supraglottic airway device insertion time and insertion success rate. Ninety patients were randomly allocated to each device, and final data analysis was carried out for 92 patients in the i-gel group and 86 patients in the LMA Protector group. Mean (SD) tracheal intubation time in the i-gel and LMA Protector groups were 54.3 (13.8) s and 52.0 (13.0) s, respectively (p = 0.240). There were no significant differences in tracheal intubation success rate, glottic view and ease of tracheal intubation between the two groups. This study demonstrates that the LMA Protector supraglottic airway device is comparable to the i-gel supraglottic airway device as a conduit for fibreoptic-guided tracheal intubation.

Systematic review of benefits or harms of routine anaesthetist-inserted throat packs in adults: practice recommendations for inserting and counting throat packs: An evidence-based consensus statement by the Difficult Airway Society (DAS), the British Association of Oral and Maxillofacial Surgery (BAOMS) and the British Association of Otorhinolaryngology, Head and Neck Surgery (ENT-UK).

Throat packs are commonly inserted by anaesthetists after induction of anaesthesia for dental, maxillofacial, nasal or upper airway surgery. However, the evidence supporting this practice as routine is unclear, especially in the light of accidentally retained throat packs which constitute 'Never Events' as defined by NHS England. On behalf of three relevant national organisations, we therefore conducted a systematic review and literature search to assess the evidence base for benefit, and also the extent and severity of complications associated with throat pack use. Other than descriptions of how to insert throat packs in many standard texts, we could find no study that sought to assess the benefit of their insertion by anaesthetists. Instead, there were many reports of minor and major complications (the latter including serious postoperative airway obstruction and at least one death), and many descriptions of how to avoid complications. As a result of these findings, the three national organisations no longer recommend the routine insertion of throat packs by anaesthetists but advise caution and careful consideration. Two protocols for pack insertion are presented, should their use be judged necessary.

The development of a VBHOM-based outcome model for lower limb amputation performed for critical ischaemia.

BACKGROUND: VBHOM (Vascular Biochemistry and Haematology Outcome Models) adopts the approach of using a minimum data set to model outcome and has been previously shown to be feasible after index arterial operations. This study attempts to model mortality following lower limb amputation for critical limb ischaemia using the VBHOM concept. METHODS: A binary logistic regression model of risk of mortality was built using National Vascular Database items that contained the complete data required by the model from 269 admissions for lower limb amputation. The subset of NVD data items used were urea, creatinine, sodium, potassium, haemoglobin, white cell count, age on and mode of admission. This model was applied prospectively to a test set of data (n=269), which were not part of the original training set to develop the predictor equation. RESULTS: Outcome following lower limb amputation could be described accurately using the same model. The overall mean predicted risk of mortality was 32%, predicting 86 deaths. Actual number of deaths was 86 (chi(2)=8.05, 8 d.f., p=0.429; no evidence of lack of fit). The model demonstrated adequate discrimination (c-index=0.704). CONCLUSIONS: VBHOM provides a single unified model that allows good prediction of surgical mortality in this high risk group of individuals. It uses a small, simple and objective clinical data set that may also simplify comparative audit within vascular surgery.