Airways-2

CPR2As we wait for the new 2015 guidelines for resuscitation later this year, the protocol for a major study which should be completed in time for inclusion in the evidence review for the 2020 guidelines is now available on-line.

‘Project portfolio HTA 12/167/102, Cluster randomised trial of the clinical and cost effectiveness of the i-gel supraglottic airway device versus tracheal intubation in the initial airway management of out of hospital cardiac arrest (Airways-2)’

Just over a year ago I uploaded a blog post entitled, REVIVE airway study – clinical outcomes and future plans. As well as reviewing REVIVE 1, the article discussed the future plans for REVIVE 2, now called AIRWAYS-2. Publication is expected in 2019, which if realised, will allow the study to be considered as part of the 2020 ILCOR Scientific Evidence Evaluation and Review System (SEERS) process.

Why is this trial important? Well, AIRWAYS-2 is an attempt to provide the type of high quality evidence called for back in 2009 by Nolan and Lockey in an editorial entitled, ‘Airway management for OHCA – more data required’. In this editorial, the authors commented that, ‘Virtually all the existing data relating to the use of SADs in cardiac arrest are derived from low-level studies. There is an urgent need for high-quality randomised controlled trials of the use of SADs for CPR.’ However, such studies are not easy to perform in the pre-hospital setting.

The AIRWAYS-2 trial summary confirms that:

 ‘There is real uncertainty amongst paramedics and experts in the field about the best method to ensure a clear airway during the early stages of OHCA. We therefore propose to undertake a large research study to determine whether intubation or the best available SAD (called the i‐gel) gives the best chance of recovery following OHCA.’

Paramedics from the following four English NHS ambulance services will participate:

  • South Western Ambulance Service NHS Foundation Trust (SWAST)
  • East of England Ambulance Service NHS Trust
  • East Midlands Ambulance Service NHS Trust
  • Yorkshire Ambulance Service NHS Trust

 As randomisation by patient is impractical in the pre-hospital emergency setting, randomisation will be by paramedic. The trial population will include adults who have suffered an OHCA that is not due to trauma. Patient exclusion criteria includes an estimated weight <50kg and a mouth opening of <2cm.

The trial intervention control group is the current standard care pathway: Tracheal intubation. The Intervention group (i-gel) is referred to as follows:

 ‘Because of its speed and ease of insertion, and the fact that it does not require a cuff to be inflated, the i‐gel has emerged as the preferred SAD for use during OHCA in Europe.’

 The aim and objectives of the study are confirmed as follows:

 Aim:

  • To determine whether the i‐gel, a second‐generation SAD, is superior to tracheal intubation in non-traumatic OHCA in adults, in terms of both clinical and cost effectiveness.

 Objectives:

  1. To estimate the difference in the primary outcome of modified Rankin Scale (mRS) at hospital discharge between groups of patients managed by paramedics randomised to use either the i‐gel or intubation as their initial airway management strategy following OHCA.
  2. To estimate differences in secondary outcome measures relating to airway management, hospital stay and recovery at 3 and 6 months (see section 4.6.2) between groups of patients managed by paramedics randomised to use either the i‐gel or intubation.
  3. To estimate the comparative cost effectiveness of the i‐gel and intubation, including estimating major in hospital resources and subsequent costs (length of stay, days of intensive and high dependency care, etc.) in each group.

The secondary outcomes include initial ventilation success, regurgitation/aspiration, the sequence of airway ventilations delivered and return of spontaneous circulation (ROSC). Additional secondary outcomes will be recorded for patients who survive to hospital and to hospital discharge, including for the latter, Modified Rankin scale and quality of life at 3 and 6 months following OHCA.

It is stated that a 2% improvement in the proportion of patients achieving a good clinical outcome would be clinically significant. This study will also include an economic evaluation. It is estmated that 1,300 paramedics will participate and the cost will be over £2 million.

An Airways-2 web-site is now up and running, and includes an overview of the trial, details regarding the study team and an FAQ page.

Four years may seem a long time to wait and there is always the risk that by the time the results are ready to be published, the landscape of airway management during cardiac arrest has changed. However, it would be difficult to factor out such a risk, and AIRWAYS-2 can be seen as a significant attempt to provide the high level data regarding management of the airway during the initial stages of cardiac arrest we all want to see.

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Paediatric i-gel® – a review of the latest evidence

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In a blog post written in December 2012, the question was asked as to whether paediatric i-gel® was an advance over other supraglottic airways? The article reviewed the evidence already published and concluded that:

‘Clinical evidence takes time to build, and some of the studies looked at one size only and all studies have limitations. However, the above evidence suggests i-gel may yet prove to be “a genuine improvement on the pLMA”, as thought possible by White, Cook and Stoddart back in 2009.’

This was a reference to a comment in the excellent review article ‘A critique of elective pediatric supraglottic airway devices’ pubished in Pediatric Anesthesia by White et al, which aimed to present the evidence surrounding the use of currently available supraglottic airways (SADs) in routine paediatric anaesthetic practice. It was also one of the first papers to divide SADs in to first and second generation devices, although the first paper to describe the classification fully was ‘Recent developments in efficacy and safety of supraglottic airway devices’ by Cook and Howes. In the White et al review, first generation devices were described as simple airway tubes, and second generation devices, such as i-gel®, as incorporating ‘specific design features to improve safety by protecting against regurgitation and aspiration’.

The White et al review concluded that ‘The pLMA has yet to be outperformed by any other SAD, making it the premier SAD in children and the benchmark by which newer second generation devices should now be compared’.

Five years on and almost 2 years since my earlier blog post, what additional evidence has been published for the paediatric sizes of Intersurgical i-gel® and does this new data help us to draw a more definitive conclusion to the question I asked back in 2012?

The new data includes two meta-analyses and a number of comparative studies. There are also some interesting letters, review articles and one survey of current UK practice for paediatric SADs. The data ranges from an assessment of the effect of the device on intraocular pressure in paediatric patients who received sevoflurane or desflurane during strabismus surgery to fibreoptic assessment of laryngeal positioning to a clinical evaluation of airway management with the device during MRI examination.

The two meta-analyses were both published in 2014. The first, ‘A systematic review and meta-analysis of the i-gel vs laryngeal mask airway in children’ by Choi et al included nine Randomised Controlled Trials (RCTs) comparing i-gel to different types of laryngeal mask in children. The different types of laryngeal masks were the LMA ProSeal® (pLMA), the LMA Classic® (cLMA), the LMA Supreme® (sLMA) and the Ambu® AuraOnce™ (ALMA).

All four of these devices are quite different in design, and although there is a subgroup analysis for the different types of device, the overall conclusions are a comment on i-gel® in comparison to all the laryngeal masks as a collective group. The conclusions were that, ‘i-gel was similar to LMAs when used in children and delivered ventilation pressures 3cm H20 higher than LMAs. Few complications were reported with either airway.’

The other meta-analysis, ‘Evaluation of i-gel airway in children: a meta analysis’, by Maitra et al and published in Pediatric Anesthesia, included nine RCTs where i-gel® had been compared to the cLMA and/or the pLMA . The authors concluded that ‘The i-gel® airway is at least equally effective with laryngeal mask airway ProSeal and laryngeal mask airway Classic and provides a significantly higher oropharyngeal leak pressure than both the laryngeal masks.’ The authors of both meta-analyses acknowledge a number of limitations to their papers. An important consideration is certainly whether any statistically significant differences identified between devices are also clinically significant. i-gel

A particularly interesting article, published in 2013, is ‘Current practice of pediatric supraglottic airway devices – a survey of members of the Association of Paediatric Anaesthetists of Great Britain and Ireland (APAGBI)’. It assessed usage of SADs in routine and difficult airways in the UK by distributing a survey with sixteen questions to all UK members of the APAGBI. Two hundred and fourty-four members replied.

88% ‘favoured’ first generation SADs for routine use and 85% ‘preferentially’ for use in the failed intubation scenario. As the pLMA, a second generation device, is often considered the premier SAD for use in children, this is perhaps a little surprising. In fact, only 1% of responders confirmed the pLMA as their first choice/usual SAD. 49% would never use a SAD on a patient weighing less than 5kg. Only 15% ‘felt that an esophageal drainage tube was an important feature.’

The authors confirm that, ‘Fibreoptic guided intubation via an SAD is used electively by 46% of respondents, and only 3% regularly employ this technique. 17% have used the technique in an emergency, 20% have only practiced it on a manikin, and 9% have never used or seen this technique in any situation.’

With regard to i-gel, 37% of respondents reported they had access to the device. This compared to 25% with access to the pLMA and 14% to the sLMA. However, only 1% confirmed i-gel® as their first choice/usual SAD. The same percentage as reported for the pLMA. 87% had access to a classically shaped laryngeal mask airway, with 77% using it as their first-choice/usual SAD. Only 15% considered an esophageal drain channel as an important design feature.

So why the low use and apparent limited interest in second generation SADs, such as i-gel® and the pLMA amongst members of the APAGBI? The authors suggest there may be a number of reasons for the slower adoption than with the adult sizes, such as paediatric sizes coming onto the market later than adult sizes, the bulkier design of paediatric sizes and because aspiration associated with SAD use is seen less frequently and has less morbidity in children when compared with adults. It maybe the potential safety features are therefore considered by paediatric anaesthetists to be less essential.

The authors conclude that, ‘Research currently has little influence over the choice of which SAD to use, which is more likely determined by personal choice and departmental preference.’

Whilst writing this review, two additional papers of interest were published in Anaesthesia. The first, ‘A performance comparison of the paediatric i-gel with other supraglottic airway devices’ by Smith & Bailey includes data from fourteen RCTs and eight observational studies. The authors conclude that, ‘the i-gel is at least equivalent to other supraglottic airway devices curently available for use in children, and may enable a higher oropharyngeal leak pressure and an improved fibreoptic view of the glottis.’

The other paper is a particularly interesting editorial, entitled, ‘Which supraglottic airway will serve my patient best?, also published in Anaesthesia. Whilst not specifically focussed on paediatric SADs, the paper mentions two of the meta-analyses discussed in this blog post.

The authors Kristensen, Teoh and Asai consider how the ‘right’ device should be chosen, when a new device can be introduced into clinical practice, the role of manikin studies and manufacturer’s responsibilities. They also discuss the ADEPT guidance formulated by the Difficult Airway Society (DAS).

The authors comment that, ‘Until significantly better features of a new airway device relating to clinically important outcome measures have been shown, we should be cautious about replacing the conventional device with a new one…We can judge whether or not a new device has a clinically meaningful difference (superiority) to the conventional device, mainly by assessing the results of randomised controlled studies and meta-analyses. Nevertheless, if randomised controlled studies only show statistically significant differences that are not clinically meaningful, the reports of meta-analyses will not provide clinically meaningful information for our decision making.’

So what conclusions can we draw from the new data published for i-gel? Is the device superior to other paediatric supraglottic airways already available? Well, the new data is varied in subject matter, includes a number of RCTs, comparative studies and meta-analyses. Most of the data is encouraging and some possible advantages have been identified. However, there are always areas where more data is required or desirable. I will leave you to review the evidence for yourself and draw your own conclusions.

Note:
i-gel is a registered trademark of Intersurgical Ltd. LMA Classic, LMA ProSeal, LMA Unique and LMA Supreme are registered trade marks of the Laryngeal Mask Company Ltd. cLMA, pLMA, and sLMA are abbreviations used in some journal articles. They refer to the LMA Classic, LMA Proseal and LMA Supreme respectively. Ambu is a registered trademark of Ambu A/S.

Pre-hospital airway management – the debate continues

 In a recent editorial published in Resuscitation, entitled ‘Pre-hospital airway management: The data grows rapidly but controversy remains’, David Lockey and Hans Morten Lossius discuss the results from three studies published in the same issue:

1. An update of out of hospital airway management practices in the United States.

2. Higher insertion success with the i-gel supraglottic airway in out-of-hospital cardiac arrest: A randomised controlled trial.

3. The impact of airway management on quality of cardiopulmonary resuscitation: an observational study in patients during cardiac arrest.

An update of out of hospital airway management practices in the United States

Digges et al utilised the 2012 National Emergency Medical Services Information System (NEMSIS) Public-Release Research Data Set to examine over 19 million EMS activations. This included 74,993 intubations, 21,990 alternate airway patient care events (confirmed as either a Combitube®, Esophageal Obturator, Laryngeal Mask Airway or King LT®) and 1,332 Cricothyroidotomys. BVM ventilation was undertaken on 56,025 occassions and there were 54,241 oropharyngeal airway (OPA) and 404,828 nasopharyngeal airway (NPA) interventions.

Overall intubation success was 85.3%. Alternate airway success rates were 79.6% overall. The most successful of these was was the King LT® (89.7%) and the least successful the Esophageal Obturator (38.0%).

It is interesting to make some comparison of these results to an earlier examination of the same database for EMS activations four years earlier in 2008. The earlier study included fewer states, so any comparison must be undertaken with caution, but the alternate airway devices recorded as having been used were the same in both reports.

This is worth noting, as the alternate airway devices used are quite different from those used in some other markets such as the UK. As reported in a previous blog post, in the Adult ALS chapter of the Resuscitation Council (UK) 2010 Resuscitation Guidelines, it is confirmed that ‘The Combitube® is rarely, if ever, used in the UK and is no longer included in these guidelines’, and in addition that the Laryngeal Tube (LT) ‘is not in common use in the UK’. What about the rest of Europe? In the 2010 European Resuscitation Council (ERC) Guidelines for Resuscitation, it is stated that ‘Use of the Combitube® is waning and in many parts of the world is being replaced by other devices such as the LT’. In the two papers utilising the NEMSIS data discussed in this blog post, there is no mention of the newer 2nd generation SADs such as the i-gel® and LMA Supreme® which are in regular use in many countries.

In an editorial published in 2009 in Resuscitation, the official journal of the European Resuscitation Council, entitled, ‘Airway management for out-of-hospital cardiac arrest – More data required’, Nolan and Lockey concluded that ‘New airway devices appear frequently but, in our opinion, the three currently available disposable SADs that need to be studied for use during CPR are the i-gel®, the LMA Supreme® and the disposable LT’. Only one of these devices, the LT, was used in the Diggs update of out-of-hospital airway management practices in the United States.

This is significant, as the authors of the update of out of hospital airway management practices in the U.S. state that, ‘This study and many others show that there are problems with out-of-hospital ETI. The results of this study show that alternate airways are not the answer’. As Lockey and Lossius comment, the latter point is a ‘strong and controversial statement’. The latter also make a number of additional important points, including confirmation that ‘although supraglottic devices are clearly not all equal, the highest performing devices have similar success to intubation without the high training burden and risks of oesophageal intubation’.

This leads in nicely to the second study discussed in their editorial:

Higher insertion success with the i-gel® supraglottic airway in out-of-hospital cardiac arrest: A randomised controlled trial.

 Lockey and Lossius introduce the study as follows:

‘Confirming the major difference between the performance of different supraglottic devices, and also published in this issue, is a pre-hospital randomised trial of the second generation i-gel™ device vs an LMA™. Significantly different success rates were demonstrated and the second generation device clearly outperformed the LMA™.’ The laryngeal mask compared to i-gel® in this study was the Portex® Soft Seal® device.

A first generation SAD has been described as a ‘simple airway tube’ and a second generation SAD as ‘incorporating specific design features to improve safety by protecting against regurgitation and aspiration’ (White, Cook and Stoddart)

The paper Lockey and Lossius refer to is a single centre, prospective parallel-group ‘open label’ randomised controlled trial (RCT) in which patients in cardiac arrest were allocated to either the Intersurgical i-gel® supraglottic airway or the Portex® Soft Seal® Laryngeal Mask. The primary outcome was successful insertion as determined by the paramedic who inserted the device.

Fifty-one patients were randomised. Three were not in cardiac arrest, so the final analysis reports on data from forty-eight patients. The Intersurgical i-gel® had an insertion success rate of 90% (18/20) compared to 57% (16/28) with the Portex® Soft Seal® (p=0.023). The authors concluded that:

‘The i-gel® supraglottic airway was associated with higher successful insertion rates in subjects with out-of-hospital cardiac arrest. The i-gel® supraglottic appears easier for paramedics to use and appears a suitable first line supraglottic airway for out-of-hospital cardiac arrest’.

As confirmed earlier, there was no data for i-gel® or a number of the other newer 2nd generation supraglotic airways in ‘An update of out of hospital airway management practices in the United States’ by Diggs et al. Evidence for one supraglottic airway should not be extrapolated to another device with different design characteristics, so their data is only relevant to those devices included.

The impact of airway management on quality of cardiopulmonary resuscitation: an observational study in patients during cardiac arrest

The third paper discussed by Lockey and Lossius is, ‘ The impact of airway management on quality of cardiopulmonary resuscitation: an observational study in patients during cardiac arrest’. This prospective observational study by Yeung et al enrolled 100 consecutive patients between 2008 and 2011 with the aim of determining the effect of advanced airway use, either an endotracheal tube (ET) or laryngeal mask airway (LMA) on the no flow ratio (NFR) and other measures of CPR quality. The control cohort was patients receiving only bag-mask ventilation. The results showed use of an advanced airway during in-hospital cardiac arrest was associated with improved no flow ratios. The primary reason for the improvement appears to be switching from a compression to ventilation ratio of 30:2 to continuous chest compressions and asynchronous ventilation. Further details can be accessed with the earlier link.

A particularly interesting aspect of this paper is the discussion section, where the uncertainties about the role of advanced airways in cardiac arrest are examined. Firstly there is uncertainty about whether ventilation is required at all in the early stages of cardiac arrest (the Yeung et al paper examined patients in the later stage of out-of-hospital or in-hospital cardiac arrest where some form of ventilation is required). They mention the studies from Arizona prioritising Cardio-Cerebral Resuscitation (CCR) over ventilation in the early stages of cardiac arrest.

The timing of airway intervention and any impact on interruptions in chest compressions are also likely to be important. There is discussion regarding interruptions in CPR and the link to reductions in coronary perfusion pressure and development of ventricular fibrillation (VF). The potential impact of supraglottic airways on carotid blood flow, dislodgement of LMAs and aspiration risk are also discussed. All important subjects.

In their editorial, Lockey and Lossius comment that, ‘This study is one of several that demonstrate potential improvements in quality indicators in resuscitation which may be in conflict with large studies with undifferentiated casemix and resuscitation techniques which generally question the value of advanced life support techniques in cardiac arrest or trauma patients.’

Conclusion

So where does all this new data leave us? Lockey and Lossius conclude that ‘Our interpretation of the currently available data on pre-hospital advanced airway management is that the risks and benefits need to be considered for every patient on scene with airway compromise. The management that results from this analysis will depend on the indications and condition of the patient as well as the skills and available interventions on scene.’ This is not entirely dissimilar to the statement in the European Resuscitation Council (ERC) guidelines for resuscitation 2010 in relation to airway management during cardiac arrest, which state that ‘There are no data supporting the routine use of any specific approach to airway management during cardiac arrest. The best technique is dependent on the precise circumstances of the cardiac arrest and the competence of the rescuer.’

With regard to SADs, Lockey and Lossius conclude:

‘The constant evolution of existing supraglottic airways and the introduction of new devices makes generalisation and performance assessment of these devices difficult, but the expanding dataset will hopefully ensure that only the highly performing devices will be used in future studies, thus making interpretation more straightforward’.

No doubt REVIVE#2 will provide some useful additional data in this regard and it is to be hoped that additional randomised controlled trials, similar to the study published by Middleton et al discussed here, will be conducted so the dataset continues to expand.

REVIVE airway study – clinical outcomes and future plans

Since plans were first announced to conduct a randomised comparison of two second generation SADs to current practice in the initial airway management of out-of-hospital cardiac arrest (OHCA) in a UK ambulance service, the results have been eagerly anticipated. This can be no surprise given the paucity of high level evidence to confirm the best technique for maintaining an airway and providing ventilation in adults with cardiopulmonary arrest.

However, the primary objective of REVIVE was not to provide a definitive answer to the above question, but to assess the feasibility of the study design. If REVIVE proved the design was feasible, capable of establishing whether ventilation success can be achieved, and of measuring other key outcomes such as return of spontaneous ventilation and survival to hospital, then it would lay the foundation for a future full-scale study which might just provide us with the answer to the above question.

The REVIVE airway working group presented a poster at the International Conference on Emergency Medicine (ICEM) in Dublin in June last year entitled, ‘Early report of paramedic recruitment in the REVIVE-Airways study’. This confirmed the target of recruiting 150 randomised paramedics and stratification by experience and base station location had been successfully achieved.

Last month, in an abstract presented at the American Heart Association Resuscitation Science Symposium in Dallas, we had our first glimpse of the data related to the clinical outcomes. As this was a feasibility trial and not designed or powered to show clinically significant differences between each device or study arm, there was some discussion as to whether the clinical data should be released. However, the protocol published in the British Medical Journal (BMJ), suggests the original intention had always been to disseminate the clincial data to participants in the study and to the wider public via an open access web-site, appropriate conferences and medical journals.

A more comprehensive overview of the study results was presented at the UWE Conference & Exhibition Centre in Bristol on the 29th November. Speakers included Dr Jerry Nolan, Dr Jas Soar, Prof Jonathan Benger, Dr Matt Thomas, Dr Janet Brandling, Dr Sarah Voss and Mr Dave Coates.

The results showed no significant differences in important clinical outcomes between the use of a supraglottic airway (SAD) and usual practice (principally tracheal intubation) during OHCA. However, the trial was insufficiently powered to detect small differences in mortality. The i-gel® was superior to the LMA Supreme® on several measures, including compliance, adverse events and staff feedback. The investigators are proceeding to a large-scale trial of i-gel® versus tracheal intubation in OHCA.

For the record, the survival to hospital discharge was as follows:

     • i-gel® 10.3%
     • LMA Supreme® 8.0%
     • Usual practice 9.1%

     (p=0.73)

Survival to 90 days is shown below:

     • i-gel® 9.5%
     • LMA Supreme® 6.9%
     • Usual practice 8.6%

     (p=0.65)

Data was also presented on neurocognitive and quality of life outcomes, as well as successful device placement. There was also interesting data regarding the number of arrests attended by each paramedic (March 2012 to February 2013), which ranged from 0-11, with a mean of 3.6 arrests per paramedic. 15 paramedics did not attend any arrest during the study period. There were presentations confirming how the airway was actually managed in practice and feedback from the paramedics that participated in the study.

Successful aspects of REVIVE included proof of the feasibility of a cluster randomised trial of airway intervention in OHCA and the collection of valuable data to inform a full trial. It also demonstrated the strong support of paramedics and informed statistical calculations for a larger study. So, what next?

REVIVE 2

Professor Jonathan Benger, in a presentation entitled, ‘Further research: REVIVE 2’, confirmed the aims of REVIVE 2 as identifying differences in the primary outcome of modified Rankin Scale (mRS) at hospital discharge: good recovery (0-3) versus poor recovery/death (4-6) and differences in:

• mRS at 3 and 6 months following OHCA
• Quality of life at discharge, 3 months and 6 months
• Cognitive function at 3 and 6 months
• ROSC
• Length of stay
• Ventilation success, regurgitation and aspiration
• Loss of a previously established airway

Comparative cost effectiveness of the i-gel® and intubation, as well as the views and preferences of paramedics is also to be assessed.

It is intended the design will be a cluster randomised trial (by paramedic), with an airway algorithm for each arm. Clinical need will always take precedence and there will be an economic analysis, as well as patient and public involvement. An outline bid has been successful, and a full proposal is to follow (5th February 2014). It is intended for the trial to run for 45 months, from October 2014 to June 2018.

REVIVE 2 will need approximately 1,300 paramedics. This will probably require the inclusion of three or four large UK ambulance trusts. It is estimated the cost for REVIVE 2 will be £2 million. The investigators are ready to begin.

Four and a half years (probably 5 years before the results are reported) may seem a long time to wait for the conclusion of REVIVE 2, but given the lack of high level data currently available regarding the best airway device to use during the initial phase of OHCA, it will be worth the wait.

Use of SADs in the prehospital setting – a new review

Ostermayer and Gausche-Hill, in their review paper, ‘Supraglottic airways: The history and current state of prehospital airway adjuncts’, to be published in Prehospital Emergency Care, provide a much welcome overview on the use of supraglottic airways (SADs) in what can often be a difficult and challenging setting.

The paper begins by confirming that the widespread adoption of SADs in prehospital care ‘directly stems from their ease of use, simplicity of training, predictability, and speed of insertion’. It continues with a brief history of the use of SADs, particularly the Laryngeal Mask Airway, in the prehospital setting and includes individual overviews of a number of devices, including the Combitube®, King LT®, LMA Fastrach® and Intersurgical i-gel®.

There is acknowledgement that whilst SADs do not, in the words of the authors, provide ‘definitive airway management’, some of the newer devices do incorporate higher seal pressures than earlier options and the ability for gastric decompression, which ‘may significantly decrease aspiration risk’.

In anaesthesia circles in particular, a new classification of SADs into 1st and 2nd generation devices has gained considerable popularity and helped to highlight important differences between devices. In a review article by White et al, entitled, ‘A critique of elective pediatric supraglottic airway devices’, a 1st generation device was described as a ‘simple airway tube’ and 2nd generation as a device that ‘incorporates specific design features to improve safety by protecting against regurgitation and aspiration.’

Of course, as mentioned in an earlier blog post on the classification of supraglottic airways, designation as a 2nd generation device does not in itself confirm superiority of performance, but the classification does provide useful information about basic product design characteristics, such as whether the device incorporates a mechanism for the management of regurgitant fluid. These are important considerations when deciding the most appropriate SAD to use in the pre-hospital setting.

Discussion on the use of airway devices in the austere environment states that data collection from Combat Support Hospitals in 2008 demonstrated that 86.3% of prehospital managed airways were managed with an Endotracheal tube (ETT), 7.2% with an Esophageal Tracheal Combitube (ETC) and 0.7% with an LMA, and that, ‘although the ETC is the standard rescue airway device for the U.S. Army, poor skill retention has been demonstrated with the device among medics.’

RSA or Rapid Sequence Airway placement, the insertion of an alternative airway, such as a SAD, after pharmacological treatment with a paralytic and sedative is discussed. This is an important subject and Ostermayer and Gausche-Hill confirm that no trials have yet compared the risks and benefits of drug-assisted SAD placement to non-drug-assisted placement.

The final section of the review takes a look at airway management in Out-of-Hospital Cardiac Arrest (OHCA). Of particular interest is a reference to a Japanese study which looked at neurological outcomes in patients where an ETT was used, compared to either a SAD or Bag Valve Mask (BVM). The results are interesting, but it is important when reviewing such studies to consider the SADs that were used. Results are likely to be quite different for 2nd generation SADs such as the i-gel, compared to a 1st generation device such as a standard Laryngeal Mask Airway. In some countries like the UK, devices such as the Combitube® are now rarely, if ever used. This issue is discussed in more depth in my blog post, ‘Pre-hospital airway management for patients with OHCA’.

There are a couple of small errors in the ‘early view’ version of this paper. For example, in Table 1, the i-gel® is designated as reusable, whereas the device is in fact single use. No doubt these errors will be corrected in the final published version.

In summary, this review paper provides an interesting overview of the history and current state of prehospital airway adjuncts. The conclusion will reflect the thoughts of many with regard to this subject:

‘Since prehospital airway management devices largely evolve from the field of anesthesia, much of the medical literature regarding new devices focuses on the operating room. With the many obvious practical and clinical differences between these clinical settings, further studies in the prehospital environment are needed, specifically trials correlating neurologic outcome to supraglottic device’

Equally important will be to ensure that results for one type of SAD are not extrapolated to another with quite different design characteristics. Tempting as it may be to discuss SADs as if they are one homogenous group of devices, the reality, as this paper helps to highlight, is that the performance of each device can and will be quite different. One SAD is most definitely not the same as another. Further data regarding the use of SADs in the prehospital setting is eagerly awaited.

Use of SADs during neonatal resuscitation

In June this year, an interesting discussion article was published in Resuscitation by Schmölzer et al, entitled, ‘Supraglottic airway devices during neonatal resuscitation: An historical perspective, systematic review and meta-analysis of available clinical trials’.

This is a welcome review. Whilst The World Health Organisation (WHO) report that neonatal mortality rates have declined from 32 per 1,000 births in 1990 to 22 per 1,000 births in 2011, a reduction of over 30%, the proportion of child deaths which occur in the neonatal period has increased in all WHO regions over the last 20 years. In an analysis of neonatal mortality – situation and trends, WHO state that prematurity is the leading cause of newborn deaths and that up to two thirds of newborn deaths could be prevented if skilled health care workers perform effective health measures at birth and during the first week of life.

The WHO Guidelines on Basic Newborn Resuscitation 2012 confirm that globally, approximately a quarter of neonatal deaths are caused by birth asphyxia, defining birth asphyxia as the failure to initiate and sustain breathing at birth. The guidelines go on to state that ‘effective resuscitation at birth can prevent a large proportion of these deaths’.

Schmölzer et al state that the International Liaison Committee on Resuscitation (ILCOR) and various national guidelines all agree that, ‘mask ventilation is the cornerstone of respiratory support immediately after birth.’ However, delivery room studies have shown that mask ventilation is difficult and mask leak and airway obstruction are common. In light of this, it is interesting to consider, as Schmölzer et al have done, what role supraglottic airways might have in neonatal resuscitation and examine the current evidence base for their use.

Current neonatal guidelines, such as those issued by the American Heart Association (AHA), state that Laryngeal Mask Airways (LMs) have been shown to be effective for ventilating newborns weighing more than 2kg or delivered ≥ 34 weeks gestation, and that there are limited data on the use of these devices in small preterm infants <2kg or <34 weeks gestation. The AHA guidelines also confirm that, ‘A laryngeal mask should be considered if facemask ventilation is unsuccessful and tracheal intubation is unsuccessful or not feasible. The laryngeal mask has not been evaluated in cases of meconium-stained fluid, during chest compressions, or for administration of emergency intratracheal medications.’

Perhaps unsurprisingly, Trevisanuto et al reported that although 35% of Italian anaesthetists and 23% of paediatricians have experience with LMs for airway management in newborn infants, anaesthetists were more enthusiastic about the LM than paediatricians. Schmölzer et al confirmed that although there are various studies comparing LMs, randomised trials comparing the performance of each LM are warranted.

There is a meta-analysis of randomised trials (RCT) in the Schmölzer et al review, which concludes that, ‘Overall, RCTs have shown that initial respiratory support with a LM is feasible and safe. However, there is not enough evidence to recommend LM instead of mask ventilation for initial respiratory support in the delivery room and large randomised trials are warranted before the technique is widely applied.’

The review also discusses the potential of supraglottic airways as a conduit for the administration of surfactant. An important subject, particularly given that surfactant administration via an ET tube has been associated with a series of adverse events. The review notes that, ‘although pilot data are promising, the current available evidence suggests that surfactant administration via laryngeal mask should be limited to clinical trials.’

At the 54th Annual Meeting of the European Society for Paediatric Research in Porto in October this year, three posters are being presented regarding the use of supraglottic airways in neonatal resuscitation. The first is entitled, ‘The relationship between successful insertion of a neonatal sized i-gel and a health care provider’s profession or experience’, by Sugiura et al from Shizuoka, in Japan. The second, from the same group of investigators, is entitled, ‘Randomised controlled study comparing a neonatal sized i-gel and the Laryngeal Mask Airway in a neonatal resuscitation mannequin.’ The third is entitled, ‘Higher success rate and operator satisfaction with i-gel laryngeal mask airway compared to face mask: A mannequin study of neonatal resuscitation in Uganda’, by Pejovic et al, from Stockholm in Sweden, Padua in Italy, Kampala in Uganda and Bergen in Norway.

It will not be possible to draw any conclusions from these posters, so the authors will no doubt conclude that further research is required. Of significance is the potential benefits of using supraglottic airways during neonatal resuscitation compared to a BVM or ET tube being discussed and studied, and the recognition that all supraglottic airways are not the same.

The latter point is important. Evidence for one supraglottic airway should not be extrapolated to another device with different design characteristics.

Further data regarding the potential use of supraglottic airways in neonatal resuscitation is awaited with great interest.

The i-gel SGA for prehospital airway management in a UK ambulance service

As previously reported on this blog page, the optimum method for management of the airway during cardiac arrest (CA) continues to be the subject of lively debate. The European Resuscitation Council (ERC) guidelines confirm that ‘There are no data supporting the routine use of any specific approach to airway management during cardiac arrest. The best technique is dependent on the precise circumstances of the cardiac arrest and the competence of the rescuer.’

With regard to the use of supraglottic airways (SADs) for CA, the call went out in an editorial entitled ‘Airway Management for out-of-hospital cardiac arrest – more data required’, published in 2009 in Resuscitation by Nolan and Lockey for high quality randomised controlled trials (RCTs) of the use of SADs for cardiopulmonary resuscitation (CPR). The REVIVE airways study process is an attempt to provide just such evidence by conducting a randomised comparison of the ventilation success of two 2nd generation supraglottic airways, i-gel® and the LMA Supreme®, in the initial airway management of OHCA compared to current practice, which is expected to be tracheal intubation. The REVIVE team published an initial report in the BMJ on the feasibility of such a study protocol earlier this year. A full trial is expected to follow.

In the meantime, healthcare professionals are still faced with the dilemma of which airway device to use for CPR, so any new data or evidence in this area, even if it is not high level, is likely to be of interest.

Duckett et al have just published the results of two retrospective clinical audits in the Emergency Medicine Journal, reviewing the use of basic and advanced airway management techniques within the UK North East Ambulance Service NHS Foundation Trust (NEAS) for cardiac arrests, entitled, ‘Introduction of the i-gel supraglottic airway device for prehospital airway management in a UK ambulance service.’

The audit confirmed that a range of basic and advanced airway management techniques are being successfully used to manage the airways of CA patients in NEAS and that i-gel is emerging as a popular choice for maintaining and securing the airway during pre-hospital CPR.

The success rates for i-gel insertion at 94% and 92% were higher than for the endotracheal tube (ETT) at 90% and 86%. In determining these results, the Quality Improvement Officer audited whether the technique used had been documented by the crew as ‘successful’ or ‘unsuccessful’, but no further details are provided in this report as to how success or failure was determined. Any additional relevant documentation which may indicate problems such as regurgitation, aspiration or trauma provided by the paramedic and/or the receiving A&E department were also considered. The abstract reports that ‘The re-audit indicated an upward trend in the popularity of i-gel; insertion is faster with a higher success rate, which allows the crew to progress with the other resuscitation measures more promptly.’

In light of this new data, it is interesting to note that an addition to the i-gel product range, specially designed for use during resuscitation, is also now available. The i-gel O2 Resus Pack (figure 1) contains a modified i-gel with a supplementary oxygen port.

figure 1

figure 1

It also includes a sachet of lubricant for quick and easy lubrication of the i-gel O2 prior to insertion, an airway support strap to secure the i-gel O2 in position and a suction tube for insertion through the gastric channel to empty the stomach contents (figure 2)

figure 2

figure 2

The i-gel O2 has been designed to facilitate ventilation as part of standard resuscitation protocols such as those designated by the ERC.

However, the i-gel O2 incorporates a supplementary oxygen port, permitting use for the delivery of passive oxygenation or Passive Airway Management (PAM), as part of an appropriate CardioCerebral Resuscitation (CCR) protocol. The use of passive oxygenation is discussed in an earlier blog post, Should we be passive about oxygenation?