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International Journal of Research in Medical Sciences | November 2022 | Vol 10 | Issue 11 Page 2549
International Journal of Research in Medical Sciences
Ashraf N et al. Int J Res Med Sci. 2022 Nov;10(11):2549-2554
www.msjonline.org
pISSN 2320-6071 | eISSN 2320-6012
Original Research Article
Comparative study of Igel with proseal LMA for ease of insertion and
effect on hemodynamics in pediatric patients
Nashrah Ashraf1, Owais-ul-umer Zargar2*, Ayat Albina3, Ayaz Farooqi1
INTRODUCTION
Airway management is one of the most important skills
in the field of anaesthesiology. The anaesthesiologist
must ensure a patent airway and adequate ventilation.
Endotracheal intubation is being considered as the gold
standard technique till date. However, it has certain
disadvantages like exaggerated hemodynamic response,
airway morbidity, dental trauma, barotraumas, coughing
and bucking usually during emergence from anesthesia,
etc.1 Furthermore, in pediatric patients, due to anatomical
reasons (large omega shaped epiglottis, higher and more
anterior situation of glottis) and physiological reasons
(reduced functional residual capacity (FRC) and higher
oxygen requirement) intubation may be difficult and
chances of hypoxia increase.2
The laryngeal mask airway (LMA) is a supraglottic
airway device (SAD) designed to maintain a patent
1Department of Anesthesiology and Critical care, Sher-i-Kashmir Institute of Medical Science, Srinagar, Jammu and
Kashmir, India
2Department of Surgery, 3Department of Obstetrics and Gynecology, Government Medical College and Hospital,
Jammu, Jammu and Kashmir, India
Received: 10 September 2022
Revised: 04 October 2022
Accepted: 10 October 2022
*Correspondence:
Dr. Owais-ul-umer Zargar,
E-mail: drowais111@gmail.com
Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.
ABSTRACT
Background: Supraglottic airway devices offer several advantages over endotracheal tube with regards to ease of
insertion, hemodynamic stability, decreased airway morbidity, reduced requirement of drugs and smoother emergence
from anesthesia. Objective was to compare two supraglottic airway devices, Igel and proseal LMA, with respect to
ease of insertion, number of insertion attempts, time taken for placement of device and hemodynamic changes.
Methods: This prospective, randomized observational study was conducted in a tertiary care hospital in India after
obtaining approval from the ethical committee of the institute. Sample size consisted of 80 patients who were
randomized into two groups with each group having 40 patients.
Results: In our study it was found that Igel was easier to insert in 95% of the patients as compared to proseal
laryngeal mask airway, whose insertion was found easy in 77.5% of the patients. There was higher success rate in first
attempt insertion for Igel as compared to proseal laryngeal mask airway. 95% of the patients had successful device
insertion in single attempt in group Igel and 77.5% of the patients had successful device insertion in single attempt in
proseal laryngeal mask airway group. Time taken to insert Igel was significantly less (15.2 seconds) as compared to
proseal laryngeal mask airway (26.1 seconds).
Conclusions: The ease of insertion of Igel is better as compared to insertion of proseal laryngeal mask airway. The
success rate in first attempt insertion for Igel is higher as compared to proseal laryngeal mask airway. Time taken to
insert Igel was significantly less as compared to proseal laryngeal mask airway. However, there was no difference in
hemodynamic parameters and oxygen saturation between the two groups.
Keywords: Igel, Laryngeal mask airway, Proseal, Supraglottic devices, Ventilation
DOI: https://dx.doi.org/10.18203/2320-6012.ijrms20222856
Ashraf N et al. Int J Res Med Sci. 2022 Nov;10(11):2549-2554
International Journal of Research in Medical Sciences | November 2022 | Vol 10 | Issue 11 Page 2550
airway, which sits outside and creates a seal around the
larynx. It is relatively non-invasive as compared to
endotracheal intubation and in scenarios where
endotracheal intubation is not mandatory, laryngeal mask
airway has emerged as a formidable choice over
endotracheal intubation.3 Pediatric patients have specific
characteristics that are quite different from those of
adults, and their intubation therefore has a number of
unique features.4 This age group is likely to be associated
with higher rate of complications of laryngoscopy and
intubation, because of this, supraglottic airway devices
(SADs) have been increasingly used in recent years in
children.5
Supraglottic devices offer several advantages over
endotracheal tube with regards to ease of insertion,
hemodynamic stability, favourable respiratory mechanics,
decreased airway morbidity, reduced requirement of
drugs and smoother emergence from anaesthesia.
Insertion of supraglottic airway device causes less
laryngeal trauma and less sympathetic stimulation than
endotracheal tube (ETT).6,7 In cases of anticipated
difficult airway management, supraglottic airway devices
are increasingly preferred due to their efficacy and
safety.8 They can be used safely and effectively for both
spontaneous as well as controlled ventilation in pediatric
patients. Commonly used supraglottic airway devices
today are second generation ones, which are provided
with gastric channel for passing oro-gastric tube through
it in the stomach.9 While proseal laryngeal mask airway
has a pneumatic cuff to be filled with air to provide
proper oropharyngeal seal, Igel has temperature sensitive
self-inflating non pneumatic membranous cuff. It has a
buccal cavity stabilizer and integral bite block which
helps in alignment of the device with oropharyngeal
curvature of the patient and prevent malrotation. There is
a channel for gastric suction placement and an epiglottic
rest with a protective ridge which prevents down folding
of the epiglottis during insertion.10 It was designed to
create a non-inflatable, anatomical seal of the pharyngeal,
laryngeal and perilaryngeal structures while avoiding
compression trauma. The shape, softness and contour
accurately mirror the perilaryngeal anatomy to create the
perfect fit, so that compression, displacement and trauma
are significantly reduced and has cheaper manufacturing
costs due to simplicity of design.11
The various advantages of supraglottic airway devices
are less stimulation of sympathetic nervous system
leading to lower hemodynamic instability, the patient
even in light plane of anaesthesia better tolerates it, ease
of insertion and smooth recovery, avoidance of
laryngoscopy and muscle relaxant, they do not displace
bacterial colony from oral or nasal to lower respiratory
tract, in situation like cannot ventilate cannot intubate it is
used as a life saving device in securing the airway, less
injury to airway compared to endotracheal tube and
recovery and emergence time is less.12 But it has certain
disadvantages like, it does not provide protection against
aspiration so contraindicated in full stomach patients, not
useful in patients with glottic and supraglottic
obstruction, or pathology, it is not a definite airway,
patient with poor lung compliance cannot be
recommended as it needs high inflation pressure., difficult
to insert in patients with less mouth opening and in
patients with oral and cervical pathology like large goitre,
tumor.13,14
Supraglottic airway devices can cause complications like
gastric content aspiration, gastric distension, complete or
partial airway obstruction, traumatic injuries to the
tongue, soft palate, uvula, tonsils, epiglottis and
pharyngeal mucosa, dislodgement occurs accidentally
when not in proper position, cuff is overinflated or
inappropriate size is used, damage to laryngeal mask
airway(LMA), failure to inflate or deflate can occur,
bronchospasm, dysphagia and nerve injury may occur
during laryngeal mask airway (LMA) use.15,16
Aims and objectives
The aim of this study was to compare two supra glottic
airway devices, Igel and proseal LMA, with respect to
ease of insertion, number of insertion attempts, time
taken for placement of device and hemodynamic changes
during use of supraglottic airway device.
METHODS
This prospective, randomized observational study entitled
was conducted in the department of anaesthesiology and
critical care, Sher-i-Kashmir Institute of Medical
Sciences, Srinagar, from December 2019 to June 2021,
after obtaining approval from the ethical committee of the
institute. Sample size consisted of 80 patients who were
randomized into two groups with each group having 40
patients, group P (proseal) and group I (Igel).
Inclusion criteria
For selection of patients the inclusion criteria were
children between age group 2 to 8 years of either sex,
American Society of Anaesthesiologists (ASA) class I/II
and elective surgical procedures of duration not more
than 2 hours with no need for endotracheal intubation.
Exclusion criteria
Patients with anticipated difficult airway (mouth opening
of <2 finger, mallampati class 4, limited neck extension,
history of previous difficult intubation), restricted mouth
opening, cervical spine disease, patients with upper
respiratory tract infections, patients at the risk of
gastroesophageal regurgitation (e.g. hiatus hernia, full
stomach etc.), patients with airway related conditions
such as trismus, trauma or mass and patients undergoing
any oral or nasal surgeries, were excluded from the study.
After preoxygenating the child with 100% oxygen for 3
minutes, intravenous induction with propofol (2 mg/kg
Ashraf N et al. Int J Res Med Sci. 2022 Nov;10(11):2549-2554
International Journal of Research in Medical Sciences | November 2022 | Vol 10 | Issue 11 Page 2551
body weight) and fentanyl (2 μg/kg) was done. Following
induction, mask ventilation was performed until
conditions suitable for device insertion (lack of response
to jaw thrust, loss of eyelash reflex etc.) were obtained.
Size of the device was selected according to the body
weight of the patient. For Igel, size 2 was used for the
children weighing 10 to 25 kg and size 2.5 in those
weighing 25 to 35 kg. For proseal laryngeal mask airway
(PLMA) we used size 2 for children between 10 to 20 kg
weight and size 2.5 for those between 20 to 30 kg weight.
The cuff was then inflated according to the size of the
proseal LMA (PLMA) i.e.; 10 ml of air for size 2 and 14
ml of air for size 2.5.
Before inserting the device, we noted baseline
hemodynamic parameters including heart rate, systolic
blood pressure, diastolic blood pressure, mean arterial
pressure and oxygen saturation.
At the time of insertion of device, ease of insertion, total
number of attempts made to insert the device and the total
time taken for successful placement of the device were
recorded.
The ease of insertion was categorized as either easy (E)
or difficult (D). Supraglottic airway device insertion was
considered easy if no manipulation was required and if
there was a need to manipulate the airway, device
insertion was considered to be difficult.
The total number of attempts made for insertion of
supraglottic airway device were noted. The total time
taken for insertion of supraglottic airway device was
measured with the help of a stop watch. Time was
measured in seconds.
After the insertion of supraglottic airway device, changes
in hemodynamic parameters (heart rate, systolic blood
pressure, diastolic blood pressure, mean arterial pressure)
and oxygen saturation from baseline were recorded.
Before and after removal of the device, changes in
hemodynamic parameters (heart rate, systolic blood
pressure, diastolic blood pressure and mean arterial
pressure) and oxygen saturation was also noted. The
recorded data was compiled and entered in a spreadsheet
(Microsoft Excel) and then exported to data editor of
SPSS Version 20.0 (SPSS Inc., Chicago, Illinois, USA).
Continuous variables were expressed as Mean±SD and
categorical variables were summarized as frequencies and
percentages. Graphically the data was presented by bar
and pie diagrams. Student’s independent t-test or Mann
Whitney U-test, whichever feasible, was employed for
comparing continuous variables. Chi-square test or
Fisher’s exact test, whichever appropriate, was applied
for comparing categorical variables. A p value of less
than 0.05 was considered statistically significant. All p
values were two tailed.
RESULTS
This study was conducted to evaluate the two supraglottic
airway devices, proseal laryngeal mask airway (PLMA)
and Igel regarding ease of insertion, number of attempts
of insertion, total time taken for insertion of the device,
hemodynamic changes and effect on oxygen saturation at
different time intervals, in 80 patients of ASA grade I/II,
of either sex, aged 2 to 8 years going for elective short
surgical procedures with spontaneous ventilation.
Our study showed that the mean age of patients in two
groups was comparable. Mean age in group Igel was 4.1
years and in group proseal was 4.9 years. The difference
was statistically insignificant (p value ˃0.05).
Figure 1: Bar graph depicting mean age (in years) of
the patients in group I and group P.
The mean age (in years) of patients in group I was 4.1
years and in group p was 4.9 years. The groups were
comparable in mean age and the difference was
statistically insignificant (p value 0.142) (Figure 1).
Figure 2: Bar graph depicting the gender distribution
of patients in group I and group P.
In group I, 70% of the patients were male and 30% of the
patients were female. In group P, 82.5% of the patients
Ashraf N et al. Int J Res Med Sci. 2022 Nov;10(11):2549-2554
International Journal of Research in Medical Sciences | November 2022 | Vol 10 | Issue 11 Page 2552
were male and 17.5% of the patients were female
(Figure 2).
Figure 3: Bar graph depicting the comparison based
on duration of surgery (in minutes) in two groups.
Figure 3 shows the comparison based on duration of
surgery (minutes) in two groups. The mean duration of
surgery in group I was 74.1 minutes and in group P was
72.4 minutes. The difference was statistically
insignificant.
Figure 4: Bar graph depicting the mean supraglottic
airway device insertion time in group I and group P.
Figure 4 shows that mean supraglottic airway device
insertion time (seconds) in group I was 15.2 seconds and
in group P was 26.1 seconds. The difference between the
two groups regarding mean insertion time of supraglottic
airway device was statistically significant.
Figure 5 shows that in 95% of the cases in group I the
supraglottic airway device was inserted in single attempt
and in group P, in 77.5% of the cases the supraglottic
airway device was inserted in single attempt. The
difference between the two groups regarding average
number of attempts required for supraglottic airway
device insertion was statistically significant.
Figure 6 shows that in 95% of cases in group I,
supraglottic airway device was inserted easily and in 77.5
% of cases in group P the device was inserted easily. The
difference between the two groups regarding ease of
insertion of the device was statistically significant
(p<0.05).
Figure 5: Bar graph depicting the average number of
attempts required to insert the supraglottic airway
device in two groups.
Figure 6: Bar graph depicting mean difference
between the ease of insertion of supraglottic airway
devices in two groups.
Figure 7: Bar graph depicting comparison of mean
arterial pressure (mmHg) in two groups at
baseline, after device insertion, before
and after device removal.
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International Journal of Research in Medical Sciences | November 2022 | Vol 10 | Issue 11 Page 2553
Figure 7 shows the comparison of mean arterial pressure
(mmHg) in two groups at baseline, after device insertion,
before and after device removal. The mean arterial
pressure was 71.30 mmHg, 75.90 mmHg, 76.38 mmHg
and 77.25 mmHg at various time intervals for group Igel.
For group proseal mean arterial pressure was 70.23
mmHg, 76.25 mmHg, 76.65 mmHg and 77.15 mmHg at
different time intervals.
DISCUSSION
This study was conducted to evaluate the two supraglottic
airway devices, proseal laryngeal mask airway (PLMA)
and Igel regarding ease of insertion, number of attempts
of insertion, total time taken for insertion of the device,
hemodynamic changes and effect on oxygen saturation at
different time intervals, in 80 patients of ASA grade I/II,
of either sex, aged 2 to 8 years going for elective short
surgical procedures with spontaneous ventilation.
Our study showed that the mean age of patients in two
groups was comparable. Mean age in group Igel was 4.1
years and in group proseal was 4.9 years. The difference
was statistically insignificant (p value ˃0.05). The gender
distribution, height (cm) and weight (kg) of the patients
in both the groups were comparable and were statistically
insignificant (p value >0.05).
The hemodynamic parameters and effect on oxygen
saturation at different time intervals were also
comparable and statistically insignificant (p value >0.05).
In this study we found that both proseal laryngeal mask
airway (PLMA) and Igel were successfully inserted in all
the patients and there was no case of failed insertion in
any of the two groups. The ease of insertion of Igel was
found to be better than proseal laryngeal mask airway. In
group Igel 38 patients (95%) had easy insertion of the
device and in 2 patients (5%) insertion of the device was
difficult. The group proseal showed 31 patients (77.5%)
had easy insertion and 9 patients (22.5%) had difficulty in
insertion of the device. This was statistically significant.
P value was ˂0.05.
The results from our study were similar to those obtained
in the study conducted by Chauhan et al titled
“Comparison of clinical performance of the Igel with
LMA proseal”, who found that Igel was easier to insert
with a better anatomic fit.10
In our study we also compared the total duration of
supraglottic airway device insertion and it was found that
the total time taken to insert Igel was less as compared to
proseal laryngeal mask airway. Igel had a mean duration
of 15.2 seconds and proseal laryngeal mask airway had a
mean duration of 26.1 seconds. P value was <0.001
which was statistically significant.
Our study regarding total time taken to insert the device
correlates with the study conducted by Pratibha et al.17
In our study we also compared the total number of
attempts that were made to insert Igel and proseal
laryngeal mask airway and it was found that 38 patients
(95%) had successful supraglottic airway device insertion
in a single attempt and 2 patients (5%) had success in
second attempt in group Igel. In group proseal, however,
31 patients (77.5%) had a successful device insertion in a
single attempt and 9 patients (22.5%) had success in
second attempt. This difference was statistically
significant. P value was <0.05.
Similar results were also found in the study conducted by
Jadhav et al titled “comparison of two supraglottic airway
devices in short surgical procedures”, who found that the
success rate of first attempt insertion was more with
group Igel.18 It was found that the first attempt success
rate was higher with Igel as compared to proseal
laryngeal mask airway.
Therefore, in our study, Igel was found to be better than
proseal laryngeal mask airway regarding ease of
insertion, total number of attempts and its placement is
also rapid. This may be attributed to the fact that Igel is
made up of a thermoplastic elastomer with a soft
durometer which has a gel like feel. This material makes
the device easy to introduce. Secondly it has a buccal
cavity stabilizer and integral bite block which helps in
alignment of the device with oropharyngeal curvature of
the patient and prevents malrotation. It also has a
temperature sensitive self-inflating non-pneumatic
membranous cuff, that accurately mirror the peri-
laryngeal anatomy to create a perfect fit hence less
chances of displacement.
Supraglottic airway devices can cause complications like
gastric content aspiration, gastric distension, complete or
partial airway obstruction, traumatic injuries to the
tongue, soft palate, uvula, tonsils, epiglottis and
pharyngeal mucosa, dislodgement occurs accidentally
when not in proper position, cuff is overinflated or
inappropriate size is used, damage to laryngeal mask
airway (LMA), failure to inflate or deflate can occur,
bronchospasm, dysphagia and nerve injury may occur
during laryngeal mask airway (LMA) use.
Our study has few limitations that need discussion. We
excluded children with difficult airway. Therefore, the
results of this study cannot be concluded for patients with
difficult airway. Also because of the small sample size,
our study offers almost no conclusive evidence of the
safety of the device, which requires data from a
considerably larger cohort in a routine practice.
CONCLUSION
On the basis of our study it can be concluded that the ease
of insertion of Igel is better as compared to insertion of
proseal laryngeal mask airway. The success rate in first
attempt insertion for Igel is higher as compared to proseal
laryngeal mask airway. Time taken to insert Igel is
Ashraf N et al. Int J Res Med Sci. 2022 Nov;10(11):2549-2554
International Journal of Research in Medical Sciences | November 2022 | Vol 10 | Issue 11 Page 2554
significantly less as compared to proseal laryngeal mask
airway. However, there is no difference in hemodynamic
parameters and oxygen saturation between the two
groups.
Funding: No funding sources
Conflict of interest: None declared
Ethical approval: The study was approved by the
Institutional Ethics Committee
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Cite this article as: Ashraf N, Zargar OU, Albina A,
Farooqi A. Comparative study of Igel with proseal
LMA for ease of insertion and effect on
hemodynamics in pediatric patients. Int J Res Med
Sci 2022;10:2549-54.