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Comparative study between I-gel, a new supraglottic airway device, and classical laryngeal mask airway in anesthetized spontaneously ventilated patients

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To compare two different supraglottic airway devices, the laryngeal mask airway (LMA) and the I-gel, regarding easiness of insertion of the device, leak pressure, gastric insufflation, end tidal CO(2), oxygen saturation, hemodynamic and postoperative complications in anesthetized, spontaneously ventilated adult patients performing different non-emergency surgical procedures. The study was carried out as a prospective, randomized, clinical trial among 80 patients who underwent different surgical procedures under general anesthesia with spontaneous ventilation in supine position. They were equally randomized into two groups: I-gel and LMA groups. Both the devices were compared with regard to heart rate, arterial BP, SPO(2), end-tidal CO(2), number and duration of insertion attempts, incidence of gastric insufflation, leak pressure and airway assessment after removal of the device. No statistically significant difference was reported between both the groups, regarding heart rate, arterial BP, SPO(2) and end-tidal CO(2). The mean duration of insertion attempts was 15.6±4.9 seconds in the I-gel group, while it was 26.2±17.7 seconds in the LMA group. The difference between both the groups regarding duration of insertion attempts was statistically significant (P=0.0023*), while the number of insertion attempts was statistically insignificant between both the study groups (P>0.05). Leak pressure was (25.6±4.9 vs. 21.2±7.7 cm H(2)O) significantly higher among studied patients of the I-gel group (P=0.016*) and the incidence of gastric insufflation was significantly more with LMA group 9 (22.5%) vs. I-gel group (5%) (P=0.016). Both LMA and I-gel do not cause any significant alteration in the hemodynamic status of the patients, end tidal CO(2), and SPO(2). The postoperative complications were not significantly different except nusea and vomiting was statistically significant higher in LMA group (P=0.032). among both LMA and I-gel patients. Insertion of I-gel was significantly easier and more rapid than insertion of LMA. Leak pressure was significantly higher with I-gel than LMA and thus incidence of gastric insufflation was significantly lower with I-gel.
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583 M.E.J. ANESTH 21 (4), 2012
COMPARATIVE STUDY BETWEEN I-GEL,
A NEW SUPRAGLOTTIC AIRWAY DEVICE,
AND CLASSICAL LARYNGEAL MASK
AIRWAY IN ANESTHETIZED SPONTANEOUSLY
VENTILATED PATIENTS
Hossam m. atef**, amr m. Helmy*,
ezzat m. el-taHer* and aHmed mosaad Henidak*
Abstract
Objective: To compare two different supraglottic airway devices, the laryngeal mask airway
(LMA) and the I-gel, regarding easiness of insertion of the device, leak pressure, gastric insufation,
end tidal CO2, oxygen saturation, hemodynamic and postoperative complications in anesthetized,
spontaneously ventilated adult patients performing different non-emergency surgical procedures.
Materials and Methods: The study was carried out as a prospective, randomized, clinical trial
among 80 patients who underwent different surgical procedures under general anesthesia with
spontaneous ventilation in supine position. They were equally randomized into two groups: I-gel
and LMA groups. Both the devices were compared with regard to heart rate, arterial BP, SPO2,
end-tidal CO2, number and duration of insertion attempts, incidence of gastric insufation, leak
pressure and airway assessment after removal of the device.
Results: No statistically signicant difference was reported between both the groups,
regarding heart rate, arterial BP, SPO2 and end-tidal CO2. The mean duration of insertion attempts
was 15.6 ± 4.9 seconds in the I-gel group, while it was 26.2 ± 17.7 seconds in the LMA group.
The difference between both the groups regarding duration of insertion attempts was statistically
signicant (P 0.0023*), while the number of insertion attempts was statistically insignicant
between both the study groups (P >0.05). Leak pressure was(25.6 ± 4.9 versus 21.2 ± 7.7 0.016*
cmH2O) signicantly higher among studied patients of the I-gel group and incidence of gastric
insufation was signicantly more with LMA 9 (22.5%) versus 2 (5%) 0.016* in I-gel group.
Conclusion: Both LMA and I-gel do not cause any signicant alteration in the hemodynamic
status of the patients, end tidal CO2, and SPO2. The postoperative complications were not signicantly
different except nusea and vomiting was statistically signicant higher in LMAgroup(P 0 .032).
among both LMA and I-gel patients. Insertion of I-gel was signicantly easier and more rapid than
insertion of LMA. Leak pressure was signicantly higher with I-gel than LMA and thus incidence
of gastric insufation was signicantly lower with I-gel.
Key words: Classical laryngeal mask airway, I-gel, supraglottic airway devices
* Department of Anesthesia and Intensive Care, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.
Corresponding author: Hosam Atef, Department of Anesthesia and Intensive Care, Faculty of Medicine, Suez Canal
University, Ismailia, Egypt, Email: hosamatef375@yahoo.com
584 H. M. ATEF ET AL.
Introduction
The major responsibility of the anesthesiologist
is to provide adequate ventilation to the patient. The
most vital element in providing functional respiration
is the airway. Management of the airway has come
a long way since the development of endotracheal
intubation by Macewen in 1880 to the present day
usage of sophisticated devices1. The tracheal intubation
is the gold standard method for maintaining a patent
airway during anesthesia2. However, this maneuver
requires skill and continuous training and practice and
usually requires direct laryngoscopy, which may cause
laryngopharyngeal lesions3.
Laryngoscopy and endotracheal intubation
produce reex sympathetic stimulation and are
associated with raised levels of plasma catecholamines,
hypertension, tachycardia, myocardial ischemia,
depression of myocardial contractility, ventricular
arrhythmias and intracranial hypertension4. The wide
variety of airway devices available today may broadly
be classied as intraglottic and extraglottic airway
devices, which are employed to protect the airway in
both elective as well as emergency situations5.
The laryngeal mask airway (LMA; Laryngeal
Mask Company, Henley-on-Thames, UK) has been
well established for more than a decade and is often
used when endotracheal intubation is not necessarily
required6. Nevertheless, simple handling of the LMA
is limited by the potential risk of aspiration7 (because
beroptic studies have found 6-9% visualization
of the esophagus via the LMA)8,9 or low pulmonary
compliance [(e.g. obesity) requiring peak inspiratory
pressures greater than 20 cm H2O]10.
I-gel is the single use supraglottic airway from
intersurgical, UK (Intersurgical Ltd, Wokingham,
Berkshire, UK) with an anatomically designed mask
made of a gel like thermoplastic elastomer. It has
features designed to separate the gastrointestinal
and respiratory tracts and allow a gastric tube to be
passed into the stomach4. The tensile properties of the
I-gel bowl, along with its shape and the ridge at its
proximal end, contribute to the stability of the device
upon insertion. Upon sliding beneath the pharyngo-
epiglottic folds, it becomes narrower and longer,
creating an outward force against the tissues. The ridge
at the proximal bowl catches the base of the tongue,
also keeping the device from moving upward out of
position (and the tip from moving out of the upper
esophagus)11.
The main aim of this study was to compare the
I-gel with the LMA in terms of the success of insertion
of the device, gas leak pressure, the incidence of
gastric insufations and postoperative device related
complications.
Materials and Methods
Subjects
This study was carried out as a prospective,
randomized, clinical trial. After getting approval
from our ethics committee, 80 patients aged 21-60
years, of both sexes, who underwent different surgical
procedures under general anesthesia with spontaneous
ventilation in supine position for not more than 2 hours
in routine surgical theaters in Suez Canal University
Hospital in Ismailia city, were enrolled based on
certain inclusion and exclusion criteria. Inclusion
criteria included the following: (i) patients of ASA
I or ASA II and (ii) patients whose body mass index
(BMI) was 20-25 kg/m2. Patients with reported history
of hypersensitivity for one or more of the medications
and latex, patients having any abnormality of the
neck, upper respiratory tract, patients with history of
obstructive sleep apnea or patients who underwent
thoracic, abdominal and neurosurgery operations were
excluded. The patients were equally randomized into
two groups: group 1 (I-gel group) and group 2 (LMA
group).
Methods
Preoperative assessment and medication
Complete medical history and physical
examination were done for all patients, including
assessment of vital signs and airway assessment. After
arrival in the pre-anesthetic area, the patients were given
2 mg midazolam intravenously (IV) as premedication,
and then 10 mg Metoclopramide IV was also given 3
minutes before induction of anesthesia Preoxygenation
for 3minutes, and anesthesia was induced with fentanyl
1mic/kg, and propofol 2mg/kg.
M.E.J. ANESTH 21 (4), 2012
585
COMPARATIVE STUDY BETWEEN I-GEL, A NEW SUPRAGLOTTIC AIRWAY DEVICE, AND CLASSICAL
LARYNGEAL MASK AIRWAY IN ANESTHETIZED SPONTANEOUSLY VENTILATED PATIENTS
Device insertion
After an adequate depth of anesthesia had been
achieved, each device was inserted by the same senior
anesthetist (A H). In group 1, the classical LMA was
inserted according to the manufacturer’s instruction
manual. A size 3 and 4 mask was used in females
and a size 4 and 5 mask in males. The LMA cuff was
inated with 20ml; 30ml; 40ml of air for size 3; 4; 5
respectively as recommended by the manufacture12.
For patients of group 2, the I-gel size #3, 4
or 5 was inserted according to the manufacturer’s
instructions13.
In both the groups, if it was not possible to
ventilate the lungs, the following airway maneuvers
were allowed: chin lift, jaw thrust, head extension, or
exion on the neck. In the case of I-gel, the position
was also allowed to be adjusted by gently pushing or
pulling the device. After any maneuver, adequacy of
ventilation was re-assessed. This maneuver was used
with one patient in LMA group. If it was not possible
to insert the device or ventilate through it, two more
attempts at insertion were allowed. If placements had
failed after three attempts, the case was abandoned and
the airway maintained through other airway device
as suitable and this case was considered as a failed
attempt.
Maintenance of anesthesia
After securing the device, spontaneous ventilation
in oxygen, air and inhalational agent was started.
Ventilation was judged to be optimal if the following
four tests will be passed: (i) adequate chest movement;
(ii) stable oxygenation not less than 95%; (iii) “square
wave” capnography and (iv) normal range end tidal
CO2.
Removal of the device
At the end of the operation, anesthetic agents
were discontinued, allowing smooth recovery of
consciousness. The device was removed after the
patient regained consciousness spontaneously and
responded to verbal command to open the mouth.
Dysphagia, dysphonia, nausea, vomiting and trauma of
mouth, tooth or pharynx, and sore throat were recorded
and reassessed within 24 hours.
Parameters measured
Monitoring equipments (Datex-Ohmeda) were
attached to the patient including 3 leads ECG and non-
invasive blood pressure pulse oximetry and manometer
was connected to the inspiratory limb of the breathing
system to measure the airway pressure. The following
parameters were measured.
1) Heart rate, non-invasive blood pressure, end-
tidal CO2 tension and oxygen saturation (SpO2).
2) The leak pressure by closing the expiratory
valve of the circle system at a xed low gas ow
(3L/min), observing the air-way pressure at which
equilibrium was reached. At this point, gas leakage
was heard at the mouth, at the epigastrium (epigastric
auscultation) or coming out the drainage tube (I-gel
group). manometric stability test is one of the most
reliable test14.
3) Number of insertion attempts and each attempt
duration (time from picking up the device until
attaching it to the breathing system in minutes).
4) Incidence of airway complications caused by
supraglottic devices.
= reporting of post-extubation cough, breath holding
or laryngeal spasm,
= observing presence of blood on the I-gel or LMA,
and
= lip and dental injury.
Each patient
was questioned to determine the
following complications (in recovery room and 24
hours postoperatively): sore
throat (constant pain,
independent of swallowing), dysphagia
(difculty or
pain with swallowing), sore jaw, dysphonia (difculty
or pain with speaking), numbness of the tongue or the
oropharynx,
blocked or painful ears, reduced hearing,
or neck pain. Primary outcome measures: number
and duration of insertion attempts,sealing pressure
and peak airway pressure. Secondary outcome
measures: postoperative airway complications.
Power analysis was based on Duration of insertion
attempts (sec.) with Standard deviation (s) 15.62 and
Variance (s
2
) 243.9.considering alpha (z
α
) error (p =
0.05; therefore, 95% condence desired (two-tailed
586 H. M. ATEF ET AL.
test); z
α
= 1.96) and beta (z
β
) error (20% beta error,
therefore, 80% power desired (one-tailed test); z
β
=
0.84). Difference to be detected (d) 10 sec. Or larger
difference between mean duration of the experimental
group and control group 39 patients were required in
each group.
Statistical Analysis
The Data was collected and entered into the
personal computer. Statistical analysis was done using
Statistical Package for Social Sciences (SPSS/version
17) software. A comparison of the overall abilities of
the two techniques to accurately classify the patients
was performed by a Z test to compare two portions.
Arthematic mean, standard deviation, number and
percent was calculated for each parameter. For
categorized parameters chi-square test was used, Fisher
exact test was used for data less than 5 in each cell,
while for numerical data t-test was used to compare
two groups. The level of signicant was 0.0515.
Results
Analysis of the demographic characteristics of
our patients under study has revealed that there was
no statistically signicant difference when comparing
the mean age between the two groups (P >0.05). The
same was found regarding the distribution of sex, as
no statistically signicant difference was found when
comparing the two groups. Most of the patients in the
groups of the study were found to be males (60 and 70%
in I-gel and LMA groups, respectively). There was no
statistically signicant difference found in BMI between
the two groups of the study (P >0.05) (Table 1).
Table 1
Personal characteristics of the patients under study
Characteristic I-gel group
(n = 40)
LMA group
(n = 40)
Age 38.29 ± 12.4 41.62 ± 13.4
Gender Male 24 (60%) 28 (70%)
Female 16 (40%) 12 (30%)
BMI (kg/m2) 23.13 ± 2.15 22.91 ± 4.03
Data are presented as mean ± SD or numbers (percentages)
NS: no statistically signicant difference (P >0.05)
No statistically signicant difference was found
between both groups of the study, regarding each of
systolic BP, diastolic BP, heart rate, SPO2 (%) and end-
tidal CO2 throughout the whole duration of the surgery.
Table 2 shows that insertion and ventilation was
possible at the rst attempt in 90% of patients in the
I-gel group and in 80% in LMA group. In 5% of the
patients in LMA group, intubation and ventilation was
possible after the third attempt. The mean duration of
insertion attempts was 15.62 ± 4.9 seconds in I-gel
group, while it was 26.2 ± 17.7 seconds in LMA group.
The difference between both groups regarding duration
of insertion attempts was statistically signicant (P
0.0023), while the number of insertion attempts was
statistically insignicant between both the study
groups (P >0.05). Leak pressure was signicantly
higher among patients of the I-gel group (25.62 ± 4.9
Table 2
Comparison between I-gel and LMA groups with respect to different parameters
Parameter I-gel group (n = 40) LMA group (n = 40) P value
Number of insertion attempts One attempt 36 (90%) 32 (80%)
0.45 (NS)
Two attempts 3 (7.5%) 6 (15%)
Three attempts 1 (2.5%) 2 (5%)
Duration of insertion attempts (seconds) 15.62 ± 4.9 26.2 ± 17.7 0.0023*
Leak pressure (cm H2O) 25.62 ± 4.9 21.2 ± 7.7 0.016*
Incidence of gastric insufation 2 (5%) 9 (22.5%) 0.016*
Data are presented as mean ± SD or numbers (percentages)
NS: no statistically signicant difference (P >0.05)
*Statistically signicant difference (P <0.05)
M.E.J. ANESTH 21 (4), 2012
587
COMPARATIVE STUDY BETWEEN I-GEL, A NEW SUPRAGLOTTIC AIRWAY DEVICE, AND CLASSICAL
LARYNGEAL MASK AIRWAY IN ANESTHETIZED SPONTANEOUSLY VENTILATED PATIENTS
versus 21.2 ± 7.7 cm H2O in LMA group; P <0.016).
The incidence of gastric insufation was signicantly
more with LMA (22.5% versus 5% in I-gel group; P
<0.016).
No statistically signicant difference was found
between both I-gel and LMA groups with regard to
the assessment of patients after removal of the airway
device (Table 3).
Success rate of gastric tube insertion was
estimated to be 95%. Failed insertion was reported
only among two patients (5%) (Table 4).
Table 4
Success rate of gastric tube insertion among the patients of
I-gel group
Number Percent
Gastric tube insertion
Success 38 95
Failure 2 5
Total 40 100
Discussion
The I-gel is a new supraglottic device, without an
inatable cuff, designed for use during anaesthesia11.
It is a latex free, disposable device, made of a medical
grade thermoplastic elastomer. I-gel is anatomically
preformed to mirror the perilaryngeal structures. The
device contains an epiglottis blocker, which helps to
prevent epiglottis from downfolding or obstructing
laryngeal inlet. The soft non-inatable cuff seals
anatomically against perilaryngeal structures.
Furthermore, the I-gel has a gastric channel allowing
venting of the air and gastric contents or insertion of
gastric tube16.
It has features designed to separate the
gastrointestinal and respiratory tracts and allow a
gastric tube to be passed into the stomach. Early
reports have postulated its use as a potential airway for
use in resuscitation17. Many studies compared LMA
with I-gel18-20.
Regarding the hemodynamic stability and effect
of each of the supraglottic devices, no statistically
signicant difference was reported when comparing
heart rate, systolic and diastolic arterial blood pressure
throughout the surgery. Jindal et al.21 reported
hemodynamic stability with both LMA and I-gel
devices, with no statistically signicant difference
between both devices, which is consistent with our
ndings.
Richez et al.13 carried out one of the earliest
Table 3
Assessment of patients after device removal among the patients in both groups of the study
I-gel group (n = 40) LMA group (n = 40) P value
Presence of blood on airway device 2 (5%) 4 (10%) 0.46 (NS)
Lip or dental injury 1 (2.5%) 2 (5%) 0.69 (NS)
Post removal cough 2 (5%) 6 (15%) 0.6 (NS)
Laryngeal spasm 4 (10%) 4 (10%) 1 (NS)
Sore throat Mild 12 (32.5%) 10 (25%) 0.34 (NS)
Moderate 3 (7.5%) 5 (12.5%)
Dysphagia, dysphonia 2 (5%) 2 (5%) 1 (NS)
Postoperative nausea or vomiting 2 (5%) 8 (20%) 0.032*
Arrhythmia 2 (5%) 3 (7.5%) 0.69 (NS)
Pain on swallowing Mild 21 (52.5%) 26 (65%) 0.47 (NS)
Moderate 4 (10%) 8 (20%)
Ear pain 3 (7.5%) 5 (12.5%) 0.46 (NS)
Hearing change 1 (2.5%) 2 (5%) 0.69 (NS)
NS: no statistically signicant difference (P > 0.05)
588 H. M. ATEF ET AL.
studies to evaluate the I-gel. They found that insertion
success rate was 97%. Insertion was easy and was
performed at the rst attempt in every patient. I-gel
is easily and rapidly inserted, providing a reliable
airway in over 90% of cases. Acott22. assessed the
use of I-gel as an airway device during general
anesthesia. In accordance with our results, they
reported that a single insertion attempt was required
in the majority of patients and all the insertion times
recorded were less than 10 seconds. Similar results
were obtained in study done by Gatward et al.23, who
evaluated size 4 I-gel airway in 100 non-paralyzed
patients and found that rst insertion attempt was
successful in 86% of patients, the second attempt
in 11% of patients and the third attempt in 3% of
patients.
Levitan and Kinkle11 studied the positioning and
mechanics of this new device in 65 non-embalmed
cadavers with 73 endoscopies (eight had repeat
insertion), 16 neck dissections, and 6 neck radiographs.
A full view of the glottis (percentage of glottic opening
score 100%) occurred in 44/73 insertions, whereas only
3/73 insertions had epiglottis-only views. Including the
eight repeat insertions with a different size, a glottic
opening score of >50% was obtained in all 65 cadavers.
The mean percentage of glottic opening score for the
73 insertions was 82% (95% condence interval 75-
89%). In each of the neck dissections and radiographs,
the bowl of the device covered the laryngeal inlet.
They found that the I-gel effectively conformed to the
perilaryngeal anatomy despite the lack of an inatable
cuff and it consistently achieved proper positioning for
supraglottic ventilation.
The I-gel has potential advantages over other
supraglottic airways for use by non-anesthetists
during cardiopulmonary resuscitation. It has no cuff to
inate, making it simple to use. Its drain tube allows
access to the gastrointestinal tract and it is designed to
reduce the risk of gastric ination and regurgitation.
Simple airway maneuvers were required to assist in
the placement but all devices were placed within two
attempts24. These ndings are consistent with our
results.
One of the most important parameters to be
compared between both supraglottic devices was
postoperative complications. It was estimated
that difference between LMA and I-gel regarding
postoperative complications was not statistically
signicant except nausea and vomiting which was
signicantly higher in LMA due to high incidence of
gastric insufation. Consistent with our results, no
major complications associated with I-gel have been
described to date. Protection against aspiration is
probably comparable with LMA family (but certainly
not 100%). Minor complications reported include
sore throat, temporary hoarseness, sore tongue,
hyperesthesia of tongue13.
In the present study, only in two patients of the
I-gel group, blood was on the device after removal.
Acott22, did not report any case of blood on airway
device (I-gel). In accordance with our results, he found
that airway trauma during insertion of the I-gel was
minimal.
Leak pressure was found to be signicantly
higher among patients of I-gel group than in LMA
group (25.62 versus 21.2 cm H2O, respectively). This
denotes that I-gel has better sealing pressure and that
it ts well with the anatomy of supraglottic region.
Acott22 reported a leak pressure greater than 20 cm
H2O in all patients.
Assessment of success rate of gastric tube
insertion with I-gel was found to be 95%. This is
consistent with what has been reported by Richez
et al.13, as the gastric tube was inserted in 100% of
cases. This helps in preventing gastric insufation and
decreasing air leak and thus decreasing postoperative
nausea and vomiting.
A potential risk of the LMA is an incomplete mask
seal, causing gastric insufation or oropharyngeal air
leakage25. Inconsistent with our ndings; Schmidbauer
and colleagues26 concluded that both the ProSeal
LMA and classical LMA provided better seal of the
esophagus than the novel I-gel airway. Consistent with
our results, Weiler et al.6 had reported high incidence
of gastric insufation with the use of LMA.
There are some limitations of the present study.
Firstly, we studied only low risk patients (ASA I and
II) who had normal airways and were mostly not obese.
Secondly, we did not compare performance with the
likely competitors of the I-gel such as ProSeal LMA
and laryngeal tube.
M.E.J. ANESTH 21 (4), 2012
589
COMPARATIVE STUDY BETWEEN I-GEL, A NEW SUPRAGLOTTIC AIRWAY DEVICE, AND CLASSICAL
LARYNGEAL MASK AIRWAY IN ANESTHETIZED SPONTANEOUSLY VENTILATED PATIENTS
In conclusion, both LMA and I-gel do not
cause any signicant alteration in the hemodynamic
status of the patients, end tidal CO2, and SPO2. The
postoperative complications are not signicantly
different among both LMA and I-gel patients. Insertion
of I-gel is signicantly easier and more rapid than
insertion of LMA. Leak pressure is signicantly higher
with I-gel than with LMA and thus incidence of gastric
insufation is signicantly lower with I-gel.
590
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through an I-gel supraglottic airway in two patients with predicted
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... seconds in the LMA Classic group, a difference that was statistically significant (P = 0.0001). Helmy et al. [13] further corroborated these findings, showing that the I-Gel was associated with a significantly shorter duration of insertion attempts. The study reported a mean duration of insertion attempts of 15.6±4.9 ...
... This feature makes the I-Gel particularly suitable for cases where maintaining a robust and reliable airway is critical, thus supporting its preferred use in various medical and emergency scenarios. A study by Helmy et al. [13] showed that airway sealing pressure was (25.6±4.9 vs. 21.2±7.7 The incidence of adverse effects in the postoperative period among both the groups was statistically significant. ...
... [14] found that I-gel had a significantly higher overall and first attempt success rate of device placement compared to C-LMA, where more patients complained of pharynxgo-laryngeal pain with the LMA Supreme than with the igel (17/39 (44%) vs 8/41 (20%); p = 0.053). A study by Helmy et al. [13] showed that incidence of gastric insufflations was significantly more with LMA group 9 (22.5%) vs. I-gel group (5%) (P=0.016). Overall, the low complication profile associated with the I-Gel underscores its potential benefits over the C-LMA in terms of patient comfort and safety. ...
Article
Objectives: This study aimed to compare the efficacy and safety profile of two supraglottic airway devices, the I-Gel and the Laryngeal Mask Airway Classic (C-LMA) in the patients undergoing general anesthesia for elective lower abdominal and lower limb surgeries. Methods: A total of 60 surgical patients aged 50-70 years, with ASA grade I and II, were enrolled and divided into two groups: the I-Gel group (n=30) and the C-LMA group (n=30). Demographic characteristics, insertion characteristics, hemodynamic stability, airway sealing pressure, and complications were compared between the two groups. Results: Demographic characteristics, including age, weight, gender distribution, ASA grade, and type of surgery, was comparable between the I-Gel and C-LMA groups. In a comparative study between I-Gel and C-LMA groups, the I-Gel demonstrated a significantly faster mean insertion time of 10.0± 3.4 seconds as compared to 18.8± 3.2 seconds for the C-LMA group (t=3.58, p=0.032). Ease of insertion was higher in the I-Gel group with 96.6% reporting easy insertion versus 66.66% in the C-LMA group. Additionally, the I-Gel achieved better airway sealing pressure (24.4 cmH2O vs. 19.2 cmH2O, p=0.023) and had significantly fewer complications like sore throat and hoarseness. Conclusion: The study suggests that the I-Gel device outperforms the C-LMA in various aspects of airway management, including shorter insertion times, better hemodynamic stability, superior airway sealing pressure, and fewer postoperative complications. Key words: Supraglottic airway devices, I-Gel, Laryngeal Mask Airway Classic (C-LMA), airway sealing pressures.
... Changing to an I-gel from a laryngeal mask airway was signicantly faster and less complicated. When compared to the laryngeal mask airway, the I-gel airway exhibited a signicantly higher leak pressure, resulting in a 41 much lower rate of stomach insufation. ...
... When compared to inserting a laryngeal mask airway, inserting an I-gel was far simpler and took much less time. The I-gel airway had a substantially higher leak pressure than the laryngeal mask airway, and as a result, the incidence 41 of stomach insufation was signicantly lower with the I-gel airway. , when the I-Gel is compared with the Cobra-PLA which is a rst generation LMA. ...
Article
Supraglottic airway devices are considered an alternative option in patients undergoing short surgery whose duration is anticipated less than 30mins , in these patients conventional airway management with endotracheal intubation can be avoided , there are several supraglottic airway devices available for use , Cobra-PLA and I-gel are such devices which can be employed for airway management , out study compares these two airway devices in terms of the ease of insertion , time of insertion , hemodynamic changes which occur upon its insertion , adequacy of ventilation and oxygenation and incidence of post-operative complications. Cobra-PLA a cuffed peri pharyngeal sealer which is a rst-generation SGA , resembling the hood of a cobra has been compared with other second generation SGA. The I-gel LMA which is a newly introduced cufess second generation LMA has been compared with other rst generation SGA , however there are few studies which compare the Cobra-PLA with the I-gel LMA.
... Our results of hemodynamic parameters were in concordance with those reported by Amr Helmy et al. and W. H. L. Teoh et al [6][7][8] . ...
... 24 hours later the same patient had throat discomfort in Supreme LMA group where as in the I-Gel group there was NO throat discomfort. Teoh et al. and Ragazzi et al. also found that the use of Supreme LMA produces more sore throat as compared to the I-Gel [5][6][7]13,18,19 . The lower incidence of sore throat in our study can be attributed to the soft seal non inflatable mask of I-GEL. ...
Article
Background and Aims: The objective of this prospective, randomized trial was to compare I-Gel with Supreme LMA in anaesthetized spontaneously breathing patients for short surgical procedures. Material and Methods: Sixty patients of ASAI -ASAII of either gender between 18-60 years undergoing short surgical procedures were randomly assigned to I-gel (Group I) or LMA-Supreme (Group S). After induction with propofol the supraglottic airway device was inserted. We compared the ease and time required for insertion, airway sealing pressure and adverse events related to airway. Results: There were no significant differences in demographic and haemodynamic data. I-gel insertion was easier than LMA Supreme but statistically not significant (p > 0.05) (Chi square test). Numbers of attempts for successful insertions were comparable and in majority device was inserted in first attempt. Although the airway sealing pressure was significantly higher with Group S (25.73+2.21 cm of H2O), the airway sealing pressure of Group I (20.0+2.94 cm of H2O) was very well within normal limit (Student's t test). There was no evidence of airway trauma, regurgitation and aspiration. Conclusion: I-Gel with acceptable limits airway sealing pressure, easier to insert, less traumatic with lower incidence of sore throat. Hence I-Gel can be a good alternative to LMA-Supreme.
... Shin et al., 13 study also showed that there was no difference in the hemodynamic characteristics between the two SADs. The hemodynamic parameters between the two groups were in accordance with studies conducted by Govardhane et al., 14 Helmy et al., 15 and Teoh et al. 3 The success rate in first attempt was comparable between two groups. The success rate of insertion in first attempt in group S (LMA-S) was 85% as compared to 80% in group I (I-gel). ...
Article
Full-text available
Background: Supreme laryngeal mask airway (SLMA) and i-gel airway devices are second generation supraglottic airway devices (SAD) and are good alternatives to intubation during elective surgeries. Aims and Objectives: This study was conducted with the objective of comparing the two SAD with respect to ease of insertion, number of attempts of insertion, insertion time, ease of gastric tube insertion, accompanying hemodynamic changes, incidence of adverse effects like regurgitation, lip and dental trauma, post-operative sore throat, dysphagia, and hoarseness. Materials and Methods: This study was conducted at M.G.M. Medical College and M.Y. hospital, Indore. Eighty patients belonging to ASA class 1 or 2, with Mallampati grading 1 or 2, between age group of 18–60 years and with BMI <30 kg/m2 were selected for the study. After induction of anesthesia, one of the SAD’s (SLMA or i-gel) was inserted following randomization, and accordingly, the patients were divided into two groups of 40 each. Insertion parameters, hemodynamic, and respiratory parameters were noted. Patients were also observed for any possible complication at 1 h and 24 h postoperatively. Results: The Two groups showed no statistically significant difference in terms of demographic characteristics, insertion parameters, hemodynamic, or respiratory parameters (P>0.05). Postoperatively, no significant complications were observed in terms of dental injury, laryngospasm. Ease of gastric tube insertion was found to be more in SLMA group than i-gel and the difference was statistically significant (P=0.0057). Incidence of sore throat after 1 h was found to be more in SLMA group than i-gel group (P=0.048). Conclusion: There was no significant difference between SLMA and i-gel in terms of insertion characteristics and hemodynamic changes. Ease of gastric tube insertion was found to be significantly more in SLMA group than i-gel. Incidence of post-operative sore throat at 1 h was more with SLMA as compared to i-gel.
... Being free of tongue root stimulation is thought to reduce the cardiovascular response caused by tracheal intubation [10]. As Helmy et al., [11] Reza Hashemian et al., [12] and Chauhan et al. [13] observed significantly lower insertion times with i-gel™. Because the i-gel™ doesn't require cuff inflation, the time to establish an effective ~ 118 ~ airway was shorter, and since it doesn't need an introducer, the device can be simply pushed into place [14,15] . ...
... p=0.27). Helmy et al. 12 and Chauhan et al. 13 reported much shorter insertion times with ISA. Because ISA does not require cuff inflation, it takes lesser time to produce a good airway and does not require an introducer. ...
Article
Full-text available
Objective: To compare I-gel Supraglottic Airway with ProSeal-Laryngeal Mask Airway in anaesthetized paralyzed patients regarding mean insertion time and frequency of ease of insertion. Study design: Quasi-experimental study. Place and Duration of Study: Department of Anesthesiology, Combined Military Hospital, Multan Pakistan, from Jun to Dec 2018. Methodology: Ninety-two patients aged 20-50 years, of either gender undergoing procedures in supine and lithotomy positions under general anaesthesia were included. In Group-A, ProSeal-Laryngeal Mask Airway was inserted, and in GroupB, the anaesthetists inserted I-gel Supraglottic Airway. Insertion time and ease of insertion in terms of successful insertion on the first attempt were noted. Results: Out of these 92 patients, 54(58.7%) were male, and 38(41.3%) were female. The median insertion time was 22 seconds with an interquartile range (Q3-Q1) of 17.53 in Group-A patients and 14 seconds in Group-B patients with an interquartile range of 3(p<0.001). The first attempt for placement was successful in 35(76.1%) patients in Group-A and 43(93.5%) patients in Group-B (p=0.039). Conclusion: I-gel Supraglottic Airway has a shorter insertion time and a higher frequency of ease of insertion as compared to the ProSeal-Laryngeal Mask Airway in patients undergoing surgery under general anaesthesia.
... Radhika và cộng sự [4] cho rằng những biến đổi huyết động là do sự thay đổi đáp ứng giao cảm tối thiểu khi bơm căng bóng chèn ở nhóm mặt nạ cổ điển. Nghiên cứu của chúng tôi cũng không gặp tình trạng suy giảm độ bão hòa oxy máu (< 95%) ở cả 2 nhóm trong suốt quá trình đặt mặt nạ, gây mê và sau khi rút; tương tự kết luận của Helmy [5]. ...
Article
Mục tiêu: Đánh giá thuận lợi và các biến đổi huyết động trên các bệnh nhân gây mê tổng quát khi sử dụng mặt nạ thanh quản I-gel và mặt nạ thanh quản cổ điển. Đối tượng và phương pháp: Nghiên cứu thử nghiệm lâm sàng trên hai nhóm bệnh nhân có chỉ định và được gây mê tổng quát thực hiện phẫu thuật theo chương trình (nhóm 1: gồm 50 bệnh nhân đặt mặt nạ thanh quản cổ điển; nhóm 2 gồm 50 bệnh nhân đặt mặt nạ thanh quản I-gel), tại Bệnh viện Quân y 7B, từ tháng 3/2022 đến tháng 7/2022. Kết quả: Không có sự khác biệt về tuổi, giới tính, BMI, tình trạng sức khỏe theo phân độ Mallampatti, ASA giữa hai nhóm bệnh nhân nghiên cứu. Tỉ lệ thành công trong lần đặt đầu tiên với mặt nạ thanh quản I-gel (86,0%) cao hơn so với mặt nạ thanh quản cổ điển (84,0%), nhưng khác biệt không có ý nghĩa thống kê. Thời gian trung bình đặt mặt nạ thanh quản cổ điển (36,06 ± 5,12 giây) dài hơn so với đặt mặt nạ thanh quản I-gel (25,92 ± 3,62 giây), khác biệt với p = 0,0001. Nhóm đặt mặt nạ thanh quản I-gel có sự biến đổi nhịp tim, huyết áp tâm thu, huyết áp tâm trương tại các thời điểm khảo sát thấp hơn so với nhóm đặt mặt nạ thanh quản cổ điển, khác biệt có ý nghĩa thống kê (với p = 0,0001). Kết luận: Mặt nạ thanh quản I-gel có thể thay thế cho mặt nạ thanh quản cổ điển trong gây mê tổng quát cho phẫu thuật.
Article
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Introduction: Igel and LMAC are most commonly used supraglottic air way devices to secure the airway during general anaesthesia our main objectives were to compare the ease of insertion, duration of insertion and number of attempts of insertion between Igel group and LMAC group. Methodology: Prospective randomized study conducted in SVMCH & RC Puducherry, during the period Oct 2015 to Mar 2017. Total patients 120 were divided into two groups LMAC, n = 60 and Igel, n = 60 by randomized method. SPSS 23 Version software was applied for t test as mean±SD for continuous variables and chisquare test used for categorical variables. Results: Igel was more easily inserted then LMAC group (90%, 85%) respectively and was statistically nonsignificant (p>0.05). Duration of insertion was shorter in Igel group compared to LMAC group (9.7±1.02 Vs 17.2±1.99) respectively and statistically highly significant (p<0.001). First attempt success rate was (95% Vs 91.6%) between Igel and LMA C group. Number of insertion attempts between these groups were statistically non significant (p>0.05). Conclusions: Duration of insertion of highly shorter in Igel group. Ease of insertion and first attempt success rate makes and Igel a suitable alternative for elective surgeries under general anaesthesia.
Article
Background and Aims: Supraglottic airway devices have time and again proved that they are a safe and efcient alternative to endotracheal tube in general anaesthetic procedures lasting for a short time even in the paediatric population. The aim of our study was to compare the efcacy of the well-known i-Gel and the newer Blockbuster LMA in anesthetized paediatric patients. Material and Methods:Eighty paediatric patients who received general anaesthesia for less than 120 minutes were randomly divided into two groups of 40 patients each. In one group, Blockbuster LMA (BLMA group) was inserted and in the other group i-GEL ( i-GEL group) was inserted. Standard anaesthesia protocol was followed and the supraglottic airway device was inserted. We compared the time needed for insertion, ease of insertion and airway sealing pressure. Results: There were no signicant differences in demographic data. However, the ease of insertion was better in the BLMA group. The mean insertion time was 1.08 minutes ± 0.59 in the Blockbuster LMA group while it was 2.63 minutes ± 1.27 in the i-Gel group ,p value being <0.0001. Similarly, in the BLMA group, most of the patients had the device inserted successfully without any additional maneuvers.The p value being st <0.0001. In 88% of the patients of the BLMA group, airway was secured in the 1 attempt where as in 47% of the patients in the i-GEL group, airway st was secured in the 1 attempt. p value is 0.001. But, the oropharyngeal leak pressure(OLP) was found to be higher in the i-GEL group, Mean values being 30.10 ± 4.96 cm of H 0 in the i-GEL group compared to 21.20 ± 2.46 cm of H 0 in the BLMA. Block Conclusion: buster LMA is good alternative to i-GEL as an airway device for short surgeries in the paediatric populations.
Article
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Introduction Airway management is one of the most important skills in the field of anaesthesiology, and inability to secure the airway can lead to catastrophic results. Before 1990, only the face mask and the endotracheal tube (ETT) were the available airway devices. Since then several supraglottic airway devices have been developed, of which the laryngeal mask airway (LMA) is the most popular one. 1,2 Laryngeal Mask Airway -Classic The LMA was conceived and designed by Dr. Archie Brain in U.K. in 1981. Following prolonged research, it was released in1988. 1 At an early stage in its development, the inventor realized its potential in the management of the difficult airway. 1,3-6 Today, it has a clearly established role as an airway device in the elective setting where neither the procedure nor the patient requires tracheal intubation. It has now become an established part of routine airway management and has proved extremely useful in managing the difficult airway. Concept and design 1,4,7,8 The LMA fills a niche between the face mask (FM) and tracheal tube (TT) in terms of both anatomical position and degree of invasiveness. It is manufactured from medical grade silicone rubber and is reusable. It consists of 3 main components (fig. 1) : An airway tube, inflatable mask and mask inflation line. The airway tube is slightly curved to match the oropharyngeal anatomy, semirigid to facilitate atraumatic insertion and semitransparent, so that condensation and regurgitated material is visible. A black line runs longitudinally along its posterior curvature to aid in orientation. The distal aperture of the airway tube opens into the lumen of an inflatable mask and is protected by two flexible vertical rubber bars, called mask aperture bars (MAB), to prevent the epiglottis from entering and obstructing the airway. The inflatable mask is oval shaped with a broad, round proximal end and a narrower, more pointed distal end. It has an inflatable cuff and a semirigid, concave, shield like backplate. The cuff is attached to the outer rim of the backplate.
Article
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The i-gel differs from other supraglottic airway devices, in that it has a softer, non-inflatable cuff. This study was designed to compare the performance of the i-gel and the LMA-Unique (LMA-U) when used during anaesthesia in paralysed patients. Both devices were studied in 39 anaesthetized, paralysed patients in a randomized crossover trial. The primary outcome was airway leak pressure. Secondary outcomes included time to insertion, the number of insertion and reposition attempts, leak volumes, and leak fractions. There was no significant difference between the airway leak pressures of the two devices [median (IQR) leak pressures 25 (22-30) vs 22 (20-28) cm H(2)O for the i-gel and LMA-U, respectively; P=0.083, 95% CI of the mean difference -0.32 to 4.88 cm H(2)O]. The median (IQR) insertion time for the i-gel was significantly less than for the LMA-U [12.2 (9.7-14.3) vs 15.2 (13.2-17.3) s; P=0.007]. All the LMA-U devices and 38 of 39 i-gel airways were inserted at the first attempt. The number of manipulations required after insertion to achieve a clear airway was the same in both the groups (four in each). There were no statistically significant differences in leak volumes or leak fractions during controlled ventilation. We found no difference in leak pressures and success rate of first-time insertion between the i-gel and the LMA-U. Time to successful insertion was significantly shorter for the i-gel. We conclude that the i-gel provides a reasonable alternative to the LMA-U for controlled ventilation during anaesthesia.
Article
Resuscitation or airway control of an unconscious diver in a diving bell (DB) or deck decompression chamber (DDC) is difficult. Although the laryngeal mask airway (cLMA) has been recommended by the Diving Medical Advisory Committee, it is associated with many problems in a DB or DDC because of its cuff. A new cuffless airway device, the Intersurgical i-gel™, has been released. This small study showed that diver medical technicians (DMTs) preferred the i-gel to the cLMA because it lacked a cuff and was easier to insert from any position. The i-gel is therefore recommended for use in resuscitation in a DB or DDC.
Article
This study assessed two disposable devices; the newly developed supraglottic airway device i-gel and the LMA-Unique in routine clinical practice. Eighty patients (ASA 1-3) undergoing minor routine gynaecologic surgery were randomly allocated to have an i-gel (n = 40) or LMA-Unique (n = 40) inserted. Oxygen saturation, end-tidal carbon dioxide, tidal volume and peak airway pressure were recorded, as well as time of insertion, airway leak pressure, postoperative sore-throat, dysphonia and dysphagia for each device. Time of insertion was comparable with the i-gel and LMA-Unique. There was no failure in the i-gel group and one failure in the LMA-Unique group. Ventilation and oxygenation were similar between devices. Mean airway pressure was comparable with both devices, whereas airway leak pressure was significantly higher (p < 0.0001) in the i-gel group (mean 29 cmH(2)O, range 24-40) compared with the LMA-Unique group (mean 18 cmH(2)O, range 6-30). Fibreoptic score of the position of the devices was significantly better in the i-gel group. Post-operative sore-throat and dysphagia were comparable with both devices. Both devices appeared to be simple alternatives to secure the airway. Significantly higher airway leak pressure suggests that the i-gel may be advantageous in this respect.
Article
In a randomised cross-over study, we compared the performance of the single use i-gel supraglottic airway and reusable classic laryngeal mask airway (cLMA) in 50 healthy anaesthetised patients who were breathing spontaneously. Primary outcome was successful insertion at first attempt. Secondary outcomes included overall insertion success rate, ease of insertion, leak pressure and fibreoptic position. Success rate for insertion at the first attempt was significantly different (54% with i-gel vs 86% with cLMA; p = 0.001). Overall success after two attempts (when the anaesthetist was allowed to change the size of the device) improved to 84% with i-gel vs 92% with cLMA; p = 0.22. In 14 patients, the i-gel when used first needed to be replaced with a larger size. Leak pressure was higher for the i-gel (median [IQR] 20 [14-24] cm H(2)O than the cLMA 17 [12-22] cm H(2)O; p = 0.023). The fibreoptic view through the device was significantly better with the i-gel than the cLMA, which was statistically significant (p = 0.03). We conclude that, with its current sizing recommendations, the i-gel is not an acceptable alternative to cLMA. However because of the significantly improved success rate after a larger sized i-gel was used, we recommend the manufacturer to review the sizing guidelines to improve the success rate.