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Original Article

Conventional versus reverse insertion of i‑gel®


in overweight and obese patients – Interventional
randomised controlled trial

Address for correspondence: Sonali Ahuja, Gurpreeti Kaur, Kamakshi Garg, Anju Grewal
Dr. Kamakshi Garg, Department of Anaesthesiology, DMCH Ludhiana, Punjab, India
H No. 4, Professor Colony,
Barewal Road, Ludhiana,
Punjab - 141 012, India. ABSTRACT
E-mail: drkamakshigarg@
gmail.com
Background and Aims: The supraglottic airway device, i-gel, is used in obese patients for short- to
Submitted: 01-Sep-2022 medium-duration surgical procedures. Insertion techniques have contributed to the successful
Revised: 11-May-2023
and proper placement of i-gel in the first attempt. This study aims to compare two techniques for
Accepted: 18-May-2023
Published: 15-Aug-2023 successfully inserting i-gel in the first attempt in overweight and obese patients as measured by
oropharyngeal leak pressure (OLP). Methods: This interventional, randomised, controlled study
was conducted after ethical approval, and trial registration in overweight and obese patients.
Patients were randomised into two groups: In Group C, the conventional technique was used,
while in Group R, the reverse technique was used to insert i-gel. OLP, successful placement,
required manipulations, time taken for insertion, number of attempts, and intraoperative and
postoperative complications were studied. The collected data were analysed statistically.
Access this article online Results: The mean OLP (30.46 ± 3.76 vs. 32.12 ± 3.10 mmHg, P = 0.018) and the mean time of
insertion (16.42 ± 1.86 vs. 13.98 ± 1.97 s, P = 0.001) for conventional and reverse techniques,
Website: https://journals.lww.
com/ijaweb respectively, were statistically significant and favourable for Group R compared to Group C.
Successful placement of i-gel at the first attempt, ease of insertion, number of attempts and all
DOI: 10.4103/ija.ija_749_22
the manipulations except withdrawal and advancement were comparable in both the groups.
Quick response code
No postoperative complications were noted. Conclusion: The reverse technique significantly
favoured the actual OLP values and the mean insertion time. Successful placement of i-gel at the
first attempt was observed with both conventional and reverse techniques.

Key words: Airway management, i-gel, obese, oropharyngeal leak pressure, overweight,
supraglottic airway device

INTRODUCTION avoiding multiple insertion attempts. Minimal airway


handling prevents trauma to the oral cavity and requires
Obesity causes a physiologically and sometimes less time to secure the airway. This will avert episodes
anatomically difficult airway; therefore, managing of desaturation and other associated respiratory or
the airway and oxygenation in obese patients can haemodynamic complications. Preventing these
be challenging. Supraglottic airway devices (SADs) complications is necessary for obese patients owing to
are an excellent alternative to the endotracheal shorter safe apnoea time.[4-6]
tube (ETT) in securing the airway in obese
This is an open access journal, and articles are distributed under the terms of
patients.[1] i-gel® (a second-generation SAD) has been the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License,
which allows others to remix, tweak, and build upon the work non-commercially,
used in obese patients for short- to medium-duration as long as appropriate credit is given and the new creations are licensed under
surgical procedures. Due to its high leak pressure in the identical terms.

conjunction with easier positioning and faster insertion, For reprints contact: WKHLRPMedknow_reprints@wolterskluwer.com

it has been proven beneficial in obese patients.[2,3]


How to cite this article: Ahuja S, Kaur G, Garg K, Grewal A.
Conventional versus reverse insertion of i-gel® in overweight and
Insertion techniques contribute to the successful and obese patients – Interventional randomised controlled trial. Indian J
proper placement of i-gel in the first attempt, thereby Anaesth 2023;67:708-13.

708 © 2023 Indian Journal of Anaesthesia | Published by Wolters Kluwer - Medknow


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Ahuja, et al.: Reverse i-gel insertion in obese patients

The present study hypothesised that the reverse room (OR), all patients were positioned in ramped
technique of insertion would confer benefits in terms position, standard ASA monitoring was done, and
of better airway seal in obese patients in comparison baseline values were recorded. Intravenous (IV)
to the conventional insertion technique. The current 0.05 mg/kg midazolam and 10 mg metoclopramide were
study aimed to evaluate two different insertion administered. After preoxygenation with 100% oxygen
techniques for the successful placement of i-gel in for 3–5 min; anaesthesia was induced with IV 2 µg/kg
the first attempt in overweight and obese patients as fentanyl and 2–2.5 mg/kg 1% propofol titrated to loss
measured by an oropharyngeal leak pressure (OLP). of verbal response. Thereafter, IV 0.5 mg/kg atracurium
was administered for neuromuscular blockade.
METHODS After achieving adequate jaw relaxation, the airway
was secured by an appropriately sized i-gel using
This interventional, randomised, controlled study the technique randomly allocated to that patient. In
was conducted in a tertiary health care institute after Group C, the conventional technique was to insert
obtaining institutional ethics committee approval (vide i-gel, with the concave end of the device facing the
approval number BFUHS/2K21p-TH/5005 dated mandible in a pen-holding manner and advancing it
20 April 2020). The trial was registered at the Clinical further until it fitted over the larynx (Brain’s technique).
Trials Registry of India (vide registration number While in Group R, the reverse technique was used to
CTRI/2020/09/027780, http://ctri.nic.in). The duration insert i-gel, with the device’s concave end positioning
of the study was from October 2020 to September towards the hard palate, rotated by 180° after reaching
2021. Written and informed consent was obtained the oropharynx and further inserting it until it fitted
from all the patients for participation in the study and over the larynx (Guedel’s airway). Weight-based
use of the patient data for research and educational selection criteria were used to select the size of i-gel as
purposes. The study was carried out in accordance per the manufacturer’s instructions (size 3: 30–60 kg,
with the principles of the Declaration of Helsinki, size 4: 50–90 kg, size 5: >90 kg). The i-gel cuff was
2013. lubricated with a water-based jelly before insertion.
An anaesthesiologist with an experience in ≥100
Patients of the American Society of SADs insertions and ≥50 i‑gel insertions performed
Anesthesiologists (ASA) physical status I–III posted the procedure.
for elective surgical procedures lasting up to 120 min
in a supine position with body mass index (BMI) ≥23 The primary outcome was OLP; to measure it, the
and ≤40 kg/m², classified as overweight, obese class I fresh gas flow was calibrated to 3 l/min, and the circle
and II as per the Asian criteria of BMI for nutritional system’s adjustable pressure-limiting (APL) valve
status, were included in the study.[7] Patients with was closed. With no peak end-expiratory pressure,
known or predicted difficult airway, those posted for the minimum airway pressure was recorded for the
surgeries in the prone or lateral position, those with audible gas leak using a stethoscope at the lateral
any pathology of the upper respiratory tract, abnormal side of the thyroid cartilage. Airway pressures
head, neck or airway anatomy, presence of any were maintained at ≤40 cmH2O. Among secondary
significant acute or chronic lung disease, emergency outcomes, the successful placement of i-gel at the
surgeries, thoracic surgeries, neuro surgeries, cardiac first attempt was confirmed by gently squeezing the
surgeries, airway surgeries, cervical spine injury, reservoir bag and observing visible chest rise, bilateral
pregnant women and those who refused to participate chest auscultation and appearance of a square wave
were excluded from the study. end-tidal carbon dioxide (EtCO2) waveform. The time
of insertion was recorded from picking up the i-gel
One hundred patients were randomised into till the commencement of mechanical ventilation and
Group C (n = 50) and Group R (n = 50) by the appearance of a square wave capnograph.[8] The
computer-generated random numbers and allocation maximum time allowed for each attempt was 60 s.
concealment using opaque, sequentially numbered, A maximum of three attempts were allowed for the
sealed envelopes opened by an anaesthesiologist not insertion of each device. Any change in the device’s
involved in the study. size was also considered an attempt. It was regarded
as failed placement if, after three attempts at i-gel
Patients underwent routine preoperative assessment placement, the criteria for successful placement were
and standard fasting protocols. In the operating not met. The need to change the type of airway device

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Ahuja, et al.: Reverse i-gel insertion in obese patients

was also considered a failed placement. The number sample size of 50 patients per group was proposed to
of desaturation episodes, that is, peripheral oxygen identify a clinically related difference of 3 cmH2O with
saturation (SpO2) <90%, was noted, and the patients a standard deviation (SD) of 5 cmH2O in OLP based on
were ventilated with 100% oxygen using a face mask a previous study and a pilot study performed in our
till optimal SpO2 level (95%) was attained. This time institute using conventional and reverse techniques.
of ventilation was included in the effective airway This proposed sample size was computed with 0.05%
time.[9] alpha error, 80% power and a 10% dropout rate.

Any manipulations done during the insertion of the The data were expressed as mean ± SD and frequencies
i-gel, like gentle withdrawal, jaw thrust, chin lift, neck (regarding the number of cases). The Kolmogorov–
flexion, head extension or change in size, were noted. Smirnov test was employed to assess the normal
The anaesthesiologist graded the difficulty in insertion distribution of the data. Student’s t-test (parametric)
as easy: 1, moderate: 2, difficult: 3 and impossible: 4.[8] and Mann–Whitney U test (non-parametric) were
used to compare the quantitative variables between
A suction catheter was inserted through the gastric the different study groups. The Chi-square test was
tube channel in all cases. The patients were put on employed to compare the categorical data, and when
mechanical ventilation using volume-controlled the expected frequency was <5, the Fisher exact test
ventilation set to deliver a tidal volume of 8 ml/kg, was applied. P value < 0.05 was considered to be
respiratory rate to maintain EtCO2 value between 30 statistically significant. All statistical analyses were
and 40 mmHg, inspiratory and expiratory ratio (1:2) performed using Statistical Package for the Social
and a peak end-expiratory pressure of 5 cm H2O. Total Science (SPSS) version 21 (International Business
fresh gas flow was maintained at 1.5 l/min. Anaesthesia Machines SPSS Inc., Chicago, IL, USA) statistical
was maintained by 4%–6% desflurane in 50:50 oxygen program for Microsoft Windows.
and nitrous oxide. Additional IV 1 µ g/kg fentanyl was
given when clinically needed during anaesthesia. RESULTS
Finally, neuromuscular blockade was reversed with an
IV injection of 0.04 mg/kg neostigmine and 0.001 mg/kg In the present study, 100 patients were recruited;
glycopyrrolate. I-gel was removed after confirming the each completed the study [Figure 1]. Both groups in
recurrence of the spontaneous and regular ventilation the study were compared regarding demographic data
pattern and sustained head lift for at least 5 s. Patients [Table 1].
were shifted to the post-anaesthesia care unit (PACU)
for observation. Both groups had a statistically significant difference
in OLP (P = 0.018). The mean OLP of Group C
Haemodynamic parameters were recorded at 1-min was 30.46 ± 3.76 mmHg and Group R was
intervals from the beginning of the process till the 32.12 ± 3.10 mmHg. Both techniques had a high success
successful placement, once after placement, after the rate on the first attempt (98%). One patient in each group
removal of the device and after shifting the patient to required a second attempt for successful placement. The
the PACU. Blood staining during the removal of i-gel
and dental injury, if any, was noted at the end of the Table 1: Demographic data of the patients
surgery. Postoperatively, patients were followed up for Parameter Group C Group R P
(n=50) (n=50)
up to 12 h for any complaints of sore throat, dysphagia
Male/female 35/15 42/8 0.153
and dysphonia. Numerical Rating Scale (NRS) (0–10) Age (years) 40.56±14.16 38.16±11.77 0.359
was used to rate sore throat by asking the patient Height (cm) 160.94±7.81 159.30±6.33 0.252
verbally about the intensity of throat pain, that is, 0: Weight (kg) 73.64±14.42 71.36±11.64 0.396
no pain, 1–3: mild, 4–6: moderate and 7–10: severe. BMI (kg/m²) 28.39±4.44 28.14±4.05 0.769
NRS of ≥4 was interpreted as a sore throat.[10] Overweight/Obese I/Obese II 16/17/17 13/22/15 0.584
ASA class 1/II/III (number) 22/24/4 26/23/1 0.341
Duration of surgery (min) 51.90±18.62 53.40±24.69 0.732
The sample size was determined based on a
Size of the i-gel inserted
previous study[2], which compared the OLP values 3/4/5 (number) 8/33/9 13/32/5 0.309
in obese versus non-obese patients with i-gel using Data are expressed as mean±SD or number. ASA=American Society of
Anesthesiologists, BMI: body mass index, SD=standard deviation. BMI values:
a conventional technique. The mean OLP reported overweight: 23–24.9 kg/m², obese I: 25–29.9 kg/m², obese II: ≥30 kg/m²
was 27.38 ± 4.38 cmH2O in the obese group. Hence, a (Asian criteria of BMI for nutritional status).[7]

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Ahuja, et al.: Reverse i-gel insertion in obese patients

mean time of insertion in Group C was 16.42 ± 1.86 s, injury, blood staining, dysphagia, dysphonia or sore
and in Group R was 13.98 ± 1.97 s. The difference in throat [Table 2]. The sore throat was graded on NRS;
the mean time of successful i-gel insertion between the even though the result was statistically significant,
groups was statistically significant (P < 0.001). none of the patients experienced sore throat (NRS >4).
The haemodynamic parameters, like heart rate, blood
Withdrawal and advancement were required in five pressure, oxygen saturation and EtCO2, remained
patients in Group C, while they were not needed in stable throughout the procedure [Table 3].
Group R (P = 0.02). Other manipulations required
during the study, like chin lift, jaw thrust, head DISCUSSION
extension and neck flexion, were minimal and
statistically insignificant. None of the patients in Our study found that using the reverse technique
each group had intraoperative or postoperative produced a significantly higher OLP and better
complications like desaturation episodes, dental placement than the conventional technique. We

Enrolment Assessed for eligibility (n = 100)

Excluded (n = 0)
(n = 0)
(n = 0)
(n = 0)

Randomised (n = 100)

Allocation

Allocated to Group C (n = 50) Allocated to Group R (n = 50)


(n = 50) (n = 50)
(n = 0) (n = 0)

Follow-up

Lost to follow-up (n = 0) Lost to follow-up (n = 0)


(n = 0) (n = 0)

Analysis

Analysed (n = 50) Analysed (n = 50)


(n = 0) (n = 0)

Figure 1: Consolidated standards of reporting trials (CONSORT) flow diagram

Table 2: Data comparing study parameters between the groups


Parameter Group C (n=50) Group R (n=50) P
Successful placement at the first attempt (number) 49 49 1.000
OLP (mmHg) 30.46±3.76 (29.39–31.53) 32.12±3.10 (31.24–33.00) 0.018
Time of insertion (s) 16.42±1.86 (15.89–16.95) 13.98±1.97 (13.42–14.54) 0.001
Withdrawal and advancement (number) 5 0 0.022
Chin lift (n) 3 1 0.307
Jaw thrust (n) 0 0 -
Head extension and neck flexion (n) 2 2 1.000
Ease of insertion (n)
Difficult/moderate/easy 1/17/32 1/13/36 0.681
Data are expressed as Mean±SD (95% CI) or number. CI=confidence interval, OLP=oropharyngeal leak pressure, SD=standard deviation

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Ahuja, et al.: Reverse i-gel insertion in obese patients

Table 3: Study data showing haemodynamic parameters Table 3: Contd...


recorded during the study Parameter Group C Group R P
Parameter Group C Group R P 95% CI 98.69–99.19 98.81–99.31
HR Baseline 80.08±13.04 81.54±11.64 0.556 EtCO2 Baseline 31.36±1.55 31.80±1.77 0.189
95% CI 76.37–83.79 78.23–84.85 95% CI 30.92–31.80 31.30–32.30
1 min 80.92±14.09 81.88±12.08 0.715 1 min 31.16±1.72 31.08±1.81 0.821
95% CI 76.92–84.92 78.45–85.31 95% CI 30.67–31.65 30.57–31.59
2 min 80.40±13.93 81.52±12.68 0.675 2 min 31.40±1.46 31.58±1.65 0.565
95% CI 76.44–84.36 77.91–85.13 95% CI 30.99–31.81 31.11–32.05
3 min 80.48±14.83 80.72±12.54 0.931 3 min 31.68±1.57 32.10±1.61 0.189
95% CI 76.26–84.70 77.16–84.28 95% CI 31.23–32.13 31.64–32.56
Placement 80.00±14.88 80.92±14.32 0.753 Placement 32.16±1.56 32.42±1.73 0.431
95% CI 75.77–84.23 76.85–84.99 95% CI 31.72–32.60 31.93–32.91
Removal 84.80±13.73 86.24±12.78 0.588 Removal 31.92±1.68 32.46±1.67 0.110
95% CI 80.90–88.70 82.61–89.87 95% CI 31.44–32.40 31.99–32.93
PACU 82.36±12.54 83.52±10.87 0.622 PACU 31.74±1.52 32.06±1.49 0.291
95% CI 78.80–85.92 80.43–86.61 95% CI 31.31–32.17 31.64–32.48
NIBP SYS Baseline 133.28±14.38 130.08±15.16 0.282 Data are expressed as Mean±SD (95% CI). CI=confidence interval,
95% CI 129.19–137.37 125.77–134.39 EtCO2=end-tidal carbon di-oxide (mmHg), HR=heart rate (per min), NIBP
DIA=diastolic non-invasive blood pressure (mmHg), NIBP SYS=systolic
1 min 129.32±15.48 126.88±17.43 0.461 non-invasive blood pressure (mmHg), SpO2=peripheral oxygen saturation (%),
95% CI 124.92–133.72 121.93–131.83 PACU=post-anaesthesia care unit, SD=standard deviation
2 min 122.84±13.97 120.12±16.10 0.369
95% CI 118.87–126.81 115.54–124.70 observed a high success rate of i-gel insertion in the
3 min 120.84±14.52 116.04±15.83 0.147
first attempt for both techniques.
95% CI 116.35–124.61 111.54–120.54
Placement 118.80±14.38 113.96±14.46 0.097
95% CI 114.71–122.89 109.85–118.07 Kim et al.,[5] who studied the insertion of i-gel by standard
Removal 131.04±16.81 127.32±14.19 0.235 and rotational techniques in non-obese patients,
95% CI 126.26–135.82 123.29–131.35 reported the insertion of i-gel by a non-conventional
PACU 130.16±14.78 126.68±13.42 0.221 technique in a first randomised controlled trial. They
95% CI 125.96–134.36 122.87–130.49
encountered difficulty because tongue folding resulted
NIBP DIA Baseline 81.12±9.31 78.04±8.51 0.087
95% CI 78.47–83.77 75.62–80.46
in the i-gel embedding at the posterior pharynx during
1 min 78.88±8.36 75.64±9.04 0.066 insertion by the conventional technique. Still, they
95% CI 76.50–81.26 73.07–78.21 found higher OLP in the rotational technique than
2 min 74.44±8.95 72.68±10.46 0.368 in the conventional technique. Our study found
95% CI 71.90–76.98 69.71–75.65
higher OLP in the reverse technique than in the
3 min 73.00±9.41 69.56±9.66 0.074
95% CI 70.33–75.67 66.82–72.30
conventional technique. Bhardwaj et al.[6] compared
Placement 72.16±10.58 68.48±10.47 0.084 three techniques, standard, rotational and reverse,
95% CI 69.15–75.17 65.50–71.46 for i-gel. They studied the insertion characteristics,
Removal 77.40±10.03 75.36±8.37 0.272 first-attempt insertion and overall success rate in
95% CI 74.55–80.25 72.98–77.74 non-obese patients. They found that i-gel insertion
PACU 77.28±8.34 75.64±7.38 0.300
with reverse technique resulted in better positioning
95% CI 74.91–79.65 73.54–77.74
SpO2 Baseline 98.38±1.16 98.64±1.08 0.249 in the first attempt and overall success rate along with
95% CI 98.05–98.71 98.33–98.95 higher leak pressures, but the results were statistically
1 min 98.90±0.97 99.20±0.90 0.114 insignificant.
95% CI 98.62–99.18 98.94–99.46
2 min 99.10±0.89 99.32±0.84 0.207 Our study was conducted in overweight and obese
95% CI 98.85–99.35 99.08–99.56
patients, and current literature evidence on using
3 min 99.22±0.82 99.36±0.83 0.396
95% CI 98.99–99.45 99.12–99.60
the reverse technique in obese patients is limited.
Placement 99.28±0.81 99.48±0.68 0.183 Nevertheless, reversing the device prevents tongue
95% CI 99.05–99.51 99.29–99.67 folding and reduces the resistance between i-gel and
Removal 99.04±0.81 99.24±0.87 0.236 the posterior pharyngeal wall. The flexible nature
95% CI 98.81–99.27 98.99–99.49 of its cuff and the laryngeal soft tissue in the airway
PACU 98.94±0.87 99.06±0.89 0.496
helps push the i-gel cuff more effectively. It leads to
Contd... a better seal and higher leak pressures between the

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Ahuja, et al.: Reverse i-gel insertion in obese patients

laryngeal inlet and the i-gel cuff. This could be why However, there was a comparable successful placement
the OLP in this study was significantly higher with the of i-gel at the first attempt with both conventional and
reverse technique. reverse techniques.

The study by Prabha et al.[2] compares i-gel insertion for Study data availability
general anaesthesia in non-obese and obese patients De-identified data may be requested with reasonable
using conventional techniques. The study showed justification from the authors (email to the
higher mean OLP in obese patients than non-obese corresponding author) and shall be shared after
patients (28.7 vs. 25.8 cmH2O). OLP depends upon approval as per the authors’ Institution policy.
the seal between the cuff and perilaryngeal tissues.
The anatomically shaped i-gel is flexible and fits Financial support and sponsorship
comfortably to the perilaryngeal anatomy. The Nil.
thermoelastic material of the cuff expands due to the
body temperature and provides a reliable seal. The
OLP is higher due to excess soft tissue in the oral and There are no conflicts of interest.
pharyngeal cavity. I-gel can be safely used in obese
patients as obesity is no more identified as a risk REFERENCES
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