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Original Research Article DOI: 10.18231/2394-4994.2018.0008
Indian Journal of Clinical Anaesthesia, January-March, 2018;5(1):43-49 43
A prospective randomised comparative study of proseal LMA, I-gel and
endotracheal tube in laparoscopic cholecystectomy
Ravindra Kumar Gehlot1, Shekhar Suman Saxena2,*, Lalit Kumar Raiger3
1Assistant Professor, 2Resident, 3Senior Professor, Dept. of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan, India
*Corresponding Author:
Email: drshekharsuman3@gmail.com
Received: 23rd May, 2017 Accepted: 19th August, 2017
Abstract
Introduction: The major responsibility of the anesthesiologist is to provide adequate ventilation to the patient because airway
related problems are still the most common cause of anaesthesia related morbidity and mortality. The use of I-gel has been
reported in laparoscopic surgeries and was found equally effective ventilatory device as PLMA. Therefore, we planned this study
to compare I-gel and PLMA with ET tube in patients undergoing laparoscopic cholecystectomy.
Materials and Methods: This prospective study was conducted on 90 patients of both sex, 18-60 years age, ASA grade I-II,
scheduled for elective laproscopic surgery under general anaesthesia. All patients were randomised into three groups of 30
patients each; Group I (I-gel), Group P (PLMA), Group E (ET Tube). Attempts of insertion of devices, effective airway time and
easiness of gastric tube; hemodynamic parameters (HR, MAP, SpO2 and EtCO2) were recorded.
Results: There was significantly less 2nd attempt required in I-gel group(10%) as compared with ET tube (36.7%) and PLMA
(13.3%),(p=0.019). Laryngopharyngeal morbidity were significantly more in Group E as compared to Group P and I (p<0.05).
Hemodynamic changes were significantly higher in Group E immediately after intubation which persisted for 3 minutes and
immediately after extubation (p= 0.00).
Conclusion: Supraglottic Airway Devices (PLMA and I-gel) were as effective as ET tube in establishing airway and the
haemodynamic stability is better then ET tube in laparoscopic cholecystectomy.
Keywords: Endotracheal tube, Proseal LMA, I-gel, Laproscopic cholecystectomy, Supraglottic Airway Devices.
Introduction
Common cause of anaesthesia related morbidity
and mortality are still the airway related problems1 and
it is the anaesthesiologists responsibility to provide &
maintain adequate ventilation.2 Gynecologic and
general surgery procedure and now-a-days bariatric
surgery are done by laparoscopic tachnique.3 The
laparoscopic surgery had some common problems,
which are a) Intra-peritoneal or extra-peritoneal CO2
insufflation; b) Raised intra-abdominal pressure.
Increased risk of pulmonary aspiration.
So the anaesthesiologist have to ensure a patent
airway along with adequate ventilation at high airway
pressures. Archie Brain developed the Pro-Seal LMA
(PLMA) in the late 1990's with improved ventilatory
characteristics.4 In patients who require PPV and for
operative procedures in which intra-operative gastric
drainage or decompression is desirable (laparoscopy),5
PLMA may be more suitable than the classical LMA.
The limitations of PLMA are demand for careful
handling to prevent cuff damage, relative difficulty of
insertion and it is costly.6 The Intersurgical Ltd.
(Wokingham, UK) has a supraglottic airway device ‘I-
gel’ which is cheap, cuffless and can be used as a
reasonable alternative to endotracheal tube during
pressure controlled ventilation (moderate airway
pressure).7,8 Various studies reported that I-gel is found
equally effective device as Proseal LMA to provide
positive pressure ventilation in laproscopic surgeries
but has less seal pressure as compared to PLMA.9
However, there are very few studies with limited data
that compare I-gel and PLMA with Endotracheal tube
to assess their performance in anaesthetized and
artificially ventilated patients scheduled for lap surgery
(cholecystectomy).
Therefore, this study was planned to compare I-gel
and PLMA with standard endotracheal tube regarding
(a) Efficacy in controlling airway for oxygenation and
ventilation; (b) Ease of insertion; (c) Hemodynamic
changes and complications in patients posted for
laparoscopic cholecystectomies.
Materials and Methods
After institutional ethics committee (IEC)
approval, this prospective, randomized, controlled study
was done from January 2016 to December 2016, at
M.B. Government Hospital, attached to RNT Medical
College, Udaipur, Rajasthan. 90 patients of 18-60 years
of age, both sex, ASA I – II grade, scheduled for
elective laparoscopic cholecystectomy under general
anaesthesia were included and informed written consent
was taken from each patients. All these patients were
subjected to pre-anesthetic evaluation and were
enquired about the history of past prolonged illness and
drug therapy; and routine investigations like hemogram,
complete blood count, blood urea, creatinine, blood
sugar (fasting), liver function tests, chest X-ray, and
Ravindra Kumar Gehlot et al. A prospective randomised comparative study of proseal LMA….
Indian Journal of Clinical Anaesthesia, January-March, 2018;5(1):43-49 44
electrocardiography tests were carried out during this
evaluation.
Exclusion criteria: The exclusion criteria were patients
with known case of hypertension, cervical spine
disease, anticipated difficult airway, cardiovascular
pathology, history of sore throat within the previous 10
days, history of gastro-esophageal disease, those with
severe asthma, restrictive lung disease, at risk of
pulmonary aspiration, BMI >35 kg/m2, and had any
contraindication to Supraglottic airway device.
The primary outcome measure was the
establishment of the airway with the supraglottic airway
devices (SAD). The secondary outcome measure was
time taken to establishment of the airway,
hemodynamic alterations and the leak pressures. Based
on the pilot study difficult establishment of airway
device was 60 % less in I-gel as compared to Proseal
LMA. When taking a power of 80% and alpha error of
<0.05 in two tailed test, the number of patients required
were 22 in each group. To compensate for drop outs we
decided to include 30 patients in each group.
For randomisation and group allocation a total of
92 patients were assessed for eligibility and 2 patients
were excluded because of not meeting the inclusion
criteria. Using sealed envelope technique 90 patients
were randomized in 3 groups according to use of
devices as follows; Group I (n=30): I-gel, Group P
(n=30): Proseal LMA, Group E (n =30): ET Tube.
After overnight fasting, patient was taken in O.T.
and monitoring was done using pulse oximetry, ECG
and non-invasive blood pressure measurement.
Intravenous line was secured with 20/18 G cannula.
Ringer lactate infusion was started. As per institutional
protocol patient was premedicated. After pre-
oxygenation, anaesthesia was induced with intravenous
propofol 2 mg kg-1 and vecuronium 0.1 mg kg-1
intravenously. I-gel and PLMA was lubricated with a
water soluble jelly. Once adequate depth of anaesthesia
was achieved, I-gel, PLMA or endotracheal tube was
inserted by experienced anaesthesiologist as per group
allocation. Proseal LMA was inserted by finger
guidance technique. Correct insertion and establishment
of an effective airway was confirmed by capnography
trace, normal thoracoabdominal movement, lack of
gastric insufflation (by epigastric auscultation) and
absence of gas leak. If an effective airway with I-gel
and PLMA was not achieved, the device was removed
and re-inserted. Two attempts of I-gel and PLMA
insertion was performed before the attempt was labeled
as failure and endotracheal tube intubation was then
done to secure the airway. After fixing the I-gel or
PLMA, gastric tube (Ryle’s tube) was inserted through
gastric channel in group-I, drainage tube in group-P and
nasally in group E. Anaesthesia was maintained with
propofol infusion (50-200 μg/kg/min). Intermittent
atracurium was used to maintain muscle relaxation if
required. The oropharyngeal leak or seal pressure was
determined by closing the APL (adjustable pressure
limiting) valve and allowing a fresh gas flow of 3
L/min. Airway pressure at equilibrium or when there
was audible leak from throat was noted. The maximum
pressure that was allowed was 40 cm of H2O. For
standardization intra-abdominal pressure was
maintained at 8-12 mm of Hg. Patient was reversed
with inj. neostigmine 0.06 mg/kg plus inj.
glycopyrrolate 0.004 mg/kg i.e. at end of surgery and
the devices were removed. The data were recorded (by
second anaesthesiologists) as follows: 1.The number of
attempts of insertion of airway device were recorded; 2.
Ease of insertion of device was defined as “Easy”: no
resistance to insertion in pharynx in a 1st attempt,
“Difficult”: if resistance was encountered during
placement, or requires >1 attempt. “failure”: if could
not be inserted in three attempts; 3. The effective
airway time was recorded and defined as ‘time between
picking up the airway device and obtaining first
effective ventilation, for a maximum of two attempts
for the same patient’. As achievement of first successful
ventilation assessed by chest expansion and EtCO2
monitor was defined as end point; 4. Oropharyngeal
leak was assessed clinically by the audible leak at
mouth or by the audible noise using a stethoscope
placed just lateral to the thyroid cartilage; 5. The ease
of insertion of gastric tube No.12 (Ryle’s tube) through
the SAD was recorded as Easy: as in first attempt;
Difficult: if not inserted in 2 attempts. Correct
placement was ascertain by aspiration of gastric
contents or epigastric auscultation with injection of air;
6. Mean Airway Leak or Seal pressure; 7.Vitals
Parameters: Intraoperative heart rate, Non-invasive
blood pressure (Mean Arterial Pressure, MAP),
Peripheral oxygen saturation (SpO2) and end-tidal
carbon dioxide (EtCO2) were recorded before
induction, at the time of insertion of airway device, at 1,
3 and 5 minutes after insertion of device, after
achieving carboperitoneum, then after every 15 minutes
till the end of surgery and during removal of devices.
Adequate ventilation and oxygenation was maintained
by keeping SpO2 >95% and EtCO2 < 45 mmHg. If
ventilation and oxygenation could not be maintained
intraoperatively in PLMA and I-gel group, they were
replaced with endotracheal tube. 8. Following removal
of device, coughing, blood staining of device, trauma to
the lips, tongue or teeth was recorded. 9. Any
intraoperative respiratory and cardiac complications
(desaturation, bronchospasm, laryngospasm,
hypertension, hypotension, arrhythmias, ischemic event
etc.) were noted and their management was recorded.
10. After 24 hours of surgery 2nd anaesthesiologist who
was not aware of groups interviewed the all patients
regarding the presence or absence of sore throat and
hoarseness of voice.
For statistical analysis evidence of one qualitative
character on groups was tested using Chi square test
and difference between means of different quantitative
data among groups was tested by F test using one-way
Ravindra Kumar Gehlot et al. A prospective randomised comparative study of proseal LMA….
Indian Journal of Clinical Anaesthesia, January-March, 2018;5(1):43-49 45
ANOVA. The analysis was considered as statistically
significant if p<0.05 [using IBM Statistical Package
for the Social Sciences (SPSS) version 2016].
Results
Group P, I and E were statistically comparable
regarding mean age, weight, height, body mass index
(BMI) and sex distribution. (Table 1)
For insertion of airway device second attempt was
required in 10.0% cases in I-gel group which was found
to be significantly less as compared to insertion of ET
tube (36.7%) and Proseal LMA (13.3%)
cases,(p=0.019). However, none of the patient in all
three groups had failed insertion. (Table 2) Gastric tube
(Ryle’s tube) was inserted in 1st attempt in 28 patients
of Group P, 25 patients of Group I and only 16 patients
of Group E ( statistically significant, p= 0.001). Mean
time of insertion of airway device was significantly
longer in Group E as compared to Group I and Group
P,(p=0.000), I and P group were not significant. Mean
Airway Leak Pressure (MALP) was achieved
significantly higher in Group P then Group I,
(p=0.000).
Laryngopharyngeal morbidity with regards to
coughing, blood staining of device and sore throat were
significantly more common in Group E as compared to
Group P and Group I (p<0.05). Incidence of trauma to
lip /tongue and hoarseness of voice were statistically
comparable among the three groups.
Hemodynamic changes (Heart rate & MAP)
were significantly higher in Group E immediately after
intubation (p= 0.002) and persisted for 3 minutes
thereafter (p= 0.00) and immediately after extubation
(p= 0.00); while in Groups P and I, the HR and MAP
increased just after insertion of the devices and
remained comparable in two groups at all other time
intervals. [Figure 1 & Fig. 2]
The oxygen saturation (SpO2) and end tidal carbon
dioxide (EtCO2) before or during carboperitoneum
were statistically comparable in the three groups.
Table1: Demographic characteristics
Variance
Group P(n=30)
Group I(n=30)
Group E(n=30)
P value
Age (yrs)
41.87±9.8
40.67±8.9
40.53±7.7
0.81
Weight (kg)
55.00±2.8
54.63±5.6
54.67±4.9
0.9
Height (cm)
155.8±3.8
156.93±4.79
155.73±3.85
0.4
Sex (M/F)
5/25
6/24
11/19
0.155
BMI (kg/m2)
22.83±1.23
21.97±1.54
22.37±1.62
0.08
Table 2: Laryngopharyngeal morbidity among various groups
Variance
Group P
(n=30)
Group I
(n=30)
Group E
(n=30)
P value
Insertion of airway
device
1 attempt
26 (86.7%)
27 (90%)
19 (63.3%)
0.019
2 attempts
4 (13.3%)
3 (10%)
11 (36.7%)
3 attempts
0 (0%)
0 (0%)
0 (0%)
Failed
0 (0%)
0 (0%)
0 (0%)
Gastric tube (Ryle’s
tube) insertion
1 attempt
28 (93.3%)
25 (83.3%)
16 (53.3%)
0.001
2 attempts
2 (6.7%)
5 (16.7%)
14 (46.7%)
Insertion time of airway device
(seconds)
28.43±5.51
17.33±5.52
34.10±5.10
0.000
Mean Airway Leak Pressure
(MALP) (cm of water)
32.00±1.41
22.90±2.35
-
0.00
Morbidity at removal of device
Coughing
2 (6.7%)
1 (3.3%)
8 (26.7%)
0.01
Blood stain on airway devices
3 (10%)
2 (6.7%)
10 (33.3%)
0.01
Tongue or lip trauma
3 (10%)
1 (3.3%)
3 (10%)
0.53
Post- operative morbidity (24 hrs after surgery)
Sore throat
3 (10%)
1 (3.3%)
9 (30%)
0.009
Hoarseness of voice
2 (6.7%)
1 (3.3%)
3 (10%)
0.58
Ravindra Kumar Gehlot et al. A prospective randomised comparative study of proseal LMA….
Indian Journal of Clinical Anaesthesia, January-March, 2018;5(1):43-49 46
Flow Chart of Study Patients
Fig. 1: Comparison of heart rate in three groups at different time intervals
Ravindra Kumar Gehlot et al. A prospective randomised comparative study of proseal LMA….
Indian Journal of Clinical Anaesthesia, January-March, 2018;5(1):43-49 47
Fig. 2: Comparison of mean arterial pressure in three groups at different time intervals
Discussion
SAD’s have several well-established advantages in
comparison to endotracheal tube including: easy
insertion,9 less hemodynamic upset during
anaesthesia,10 lower incidence of sore throat.11 Hence
there has been a growing trend towards substituting an
SAD for endotracheal tube for controlled ventilation in
patients with minimal risk of aspiration. Laparoscopic
surgery has been shown to adversely affect
intraoperative pulmonary mechanics, thus providing the
most effective way to test the efficacy of an airway
device; as here the pulmonary compliance is decreased
and the resistance is increased leading to high airway
pressures.12 SAD like proseal LMA provide higher
oropharyngeal seal pressure and it had separate
esophageal and laryngeal passage are desirable for
laparoscopic surgery, as the seal pressure serve as an
index of airway/respiratory mechanics.13
1. Ease of insertion of airway device: We assessed
that I-gel was inserted with more ease in first
attempt in (90%) patients as compared to
endotracheal tube where only (63.3%) patients
were intubated in 1st attempt (statistically
significant, p=0.019). However PLMA was
inserted with similar ease as I-gel, (86.7%). Second
attempt was required in 4(13.3%), 3(10.0%) and
11(36.7%) patients respectively in group P, I and
E. None of the patient required third attempt/ failed
device insertion in any groups. Thus insertion of I-
gel was significantly easier as compared to
endotracheal tube (p=0.019) but similar to PLMA.
Najeeb et al14 stated that I-gel was easier to
insert with higher success rate in 1st attempt
(92.5%) than Proseal LMA (85%) and endotracheal
tube (82.5%) but it was not statistically significant,
and all devices were inserted successfully in all
patients. Singh I et al15 found that the ease of
insertion was more (96.6%) with I-gel. These
studies including present show that the I-gel had
easier insertion than endotracheal tube because of
the design which was inspired by physiology of the
perilaryngeal framework itself. The shape, softness
and contour accurately mirror image the
perilaryngeal anatomy to create the perfect seal and
no cuff inflation is required.
2. Mean insertion time of airway device: In our
study, mean insertion time was significantly longer
in Group E (34.10±5.10 sec), as compared to
Group I (17.33±5.52 sec) and Group P (28.43±
5.51 sec) (p=0.000). Badheka et al16 compared I-
gel with ETT and found that the mean insertion
time was significantly less in I-gel insertion (11.28
± 2.91seconds) when compared with ETT (14.33 ±
1.56 sec). Helmy A et al17 found that the mean
insertion time was 15.6±4.9 sec in I-gel group. The
difference in insertion times between I-gel, PLMA
and ETT may be due to the fact that the I-gel is
easily inserted and does not have a cuff that needs
to be inflated before the first breath, which was our
end-point for the insertion time. This leads to
shorter insertion time in I-gel. However PLMA
took longer time then I-gel due to time taken in
inflating the cuff and due to relatively larger size.
3. Ease of ryle’s tube insertion: We observed
that ryle’s tube was inserted in 93.3% patients
in 1st attempt of Group -P, 83.3% patients of
Group-I and 53.3% patients of Group-E
(statistically significant, p= 0.001). Singh I. et
al15 found that the ease of insertion of ryle’s
tube was 100% with I-gel. Saraswat N. et al18
reported that the success rate of NG tube
insertion in 1st attempt was 66.67% via nasal
route in intubated patients. These studies show
that the SAD’s (PLMA and I-gel) have
significantly higher success rate for gastric
tube insertion than conventional placement via
nasal route, which required in patient with
endotracheal tube. This can be explained by
the fact that the SAD’s have a separate port for
gastric tube insertion through which gastric
Ravindra Kumar Gehlot et al. A prospective randomised comparative study of proseal LMA….
Indian Journal of Clinical Anaesthesia, January-March, 2018;5(1):43-49 48
tube can be easily inserted without disturbing
airway / coiling in airway tract.
4. Oropharyngeal leak and mean airway leak
pressure: There were 2 (6.7%) cases in I-gel
group who had oropharyngeal leak which
disappeared after 5 minutes because I-gel
comprises a soft gel like non-inflatable cuff
made of thermoplastic elastomer which swell
after some time and provide adequate seal.
None of the patients in both groups of present
study had oropharyngeal leak after
pneumoperitoneum throughout surgery. It has
been reported that the seal of the I-gel seems
to improve over time due to the thermoplastic
cuff warming to the body temperature.13 In
present study, Oropharyngeal leak was
assessed clinically by palpation (with hand
placed over laryngeal area) or presence of
audible leak during positive pressure
ventilation (PPV), as we did not have device to
measure leak or leak pressure. In present study
the MALP was achieved significantly higher
in Group P (32.00±1.41 cm of H2O) then
Group I (22.90±2.35 cm of H2O); statistically
significant (p=0.000) may be because PLMA
has a dorsal cuff, in addition to the peripheral
cuff of LMA, which pushes the mask anterior
to provide a better seal around the glottic
aperture and permits high airway pressures
without leak.14 Uppal V et al8 found MALP for
the I-gel was 28 [20–35.5] cm H2O using the
auscultation method and 28 [20.5–36] cm H2O
using the manometer stabilization method,
(Statistically not significant, p=0.068). Airway
leak pressures for all the participants when
intubated consistently reached 40 cm H2O.
Badheka et al16 compared I gel with ETT and
found MALP of 25.27 cm of H2O. Saraswat et
al18 reported that in PLMA group, MALP of
35 cm of H2O. Incidence of leak was 0% in all
the groups in our study because we measured
it as if audible throat sound is present. This
would be present only if major leak was
present. Moreover we studied patients who
had normal airway; present study results could
be different if obese patients or difficult
airway patients were included. However the
method which we used for measuring MALP
was similar to Saraswat et al18 and was
effective.
5. Hemodynamic changes (Heart rate & mean
arterial pressure): In present study we found
significant changes in HR and MAP
immediately after insertion, persisted till 3
minutes after intubation and during extubation
in ET tube. Increase in the HR and MAP in
PLMA and I-gel group were only after
insertion of device. It is attributed to
sympathetic stimulation during laryngoscopy
and the passage of the ET through the vocal
cords.19 The Proseal LMA and I-gel being
supraglottic devices do not require
laryngoscopy and probably do not evoke a
significant sympathetic response. Attenuation
of this response may be due to diminished
catecholamine release. Our result correlates
with the other studies.14,18 In which they
observed hemodynamic perturbations, were
more with tracheal intubation and stable
hemodynamic observed with PLMA and I-gel.
6. Laryngopharyngeal morbidity: In our study
laryngopharyngeal morbidity (coughing, blood
staining of device and sore throat) were found
more in group E as compared to groups P and I
(p= 0.01; statistically significant).The trauma
to lip/ tongue and hoarseness of voice were
more common in endotracheal group but
statistically not significant (p=0.58).Similar
results were seen in other studies.14,15,17,18 As
with I-gel and PLMA mucosal pressures
achieved are usually below pharyngeal
perfusion pressure.20
Limitation of our study were: a). We did not have
facility to measure leak pressure, we assessed
Oropharyngeal leak clinically by palpation with hand
placed over laryngeal area or presence of audible leak
over laryngeal area; b). The sample size of our study
was small i.e. 30 patients in each PLMA, I-gel and ETT
group so that our data cannot be generalized and need
further study with large study group; c). The study was
conducted in elective surgeries in controlled setting, so
we could not find I-gel efficacy in emergency
resuscitation / surgeries.
Conclusion
We conclude that to establish airway the
Supraglottic Airway Devices (PLMA and I-gel) are
equally effective as ET tube. These supraglottic airway
device are easy to insert and maintain hemodynamic
parameter with lesser post-operative complications as
compared to ET tube in laparoscopic cholecystectomy
surgery under general anaesthesia with controlled
ventilation.
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