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Journal of Anesthesia

https://doi.org/10.1007/s00540-020-02780-0

ORIGINAL ARTICLE

Comparison of the standard and triple airway maneuvering


techniques for i‑gel™ placement in patients undergoing elective
surgery: a randomized controlled study
İlkay Baran Akkuş1 · Fatma Kavak Akelma1 · Merve Emlek1 · Derya Özkan1 · Jülide Ergil1 · Reyhan Polat1

Received: 23 December 2019 / Accepted: 16 April 2020


© Japanese Society of Anesthesiologists 2020

Abstract
Purpose  The i-gel is a supraglottic airway device with non-inflatable cuff which can suffer insertion failure if its stand-
ard placement technique is implemented. The aim of this study was to compare the placement technique proposed by the
manufacturer of i-gel with the triple airway maneuver in terms of successful device insertion time and first-attempt success.
Methods  After ethics committee approval, 103 ASA I–III patients were randomly allocated to the standard or triple airway
maneuver groups. In the standard Group, the i-gel was inserted in the sniffing position while, in the triple group, it was
inserted using the triple airway maneuver consisting of head tilt, jaw thrust, and open mouth. The time taken for successful
insertion, first-attempt success rate, i-gel position, airway complications, and hemodynamic responses were assessed.
Results  Between the two groups patient characteristics were similar. Time for successful insertion was significantly shorter
in the triple group (20 ± 7 s) than with the standard technique (32 ± 11 s; p < 0.001). Successful insertion at the first attempt
was 78% and 92% for the standard and triple group, respectively (p = 0.092). The i-gel position, airway complications, and
hemodynamic responses were similar in both groups.
Conclusion  The triple airway maneuver required less i-gel insertion time as compared with the standard placement tech-
nique. First-attempt success rates were similar with both techniques, although the triple airway maneuver was superior to
the standard method as a rescue technique in failed insertions. We therefore recommend use of the triple airway maneuver
in i-gel insertion.

Keywords  I-gel · Triple airway maneuver · Insertion

Introduction decrease morbidity when compared with other supraglot-


tic airway devices [6–8]. Nevertheless, i-gel is not without
The i-gel (Intersurgical Ltd., Wokingham, UK) is a second- drawbacks. Given its slightly rigid structure prior to expo-
generation, single-use supraglottic airway device (SAD) sure to body temperature and lack of a pilot balloon to lower
with non-inflatable cuff designed to achieve rapid and reli- the cuff pressure, the placement of the i-gel using the stand-
able airway control [1–3]. Besides airway maintenance, it is ard method may, in some cases, pose difficulties. Complica-
also used as a conduit for fiberoptic intubation in patients tions associated with i-gel insertion have been previously
with difficult airways. reported [9, 10].
The placement of supraglottic airway devices can be In cases where the i-gel cannot be inserted with the
challenging, and the i-gel has been shown to increase first- standard technique, manipulations such as the application
attempt success rates [4, 5], shorten insertion time, and of gentle force to insert the device or rotate it in various
directions are sometimes used and this increases the number
* İlkay Baran Akkuş of insertion attempts. These manipulations may also increase
ilkayb@hotmail.com the risk of oropharyngeal trauma which can decrease the
1
success rate of subsequent attempts [11]. Also, in certain
Department of Anesthesiology and Reanimation, University patients, insertion may prove difficult and the tongue can get
of Health Sciences, Diskapi Yildirim Beyazit Trainig
and Research Hospital, Sehit Ömer Halisdemir Str, caught by the i-gel therefore the triple airway maneuver may
06110 Dıskapı‑ Altındag, Ankara, Turkey

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Journal of Anesthesia

provide a larger space for the i-gel and prevent this interac- pressure and heart rate values were recorded. Patients were
tion with the tongue [10]. preoxygenated with facemask ventilation an inspired oxy-
The triple airway maneuver is an alternative method that gen fraction ­(FiO2) 80% until an end-tidal oxygen satu-
combines the head tilt-chin lift, jaw thrust, and open mouth ration 90% was obtained. Induction was performed with
maneuvers together to achieve airway patency. As anesthe- propofol 2–2.5 mg/kg and fentanyl 1.5–2 µg/kg, and neuro-
siologists, we use this maneuver to shift the tongue forward muscular blockade was achieved with rocuronium 0.6 mg/
in our daily practice and we hypothesized that setting the kg. Anesthesia was maintained using 1.5–2% sevoflurane
tongue aside could be a significant advantage during i-gel in 50% oxygen–air mixture and remifentanil at a dose of
insertion; in particular, the triple airway maneuver could 0.02–0.2 µg/kg/min.
provide increased pharyngeal room for the i-gel with its non- The i-gel was inserted when the BIS value was between
inflatable cuff. Our specific hypothesis was that implement- 40 and 60. Additional propofol doses of 0.5–1.0 mg/kg were
ing the triple airway maneuver as the first-attempt method infused during the second and third attempts when required
would increase the success of i-gel placement, shorten the to keep the BIS value between 40 and 60. Size selection and
time it took, and reduce complication rates. The primary aim insertion of the i-gel device were according to the manu-
of the study was therefore to compare first insertion success facturer’s recommendations [1]. Before insertion, the cuff
and clinical performance between i-gel insertion using the was lubricated using a water based lubricant. The i-gel was
standard and triple airway maneuver techniques. inserted in the sniffing position with gently pressing the
chin down in the Standard Group, and by the head extended,
mouth open and chin lifted upward and forward in the Triple
Methods Group. The lubricated i-gel was grasped along the integral
bite block. The i-gel cuff outlet was facing the chin of the
This randomized controlled trial was conducted between patient. The leading soft tip was introduced into the mouth
December 2018 and February 2019 after obtain- towards the hard palate, and the device was glided down-
ing the approval of the institutional ethics committee wards and backwards along the hard palate until a definitive
(25.12.2017–44/12). All participants provided written resistance was felt [1, 12].
informed consent for participation in the trial. The study Two attempts were allowed before the technique was con-
was registered at ClinicalTrials.gov (NCT03542032). sidered a failure. When the first attempt failed, the same
American Society of Anesthesiologists (ASA) I–III technique was applied with a different size i-gel. The deci-
patients who were aged 18–75, weighed 50–90 kg, and were sion to increase or decrease the size of the i-gel was made by
scheduled for elective urological or orthopedic surgery with the attending anesthesiologist, based on clinical judgment.
an expected surgical duration of less than two hours were When two attempts with the same technique failed the other
considered for inclusion. Patients were excluded if they were technique was used as a rescue technique with the initial
pregnant, at risk of aspiration, or had a mouth opening of i-gel size. Finally, if all three attempts failed, tracheal intuba-
less than 2.5 cm, a body mass index greater than 35 kg/m2, tion was performed.
a lung disease, or a pathology of the neck or upper respira- Effective ventilation was defined as the presence of an
tory tract. The i-gel was inserted by the same anesthesiolo- end-tidal carbon dioxide waveform and simultaneous chest
gist who was experienced in the management of supraglot- movement. Ineffective ventilation was defined as an absent
tic airway devices (> 300 i-gel insertions). Patients were capnography trace, inadequate chest movement, peak airway
randomized to the standard insertion (standard group) and pressure greater than 30 ­cmH20 or a leak volume greater
triple airway maneuver (triple group) groups using a com- than 25% of the set-inspired tidal volume. Insertion time
puter-generated random number table. Demographic vari- was defined as the time between picking up the i-gel and
ables—age, sex, body mass index (BMI), and ASA physical obtaining effective ventilation. After obtaining an effective
status—were recorded. Airway anatomy was assessed with airway, the device was connected to a circle breathing sys-
the modified Mallampati score, thyromental distance, inter- tem (Primus, Drager, Lubek, Germany). Leak pressure and
incisor distance, measurement of the neck circumference, leak percentage were assessed right after the i-gel placement
and the upper lip biting test. and at 15 min after placement while the anesthesia circuit
All patients were required to fast for at least 6 hours was temporarily closed. Leak pressure was measured and
before surgery, and none of them received any premedi- recorded following a fresh gas insufflation of 5 l/min and
cation. We used routine monitoring consisting of pulse recording continued until an audible leak was remarked or
oximetry, electrocardiography, end-tidal carbon diox- until airway pressure plateaued. Airway pressure was not
ide ­( ETCO 2), and non-invasive blood pressure, as well allowed to exceed 40 cmH2O [13]. Leak volume was defined
as Bispectral index monitoring (BIS, VistaTM Aspect as the difference between the set-inspired and expired tidal
Medical Systems, New–ton, MA, USA). Baseline blood volumes.

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Journal of Anesthesia

Heart rate and mean arterial pressure were recorded at Selected


1, 3, and 5 min after the insertion of the i-gel. Any adverse 103

events such as desaturation (peripheral oxygen saturation


­(SpO2) < 92%), airway obstruction, coughing, gagging, Excluded
Eligible
laryngospasm and airway trauma (defined as blood staining 5

on i-gel at removal) were noted. Laryngeal positioning of


the i-gel was assessed by fiberoptic view (2.8 mm; Olympus, Included
Tokyo, Japan). The view via the airway channels was rated 98

as follows: Grade 1, only vocal cords visible; Grade 2, only


arytenoids visible; Grade 3, only epiglottis visible; Grade 4,
no laryngeal structures visible [6, 11]. Standart Triple
Sevoflurane and remifentanil were discontinued at the end 49 49

of the surgery and the airway device was removed following


successful mouth opening to verbal command. The interview Failed Failed
1st trial 1st trial
was conducted in the post-anesthesia ward by nurses who 11 4

were blind to study groups with regards to the presence or


absence of sore throat. Succeded Succeded
The primary aim of the study was to compare first time 38 45

insertion success rate and insertion time between the stand-


ard and triple airway maneuver techniques. Secondary out-
Failed 2nd trial Failed 2nd trial
come measures were the incidence of airway complications, 10 3
hemodynamic responses to insertion and grade of view on
fiberoptic inspection of the larynx. Succeded Succeded
1 1

Statistical analysis
3rd trial Failed 3rd trial Failed
Technique intubated Technique intubated
change 2 change 3
Statistical analyses were performed using the IBM SPSS
for Windows Version 22.0. Normality of continuous data
was assessed using one sample Kolmogorov Smirnov test. Succeded Succeded
0
8
Numerical variables were summarized as mean ± standard
deviation and categorical variables as frequencies and per-
Fig. 1  Study population flowchart
centages. Homogeneity of variances was tested by Levene
test. Two group comparisons were conducted using inde-
pendent samples t test for normally distributed data and patients’ characteristics and airway characteristics of these
Mann Whitney U for skewed data. Categorical variables patients are summarized in Table 1. Groups were similar in
were compared using the chi square or Fisher exact test. terms of age, gender, body mass index, ASA, Mallampati
Repeated measures ANOVA was performed to identify score, neck circumference, mouth opening and thyromental
between and within group differences. Pairwise compari- distance (p = 0.081).
sons were performed using the Bonferroni test. A P value Insertion time was significantly shorter in triple group
less than 0.05 was considered statistically significant. We than in standard group (p < 0.001). The first attempt success
used the insertion time to calculate the sample size in the rate was similar between insertion methods [45/49 (92%) vs.
pilot study (Group Standard n = 8, 26 ± 11 s; Group Triple 38/49 (78%); p = 0.092] (Table 2). The number of require-
n = 8, 20 ± 7 s). The sample size came out to be 49 patients ment for i-gel size change during the second attempt was
in each group at a power of 95% and alpha error of 0.05. also similar between the groups (p = 1). The triple maneuver
Considering the possibility of drop outs from the study, we was successful as a recue technique in the third attempt for
decided to include 104 patients. the eight of the ten failed patients in the standard group.
However, the standard technique was not successful as a
rescue technique in any of the failed cases in the triple group
Results in the third attempt (p = 0.035). Effective ventilation for the
remaining failed cases was established using endotracheal
A total of 103 patients were included in the study of these intubation (Standard group n = 2; Triple group n = 3).
four had a cervical pathology and two refused to partici- Patients who failed the standard method in the first two
pate. The study was completed with 98 patients (Fig. 1). The attempts but who succeeded with the triple airway maneuver

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Table 1  Characteristics of patients and procedures and airway char- were assessed for potential risk factors for difficult supra-
acteristics glottic airway device placement. Accordingly, eight patients
Group stand- Group triple (n = 49) had a neck circumference greater than 40 cm, five had a BMI
ard (n = 49) between 30 and 35 kg/m2 and three between 22 and 30 kg/
m2, one patient had a mouth opening less than 5.5 cm and
Age (years) 51 ± 16 47 ± 14
six patients were male.
Gender female n (%) 24 (49%) 24 (49%)
There was no difference leak percentages between the
BMI kg/m2 28 ± 4 29 ± 3
groups. (Table 2). However, within-group analysis revealed
Mallampati Score n (%)
that leak percentage was significantly reduced with time in
 1 15 (31%) 15 (31%)
both groups (p < 0.001). Patients were compared in terms
 2 24 (49%) 20 (41%)
of leakage pressure and leakage pressure was higher in the
 3 9 (18%) 13 (26%)
triple group in both time periods (p = 0,012, p = 0.027).
 4 1 (2%) 1 (2%)
Intra-group analyzes showed that leakage pressure increased
ASA n (%)
significantly over time in the standard group (p = 0.031).
 1 10 (20%) 18 (37%)
Fiberoptic findings were similar between the groups
 2 33 (67%) 29 (59%)
(Table 2).
 3 6 (12%) 2 (4%)
The incidence of postoperative sore throat did not dif-
Neck circumference (cm) 40 ± 4 40 ± 5
fer between the groups (Table 3). Five patients in standard
Inter-incisor distance (cm) 6 [4–7] 6 [5–7]
group but none of the patients in triple group had blood
Thyromental distance (cm) 6 [4–8] 6 [5–7]
staining on the device at removal (p = 0.056). No hypoxia,
BMI Body mass index, ASA american society of anesthesiologists sta- laryngospasm, or airway obstruction was observed dur-
tus ing the placement or removal of the i-gel. Hemodynamic
parameters remained similar between the groups (p = 0503,
Table 2  Characteristics of successful airway insertion p = 0948).
Group standard Group triple p value
(n = 49) (n = 49
Discussion
Insertion time (s) 32 ± 11 20 ± 7  < 0001a
Successful insertion rate,
We found that the triple airway maneuver decreases i-gel
n (%)
insertion time as compared with the standard technique. We
 First attempt 38(78%) 45(92%) 0092
also demonstrated that it could be used as an alternative
 Second attempt (different 1 1 1
size) with regards to similar first insertion success rates, airway
 Third attempt (rescue 8 0.035a complications, and hemodynamic response.
method) Various placement methods have been introduced to
Failed 2 3 increase insertion success rates for supraglottic airway
Leak pressure (­ cmH2O) devices. A survey of anesthesiologists regarding the inser-
 1 20 [10–40] 26 [10–40] 0012a tion of laryngeal mask airways (LMAs) revealed that only
 2 24 [10–40] 29 [10–40] 0027a 30–34% of respondents followed the manufacturer’s recom-
 p 0,031a 0180 mendations, and that 36–42% did not use the standard inser-
Leakage percentage (%) tion technique [14].Several studies have assessed alternative
 1 14 [6, 20] 14 [4, 20] 0333 methods in increasing first attempt success rates. Two such
 2 12 [1 20] 10 [1 18] 0391 studies demonstrated that the rotation technique provided a
 p  < 0001a  < 0001a higher first attempt success rate than the standard insertion
Brimacombe score n (%) [11, 15]. Poor dentition was raised as a relative contraindi-
 Grade 1 5 (11%) 6 (13%) 0785 cation for this method [16]. The effect of prewarming the
 Grade 2 11 (24%) 7 (16%) i-gel on insertion time, ventilation, and sealing pressure has
 Grade 3 9 (20%) 9 (20%) been assessed but failed to demonstrate any advantage [17].
 Grade 4 9 (20%) 23 (51%) In the present study, we choose to use the triple airway
a maneuver to enhance the placement of i-gel because, this
 Statistical significance
technique does not require preparation and all anesthesi-
ologists are familiar with this maneuver. The triple airway
maneuver has long been used for the placement of several
supraglottic airway devices [12, 18, 19]. Using the LMA

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Journal of Anesthesia

Table 3  Comparison of Group standard Group triple p value


incidence of adverse events (n = 49) (n = 49)
between placement techniques
Sore throat 2 (4%) 1 (2%) 1000
The presence of blood on the i-gel 5 (11%) 0056
Cough in placement 5 (11%) 1 (2%) 0203
Cough while removing 5 (11%) 1 (2%) 0203
Heart rate beat/mean
 Before insertion 75 ± 13 77 ± 11 0503
 5 min after insertion 71 ± 13 71 ± 12 0948
Mean arterial pressure, mmHg
 Before insertion 83 ± 13 85 ± 12 0634
 5 min after insertion 78 ± 12 76 ± 11 0571

Unique Airway, for example, Eglen et al. compared three These rates are comparable with previous studies reporting
insertion techniques and found that first-attempt insertion 0–4% insertion failure rates [24].
success rates were 88.3% for both the standard and triple The i-gel insertion time in the presenting study may seem
airway maneuver methods [19]. longer that some of the previous reports [23, 25–28, 30]. We
In the presenting study, the success rates of first attempt consider that this difference is related to how we measured
placement were found to be similar in the standard and insertion time. The i-gel could be placed after second and
triple airway maneuver groups, 78% vs. 92% respectively. third attempts with a different size or rescue maneuver in 9
However we detected significantly increased success rates patients in the standard group whereas this was the case only
with the triple maneuver when used as rescue method at the in one patient in the triple group. We included the time taken
third attempt. We consider that this difference in our results by the second and third attempts in the i-gel insertion time
compared to those of Eglen et al. is related to the fact that and confirmed the placement with adequate chest move-
the i-gel differs from the other supraglottic airway devices ment and end tidal CO2 tracing. This methodology may
as it does not have an inflatable cuff. During insertion of have increased the mean i-gel insertion time in the standard
the LMA a wider pharyngeal space may not offer as much group. In fact, i-gel insertion time is variable in previous
advantage as the i-gel because of the presence of a deflatable studies. The mean time to achieve an effective airway using
cuff. A deflatable cuff provides that the supraglottic airway i-gel has been reported to be between 7 and 34.7 s [11, 22,
device is softer and can change shape which in turn increases 23, 25–30]. In our study, we found the insertion time in the
the ease of insertion through narrow spaces. standard group similar to Kim et al. which reported 34.7 s.
First attempt insertion success rate with supraglottic air- i-gel insertion time [29]. In the studies of Damodaran and
way device has been reported to vary between 62 and 97% Lee, there is no data about the inclusion of the duration of
[13, 20–23]. In the presenting study results from both groups the 2rd and 3rd trials in insertion time in cases which i-gel
were consistent with previous reports. could not be placed in the first attempt [25, 26]. Further-
When an anesthesiologist fails to insert the i-gel using more, in another study of Kim et al. the authors reported
the standard placement method, other manipulations are 26.9 s i-gel insertion time with the standard method, this
often used, such as neck extension or flexion, chin lift, jaw time is close to ours, despite the authors did not include the
thrust, and pushing or pulling the device. Repeated insertion time required for the second and third attempts [11].
attempts increase the risk of complications, including bleed- Owing to its unique thermoplastic elastomer structure,
ing and edema, and each failed attempt reduces the likely the i-gel adapts to the supraglottic tissue by stretching with
success of subsequent efforts [11]. In the current study, the body temperature over time [31], and this adaptability is
triple airway maneuver was successful in eight patients for associated with a decrease in leakage percentage over time.
whom the standard i-gel insertion method had twice failed. We observed this pattern in the current study. The leakage
The standard method, on the other hand, was not successful pressure measured during i-gel insertion is usually between
in any of the patients for whom the triple airway maneu- 10–40 ­cmH2O [13], and pressures below 5 cmH2O have
ver had failed. This observation demonstrates that the triple been deemed to represent unsuccessful placements [24]. In
airway maneuver is a successful rescue technique in failed our study, higher leakage pressures were measured in the
insertions. triple group than in the standard group, and this may actually
Eventually, the insertion failure rate using the standard be an advantage in particular clinical situations where higher
and triple airway methods were 4% and 6%, respectively. leakage rates are required such as laparoscopic surgery.

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Journal of Anesthesia

The i-gel differs from many other supraglottic airway Conclusion


devices in that it does not have an inflatable cuff [32]. Its
non-inflatable structure has many advantages, but it is not We demonstrated that the triple airway maneuver required
without its limitations; device placement against the phar- less i-gel insertion time as compared with the standard
ynx may, for example, be restricted by the tongue [15], insertion technique. We also found that the triple airway
and related complications such as tongue trauma, frenu- maneuver and standard methods provided similar first
lum hemorrhage and edema, and bilateral lingual nerve insertion success rates and yielded similar airway com-
damage have been reported in the literature [9, 10]. The plications. Finally, the triple maneuver was superior to
use of the triple airway maneuver may reduce the rate of the standard method as a rescue technique in failed i-gel
such complications as it shifts the tongue aside providing insertions. We therefore recommend the use of the triple
direct access to the pharynx. In the current study, we did airway maneuver in i-gel insertion.
not observe any serious complications related to the use of
this maneuver, although blood staining on the device was
observed at removal in five of the patients in the standard
group (none of the triple group). References
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