Anaesthesia, 2008, 63, pages 991995 doi:10.1111/j.1365-2044.2008.05542.x .....................................................................................................................................................................................................................

APPARATUS

I-gel insertion by novices in manikins and patients*

N. M. Wharton,1 B. Gibbison,2 D. A. Gabbott,3 G. M. Haslam,4 N. Muchatuta1 and T. M. Cook5
1 Specialist Registrar, 2 Clinical Fellow, 5 Consultant, Royal United Hospital, Combe Park, Bath BA1 3NG, UK 3 Consultant, 4 Specialist Registrar, Gloucester Royal Hospital, Great Western Rd, Gloucester GL1 3NN, UK Summary

The i-gel, a novel supraglottic airway, has been proposed for use during cardiopulmonary resuscitation. We evaluated the performance of this device in manikins and anaesthetised patients when used by novices: medical students, non-anaesthetist physicians and allied health professionals all unfamiliar with the i-gel. Fifty i-gels were placed in manikins. Eighty-eight percent (44 50) were placed on the rst attempt with a median insertion time of 14 s (range 745). I-gels were placed in 40 healthy anaesthetised patients. Success on the rst attempt was 82.5% (33 40) and on the second attempt 15% (6 40). After three attempts there were no failures. Median insertion time was 17.5 s (range 7197). Median airway seal was 20 cmH2O (range 1340). One case of regurgitation and partial aspiration occurred. Our results suggest the i-gel is rapidly inserted in both manikins and patients by novice users and compares favourably to other supraglottic airways available. Further work determining safety and efcacy during cardiopulmonary resuscitation is required.
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Correspondence to: Dr B. Gibbison E-mail: ben@gibbison.com *Data from this paper has been presented at the Difcult Airway Society Annual Scientic Meeting 2007, Portsmouth, UK. Accepted: 9 March 2008

The i-gel (Intersurgical, Wokingham, UK) is a novel supraglottic airway device (SAD) designed for use during anaesthesia. It has a non-inatable cuff made from a gellike thermoplastic elastomer (Fig. 1). Early reports have tentatively proposed its use for airway management during cardiopulmonary resuscitation [1, 2]. It has features which may make it simple to insert for occasional users [3]. The design features are: 1 The absence of a cuff, obviating the need for cuff ination. 2 A widened, attened stem to act as a stabiliser within the buccal cavity and reduce the chance of axial rotation and thus malposition. 3 A ridge at the proximal end of the mask bowl, designed to sit below the tongue base to prevent the i-gel from moving upwards and out of position. 4 A semi-rigid stem and rigid bite block designed to enable easier insertion and reduce the chances of kinking. 5 An insertion depth gauge a black line on the stem indicating correct depth of insertion when lying between the incisors.
2008 The Authors Journal compilation 2008 The Association of Anaesthetists of Great Britain and Ireland

It also has features designed to separate the gastrointestinal and respiratory tracts: an airway channel connected to a 15 mm airway port and an oesophageal channel through which a gastric tube may be passed (size 14Fr for size 5 i-gel and 12Fr for sizes 3 and 4 i-gel). There is controversy regarding non-anaesthetists undertaking tracheal intubation [4, 5]. Reported failure rates by non-anaesthetists may exceed 30% [6] and be associated with prolonged insertion times. The European Resuscitation Council (ERC) published a revised edition of resuscitation guidelines for cardiac arrest in November 2005 [7] which included increased emphasis on use of supraglottic airways to establish and maintain the airway when tracheal intubation was not immediately feasible. Such airways include the laryngeal tube (LT), laryngeal tube suction (LT-S) (both VBM Sulz, Germany), the Combitube (CT) (Tyco-Kendall, Manseld, MA, USA), the Laryngeal mask airway-Classic (cLMA), ProSeal (PLMA) and the Intubating LMA (ILMA), (all Intavent Orthox, Maidenhead, UK). Placement of supraglottic airways is not always successful [8].
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N. M. Wharton et al. I-gel insertion by novices in manikins and patients Anaesthesia, 2008, 63, pages 991995 . ....................................................................................................................................................................................................................

Figure 1 A size 4 i-gel with a gastric tube.

The i-gel has been recently introduced. Following formal evaluation in our department (unpublished data) we performed a study on manikins and anaesthetised patients to investigate the feasibility of its use for airway management by non-anaesthetists who were unfamiliar with the i-gel.
Methods

Regional Ethics Committee approval was gained. The study was split into two limbs: insertion of the i-gel in a manikin and insertion in anaesthetised patients. For governance reasons the evaluation of performance in a manikin was completed and analysed prior to deciding to continue with the evaluation in patients. The two limbs of the study were not linked and participants could take part in either or both evaluations. Evaluation in a manikin Written informed consent was gained from fty airway novices (medical students, non-anaesthetist physicians and operating department practitioners). Those who had received over 3 months training in anaesthesia were excluded from study. The participants placed a size 4 i-gel in an Airsim manikin (Trucorp, Belfast, UK). We chose this manikin as previous work had found this to be a well performing surrogate for use with SADs and the i-gel in particular [9]. After a demonstration of the use of the i-gel (following the manufacturers instructions) by one of the investigators, the participants attempted placement without any practice. The following details were recorded: number of attempts, success failure, ease of insertion, time taken for insertion (from picking up the i-gel to successful ventilation of the manikin lungs with a selfinating bag), number and type of airway manipulations required to aid insertion, and complications.
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Evaluation in anaesthetised patients Written informed consent was gained from forty nonanaesthetic medical and allied staff (criteria as above) and forty adult patients undergoing elective anaesthesia in which airway management with a SAD was planned. Patients were excluded if airway management with a SAD was not indicated or if neuromuscular blockade was planned. If the participant had not taken part in the manikin stage of the study, the same short demonstration of i-gel use was given by an investigator and the novice inserted an i-gel in the manikin once. Therefore, prior to insertion in the patient, each participant had performed one successful i-gel insertion in a manikin: a state we considered a minimum acceptable. The patients were anaesthetised using a technique of the anaesthetists choice, although use of neuromuscular blocking drugs was a contra-indication to entry into the study. In all cases anaesthesia included intravenous propofol and an intravenous opioid. Adequate depth of anaesthesia (unresponsive to voice, relaxed jaw and no response to jaw thrust) [10] was conrmed before i-gel insertion. Participants were then asked to the place the i-gel. In the early stages of the study, only size 4 i-gels were inserted, as these were the only size available from the manufacturer. The manufacturers state that this size performs well in most patients. This would appear to be the case from our published [1] and unpublished evaluations (unpublished data) and routine use in over 500 cases. Following the introduction of the size 3 and size 5 i-gels, the size of i-gel used followed the manufacturers instructions [3]. We recorded patient demographic data, number of insertion attempts, success or failure, ease of i-gel insertion, airway manipulations, time taken for insertion and complications of insertion. Time taken for successful ventilation was recorded from picking up the i-gel to successful ventilation of the lungs with the anaesthetic circuit reservoir bag (visible movement of the chest and square wave capnograph trace). Following insertion and successful ventilation, airway seal pressure was measured and a gastric tube was passed via the oesophageal port. Airway seal pressures were measured using the anaesthetic machine (Datex S 3 or S 5 ADU, Datex Ohmeda, Madison, WI, USA) by closing the adjustable pressure leak valve, administering a fresh gas ow of 5 litres per minute and allowing airway pressure to rise to a plateau or to a maximum of 40 cmH2O.
Results

Twenty eight ODPs, 15 trainee doctors and seven medical students took part in the manikin limb, while 33 ODPs, four medical students and three trainee doctors took part in the patient limb. No trainee doctor had
2008 The Authors Journal compilation 2008 The Association of Anaesthetists of Great Britain and Ireland

Anaesthesia, 2008, 63, pages 991995 N. M. Wharton et al. I-gel insertion by novices in manikins and patients . ....................................................................................................................................................................................................................

undertaken an anaesthetic job. Six novices (15%) took part in both limbs of the study. Evaluation in a manikin (n = 50) Fifty i-gels were placed. Eighty-eight percent (44 50) were placed on the rst attempt with a median insertion time of 14 s (range 745). One airway manoeuvre was used in 52% (26 50) of cases, two manoeuvres were used in 20% (10 50) and three in 4% (2 50) to aid placement. The most common manoeuvres were neck extension and chin lift, used in 34% (17 50) and 28% (14 50) of cases, respectively. Only one complication was reported, which was a signicant airway leak during assisted ventilation. Evaluation in anaesthetised patients (n = 40) Fourteen female and 26 male patients took part in the study with a median age 50.5 years (range 2286), median weight 78.5 kg (range 3898), all ASA 1-2. Thirty one size 4 i-gels and nine size 5 i-gels were inserted. The i-gel was successfully placed in 82.5% (33 40) on the rst attempt and in 15% (6 40) on the second attempt. One participant took three attempts to site the i-gel correctly. There were no failures. Median time to successful placement was 17.5 s (range 7197). One airway manoeuvre was used to aid placement in 45% (18 40) of cases, two manipulations in 17.5% (7 40), three in 5% (2 40) and four in 2.5% (1 40). The most common manoeuvre was neck extension, used in 57.5% cases (23 40). Median seal pressure was 20 cmH2O (range 13 45). When attempted, a gastric tube was passed into the stomach on rst attempt in 85% (28 33) cases. One patient, despite apparently adequate anaesthesia and airway placement, regurgitated stomach contents shortly after insertion of the i-gel. The i-gel indicated regurgitation as uid was visible in the drain tube. The device provided only partial airway protection, with a small amount of regurgitant uid entering the trachea. This necessitated removing the i-gel and intubating the trachea. This was reported to the research ethics committee and has been published elsewhere in the literature [11]. Minor hiccoughing was also recorded in one case. There were no episodes of laryngospasm, bronchospasm, airway bleeding, hypoxia or other important complications.
Discussion

Our study shows high success rates for insertion of the i-gel in both a manikin and in patients. While the use of the i-gel appears both intuitive and simple we included a manikin limb of the study to ensure that genuine airway novices could insert the i-gel in a manikin in an acceptable manner before proceeding to a patient study.
2008 The Authors Journal compilation 2008 The Association of Anaesthetists of Great Britain and Ireland

It is notable that performance in both limbs of the study were remarkably similar with 100% insertion success, > 80% rst time success and a median time for insertion that only differed by 3.5 s. The i-gel was deployed with minimal evidence of patient trauma. The i-gel has potential advantages over other methods of airway management by non-anaesthetists during cardiopulmonary resuscitation (CPR). Tracheal intubation is associated with signicant morbidity and mortality, particularly when performed by those who undertake the technique infrequently. Failure of tracheal intubation under optimum conditions has been reported in up to 30% of paramedic intubations [6]. Failure to recognise this represents a more clinically signicant problem. Rates of unrecognised tracheal tube misplacement are not denitively known, although reported rates are close to 25% [12]. For this reason tracheal intubation is no longer taught in detail on Resuscitation Council (UK) Advanced Life Support Provider courses. Supraglottic airways, which fail safe, offer an alternative, but occasional users can nd insertion problematic and this may prolong insertion times. Two recent studies of novice anaesthetic trainees found the median insertion times for the LMA-Classic to be 32 s (rst time success rate 80%, overall 95%) [13] and the ProSeal LMA (PLMA) 53 s (rst time success rate 73%, overall success rate 95%) [14]. Resuscitation guidelines increasingly emphasise the need to minimise interruption of cardiac compression while establishing a clear airway [7]. Data from this study indicate the i-gel can be placed both faster (18 s) and with higher success rates (rst time 83%, overall 100%) than reported in those studies. Further, in a manikin study, we recently demonstrated that the i-gel can decrease the time taken to establish an airway during CPR by up to 50% compared with the LMA-classic, PLMA or tracheal tube [15]. While our study was not primarily designed to compare i-gel insertion between manikin and patient, the similarity of performance is important for two reasons. First, it suggests that a manikin may be an alternative for some further i-gel studies that only examine insertion of the device. Second, it allows us to infer from our own manikin study during CPR, that the i-gel is likely to be swiftly deployed in vivo. Further study is indicated. The i-gel also offers the potential advantage over the LMA-Classic that its drain tube allows access to (and egress from) the gastrointestinal tract. The drain tube is designed to reduce gastric ination and the risk of regurgitation, but its efcacy is unproven. In one patient in this study the i-gel did not provide complete protection from aspiration, although the drain tube gave an early indication of regurgitation and allowed the majority of the stomach contents to exit harmlessly. We also
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N. M. Wharton et al. I-gel insertion by novices in manikins and patients Anaesthesia, 2008, 63, pages 991995 . ....................................................................................................................................................................................................................

have experience of the i-gel providing complete protection from regurgitation in two cases [11]. The most analogous supraglottic airway that also possesses this feature is the PLMA. This provides excellent protection from aspiration in both bench top and cadaveric studies [16, 17]. It is possible that the smaller and more distensible drain tube of the i-gel may be more easily overwhelmed by large ow rates. Whilst the PLMA certainly has more evidence for its efcacy in this area; on balance the advantage of faster insertion and therefore less interruption (or indeed delay to starting) of oxygenation may favour the i-gel. Further data is needed to conrm this. Seal pressures are comparable to that of the LMAClassic, but inferior to the PLMA [18]. This may limit the use of the i-gel when used during asynchronous chest compressions and in those with poorly compliant lungs. Further study is also needed to clarify this. Limitations of this study are mostly around the size of the study. It is too small to prove novices can insert the i-gel without complications. However it is essentially a proof of concept study, to determine whether a larger trial of the i-gel for airway management during resuscitation might be indicated. Use of differing groups of staff for i-gel insertion might be criticised, but we chose these groups as all are novices with minimal personal experience of practical airway management and none had previous experience of i-gel placement. We did not perform analysis of performance of different groups as the numbers in each group are too small to provide statistically robust data. We chose to allow only one successful insertion of the i-gel in a manikin before insertion in a patient: this being true whether the novice took part in both limbs of the study, or only in the patient limb. This might be considered by some to be inadequate training but the i-gel is intuitively and practically easy to use and for the device to be potentially useful in rst responders at a cardiac arrest it must be deployable with a minimum of training. This preliminary study suggests the i-gel may have a role for use by airway novices for primary airway management during cardiopulmonary resuscitation and perhaps when tracheal intubation fails. However, before a larger study is undertaken further work is needed to determine the ability of the device to protect the airway in patients who are not starved and to determine the efcacy of lung ventilation via an i-gel during asynchronous chest compressions.
Conict of interest

equipment for evaluation from other manufacturers and have been paid by Intavent-Orthox and the LMA Company (competitors of Intersurgical) for lecturing.
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Intersurgical provided the i-gels for this and other studies free of charge. Drs Cook and Gabbott have received free
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15 Gatward JJ, Thomas MJC, Nolan JP, Cook TM. The effect of chest compressions on the time taken to insert airway devices in a manikin. British Journal of Anaesthesia 2008; 100: 3516. 16 Miller DM, Light D. Laboratory and clinical comparison of the Streamlined Liner of the Pharynx Airway (SLIPATM) with the laryngeal mask airway. Anaesthesia 2003; 58: 13642.

17 Keller C, Brimacombe J, Kleinsasser A, Loekinger A. Does the ProSeal laryngeal mask airway prevent aspiration of regurgitated fluid? Anesthesia and Analgesia 2000; 91: 1017 20. 18 Cook TM, Lee G, Nolan JP. The ProSeal laryngeal mask airway: a review of the literature. Canadian Journal of Anaesthesia 2005; 52: 73960.

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