A Comparative Study Between I-Gel And

Endotracheal Tube For Volume Controlled

Ventilation In Patients Undergoing Laparoscopic
Cholecystectomy

Dr. Azka Zuberi1, Dr. Dipika Jana2, Dr. Vineet Tyagi3, Dr. Bhavika Singla4

1. Associate professor, Department of Anaesthesia, Muzaffarnagar Medical College, Muzaffarnagar (U.P.), India
2. PG Resident, Department of Anaesthesia, Muzaffarnagar Medical College, Muzaffarnagar (U.P.), India
3. Assistant professor, Department of Anaesthesia, Muzaffarnagar Medical College, Muzaffarnagar (U.P.), India
4. Assistant professor, Department of Anaesthesia, Muzaffarnagar Medical College, Muzaffarnagar (U.P.), India
Corresponding author
Dr. Bhavika Singla
Assistant professor, Department of Anaesthesia, Muzaffarnagar Medical College, Muzaffarnagar (U.P.), India
E-mail id: bhavikasingla201@gmail.com
DOI: 10.47750/pnr.2022.13.S09.421

Aim and objectives: To compare the clinical efficacy (haemodynamic changes and ventilator parameters) and safety profile
of I-gel with Endotracheal tube for volume-controlled ventilation during laparoscopic cholecystectomy.
Materials and methods: This Hospital-based prospective observational Study was done among patients undergoing
laproscopic cholecystectomy at a tertiary care hospital. The study population was divided into 2 groups of 30 patients each.
Group 1 consisted of patients undergoing Laparoscopic cholecystectomy under General Anaesthesia using I-gel to secure the
airway and Group 2consisted of Laparoscopic cholecystectomy under general anaesthesia using Endotracheal tube(ETT).
Haemodynamic changes, ventilator parameters and complication were recorded at different time intervals.
Results: The mean Heart rate, mean Systolic blood pressure, mean Diastolic blood pressure and mean end tidal carbon dioxide
(ETCO2) after placement, at 15 minutes, 30 minutes, 45 minutes, after removal and 5 minutes after removal were found to be
significantly higher among Endotracheal tube group compared to the I-Gel group. The Mean leak pressure at insertion, 10
minutes after Pneumoperitoneum and prior to release of Pneumoperitoneum was significantly more among Endotracheal tube
compared to I-Gel.
Conclusion: In terms of hemodynamic stability, leak pressures, and post-operative discomfort, I-gel offers a superior, safe,
and dependable alternative to endotracheal intubation in patients undergoing laparoscopic cholecystectomy.

Keywords: Endotracheal tube, Heart rate, I-Gel, Laparoscopic Cholecystectomy

Introduction
The development of laparoscopic surgeries has revolutionised the surgical field and in turn the anaesthetic
management. Airway handling while laryngoscopy and endotracheal intubation, creation of pneumoperitoneum
and reverse trendelenberg position during laparoscopic procedures can cause hemodynamic changes and changes
in airway pressures that can in turn lead to laryngospasm, bronchospasm, hypoxia, hypercarbia or arrhythmias.
Until recently, the cuffed Endotracheal tube (ETT) was considered as gold standard for providing a safe
glottic seal for procedure under general anaethesia. The Endotracheal tube is a device that is inserted through the
larynx into the trachea to convey gases and vapors to and from lungs.

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Over the last decade, supraglottic airway devices (SADs) especially second-generation devices have been adopted
in laparoscopic procedures. Of the various advantages of SADs over endotracheal intubations few are ease of
placement, lesser requirement of neuromuscular blockade, more hemodynamic stability and lower incidence of
postoperative airway morbidity.[1‑4]
However, there are some suspicions about the use of SADs with positive pressure ventilation (PPV) such
as in laparoscopic procedures, where creation of pneumoperitoneum may lead to increase in airway pressures
above the oropharyngeal seal pressure (OSP) of the used SADs, and may result in insufficient ventilation, gastric
insufflation and increased risk of regurgitation and even pulmonary aspiration.[5,6]
The second-generation SADs with gastric channel provide higher sealing pressures and more complete
airway protection than the classic laryngeal mask airway.[7-10] The I-gel [Intersurgical Ltd, Wokingham, UK] is a
new addition to the ever-expanding field of second generation SAD with a non-inflatable cuff which has several
potential advantages over other SADs.
The use of a SAD is a challenge in laparoscopic surgeries. The cardiopulmonary changes during
laparoscopy are complex and depend on the interaction of the patient’s pre-existing cardiopulmonary status, the
anaesthesia technique and several surgical factors including intra-abdominal pressure (IAP), carbon dioxide
(CO2) absorption, patient position and duration of the surgical procedure. [11] Studies in the past have evaluated
the use of I-Gel for controlled ventilation. However, there remains a dearth of literature for use of SADs in
laparoscopic surgeries, especially in the elderly and in patients with limited cardio-pulmonary reserve.
Therefore, in an attempt to compare the clinical efficacy and safety profile of I-gel with endotracheal tube
during general anaesthesia in healthy adult patients undergoing laparoscopic cholecystectomy, this prospective
study was conducted.

Materials and method

This hospital based observational study was conducted, after obtaining clearance from Institutional Ethical
Committee, in patients undergoing laparoscopic cholecystectomy at a tertiary care hospital. The study population
was randomly divided into 2 groups of 30 patients each. Group 1 consisted of patients undergoing laparoscopic
cholecystectomy using I-gel while Group 2 consisted of laparoscopic cholecystectomy surgeries using
endotracheal tube (ETT) to secure the airway.

Inclusion criteria
All the patients of American society of Anaesthesiologists physical status grade 1 and 2, aged 18-60 years,
scheduled for elective laparoscopic cholecystectomy under general anaesthesia.

Exclusion criteria
Patients with difficult airway, obesity (according to BMI), patients with any chronic illness and patients with
increased risk of aspiration (hiatus hernia, pregnancy, gastro-oesophageal reflux disease and full stomach) were
excluded from the study.

Methodology -
After taking written informed consent, a thorough pre-anaesthetic check-up was carried out including the detailed
history and physical examination of all the patients. Airway examination and all the necessary investigations were
done.
All patients were shifted to the operation theatre (OT) 1 hour prior to surgery. An intravenous (i.v.) line was
secured with 20G i.v cannula, and ringer lactate infusion was started. The multipara monitors were attached to
measure heart rate, non-invasive blood pressure and oxygen saturation (SpO2) for all the patients in the pre-
operative area.
Patients were then taken inside the OT and all patients were uniformly premedicated with injection
Metoclopramide 10mg, Midazolam 0.05mg/kg, Glycopyrrolate 0.004mg/kg and i.v. Fentanyl 2mcg/kg. After
preoxygenation with 100% O2 for 3 minutes anaesthesia was induced with Propofol (2mg/kg) and Vecuronium
(0.1mg/kg). Airway devices(either endotracheal tube or I-gel)of appropriate size were inserted and patients were
put on a ventilator in volume control mode, and anaesthesia was maintained with Isoflurane, 60% N2O in oxygen
and Vecuronium 0.05mg/kg maintenance dose. All procedures were performed by an experienced

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anaesthesiologist and the duration of laryngoscopy, intubation and I-Gel insertion was limited to the minimum
possible time in all the patients. Vital parameters i.e., Heart Rate (HR), Mean arterial pressure (MAP), Systolic
blood pressure (SBP), Diastolic blood pressure (DBP), SpO2 and end- tidal carbon dioxide (EtCO2) of patients
were recorded at baseline, after placement, at 15 minutes, 30 minutes, 45minutes, at removal & 5 minutes after
removal. Mean leak pressure (in cms of H2O) was recorded at insertion, 10 min after Pneumoperitoneum, prior
release of Pneumoperitoneum &after release of Pneumoperitonium. At the end of surgery, residual neuromuscular
blockage was reversed with injection Neostigmine 0.05mg/kg and injection Glycopyrrolate 0.01mg/kg IV. Post-
operative complications in terms of blood staining of ETT or I-gel and sore throat were observed in all patients.

Statistical analysis
The statistical analysis of data was carried out using statistical software SPSS version 21.0. The student t-test was
used for comparing the mean values between the 2 groups whereas chi-square test was applied for comparing the
frequency. The p-value was considered to be significant when less than 0.05.

Results
The demographic characteristics in both the groups were found to be comparable. As depicted in table 1 and table
2, heart rate and systolic blood pressure was observed to be significantly higher among endotracheal group than
in I-gel group after placement, at 15 minutes and at 30 minutes (p value <0.05). Similar results were observed
with changes in diastolic blood pressure and mean arterial pressure (as shown in table 3 and 4). However, there
were no significant changes in the SpO2 among the two groups (table 5).
The mean EtCO2 (as depicted in table 6) was significantly higher among I-gel group compared to the endotracheal
tube group immediately after placement (p-value = 0.028). The mean leak pressure (as depicted in table 7) was
significantly higher among I-gel group compared to endotracheal tube. Blood staining was significantly more
among I-Gel group (3 out of 30 patients) and sore throat was observed to be significantly more among the
Endotracheal tube group than I-Gel group (as depicted in table 8).

Table 1: Distribution of study population according to Heart rate

I-Gel Endotracheal tube Mean t-test p-value
Heart rate Mean SD Mean SD Difference value
At baseline 72.73 2.53 72.37 4.84 0.37 0.374 0.581
After placement 69.63 1.73 73.67 5.46 -4.03 -3.856 0.008*
15 minutes 72.17 1.93 76.17 5.74 -4.00 -3.620 0.001*
30 minutes 72.70 2.68 78.67 6.20 -5.97 -3.217 0.002*
45 minutes 72.83 2.21 76.30 2.37 -3.47 -0.789 0.433
After Removal 81.20 5.57 81.50 6.38 -0.30 -0.194 0.847
5 minutes after 72.30 5.41 72.90 6.42 -0.60 -0.196 0.846
removal

Table 2: Distribution of study population according to Systolic blood pressure.

Systolic blood I-Gel Endotracheal tube Mean t-test p-value
pressure Mean SD Mean SD Difference value
At baseline 119.93 5.35 121.07 11.90 -1.13 1.013 0.309
After placement 119.33 5.51 133.47 11.15 -14.13 5.346 0.028*
15 minutes 122.00 5.24 134.27 11.73 -12.27 5.655 0.034*
30 minutes 123.53 5.08 133.27 11.70 -9.73 5.469 0.041*
45 minutes 130.03 5.82 137.73 8.85 -7.70 3.983 0.039*
After Removal 127.53 5.10 129.40 11.87 -1.87 1.091 0.205
5 mins after 122.93 5.07 122.80 11.79 0.13 0.450 0.184

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Table 3: Distribution of study population according to Diastolic blood pressure.
Diastolic blood I-Gel Endotracheal tube Mean t-test p-value
pressure Mean SD Mean SD Difference value
At baseline 79.60 7.19 80.12 6.94 -0.52 1.425 0.160
After placement 79.13 6.94 83.27 7.00 -4.13 2.037 0.039*
15 minutes 82.33 7.07 85.27 7.02 -2.93 2.136 0.026*
30 minutes 82.07 6.76 84.73 7.66 -2.67 2.715 0.048*
45 minutes 82.73 7.04 85.07 4.89 -2.33 2.426 0.037*
After Removal 83.47 5.94 84.33 5.61 -0.87 0.760 0.451
5 minutes after 81.87 5.85 82.73 5.63 -0.87 0.765 0.448
removal

Table 4: Distribution of study population according tomean arterial pressure (MAP)

I-Gel Endotracheal tube Mean t-test p-value
MAP Mean SD Mean SD Difference value
At baseline 93.04 6.65 93.77 6.06 -0.72 0.041 0.968
After placement 92.53 2.72 100.00 2.70 -7.47 2.246 0.035*
15 minutes 95.56 2.22 101.60 2.19 -6.04 2.345 0.024*
30 minutes 95.89 3.19 100.91 4.60 -5.02 2.924 0.037*
45 minutes 98.50 2.65 102.62 3.61 -4.12 2.635 0.031*
After Removal 98.16 3.29 99.36 3.36 -1.20 -0.039 0.969
5 minutes after 95.56 4.05 96.09 4.13 -0.53 -0.032 0.975
removal

Table 5: Distribution of study population according to oxygen saturation(Spo2)

I-Gel Endotracheal tube Mean t-test p-
SpO2 Mean SD Mean SD Difference value value
At baseline 99.60 0.62 99.57 0.63 0.03 0.207 0.837
After placement 99.73 0.58 99.90 0.31 -0.17 -1.387 0.171
15 minutes 99.97 0.18 100.00 0.00 -0.03 -1.000 0.321
30 minutes 99.97 0.18 99.97 0.18 0.00 0.000 1.000
45 minutes 99.40 0.62 99.47 0.68 -0.07 -0.396 0.694
After Removal 100.00 0.00 100.00 0.00 0.00 0.000 1.000
5 minutes after 100.00 0.00 100.00 0.00 0.00 0.000 1.000
removal

Table 6: Distribution of study population according toend tidal carbon dioxide (ETCO2)
I-Gel Endotracheal tube Mean t-test p-value
ETCO2 Mean SD Mean SD Difference value
At baseline 38.93 1.78 38.08 1.53 0.85 1.896 0.225
After placement 37.50 1.76 39.63 1.65 -2.13 -2.848 0.028*
15 minutes 36.83 1.53 37.33 1.32 -0.50 -1.353 0.181
30 minutes 37.13 1.87 37.83 1.72 -0.70 -1.507 0.137
45 minutes 37.83 1.72 37.50 1.76 0.33 0.742 0.461
After Removal 39.63 1.65 38.93 1.78 0.70 1.580 0.120
5 minutes after 39.12 1.89 39.09 1.83 0.03 1.709 0.201
removal

Table 7: Distribution of study population according to Mean leak pressure

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 Mean leak pressure I-Gel Endotracheal Mean t-test p-value
tube Difference value
Mean SD Mean SD

At insertion 15.25 0.16 12.39 0.37 2.86 9.136 0.001*

10 minutes after 15.23 0.15 12.38 0.37 2.86 7.110 0.001*
Pneumoperitoneum
Prior to release of 15.22 0.15 13.06 0.36 2.16 10.344 0.001*
Pneumoperitoneum
After release of 15.21 0.15 14.57 0.60 0.64 1.641 0.461
Pneumoperitoneum

Table 8: Distribution of study population according to complication

Groups p-value
I-Gel Endotracheal tube

Blood staining 3 1 0.048*

10.0% 3.3%
Sore throat 2 4 0.044*
6.7% 13.3%

Discussion
Laparoscopic cholecystectomy is one of the most common procedures performed routinely in surgery.
Endotracheal intubation has been considered as the gold standard technique used to secure the airway during
laparoscopic procedures. Recent literature reveals that supraglottic airway devices, such as I-gel, are also safe for
ventilating and oxygenating lungs during such operations. Regarding the age, sex, height, weight and BMI, the
patients in our study groups were comparable. This was similar to the study by Ahluwalia et al., [12] the age and
gender did not differ between the two groups. Adhikari et al.[13]revealed that there was no statistically difference
between ET tube group and I-gel group regarding age (p-value 0.19), gender (p value 0.77) and American society
of anesthesiologists (ASA) physical status (p-value 0.61). Badhekaet al.[14] stated that no significant difference in
terms of age, weight, height, BMI and duration of surgery were noted. In current study, the mean heart rate after
placement, at 15 minutes and 30 minutes was significantly more among Endotracheal tube group as compared to
the I-Gel group. The mean systolic blood pressure, diastolic blood pressure and MAP after placement, at 15
minutes, 30 minutes and 45 minutes was significantly more among endotracheal tube group compared to the I-
Gel group.
Ahluwalia et al,[12] found that the mean heart rate at T1 immediately following intubation was 74±7.46 compared
to the endotracheal tube group's 80±7.39. Despite the fact that the starting systolic and diastolic pressures in the
two groups were similar. As a consequence, while using an endotracheal tube to intubate a patient, hemodynamic
parameters were significantly different when compared to the i-gel group.
Ahluwalia et al.,[12] observed that EtCO2 were comparable in both groups. During carboperitoneum minute
ventilation was increased mainly by increasing the respiratory rate rather than tidal volume. This was done to
eliminate raised carbon dioxide load and prevent systemic acidosis. Adhikari et al.[13] stated that compared to
baseline data, following the placement of the ET tube, the heart rate, systolic blood pressure, diastolic blood
pressure, and mean arterial pressure all rose. However, in the I-gel group, these values dropped below the baseline
value, which may be related to the activation of vagal fibres during the I-gel insertion. In our study, the mean leak
pressure at insertion, 10 minutes after Pneumoperitoneum and prior to release of Pneumoperitoneum was
significantly more among Endotracheal tube compared to I-Gel.
When choosing SAD for laparoscopic procedures when airway pressure rises owing to pneumoperitoneum,
a high OLP is essential since it ensures an airway without leakage. Yoon et al. [15] underlined that, following
pneumoperitoneum, I gel offers the greatest OLP level. They linked I-medical-grade gel's thermoplastic elastomer
structure, which offers an anatomical seal over pharyngeal tissues, to this benefit. As it changes form in response
to body warmth, it may not initially offer a high OLP but eventually offers a sufficient seal. In a laparoscopic

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cholecystectomy, Sharma et al. [16] investigated the respiratory mechanics of LMA Proseal and I gel. Their findings
indicated that I-gel had higher dynamic compliance and LMA Proseal had higher sealing pressure. Sabuncuet al.
[17]
failed to notice any changes in OLP following pneumoperitoneum in research comparing AuraGain with I-gel
in laparoscopic cholecystectomy. They discovered that the OLP for both SADs was comparable. Gabbottet al.[18]
reached the conclusion that I-gel offers a good airway sealing pressure that improved over time and may be related
to the thermoplastic qualities of the gel cuff, which after warming to body temperature creates an efficient seal
around the larynx.

Complications
Badhekaet al.[14] observed that 2.3% patients had visible blood on I-gel after removal, or 6.6% of the total.
Badhekaet al.[14] observed that 10% of the patients with ETT insertion experienced sore throats, and 10% (3/30)
of the patients experienced damage to their lips, teeth, and gums. I-gel may have a similar airway sealing to that
of PLMA, higher than that of CLMA, and is not related with adverse effects, according to another study conducted
by Shin et al. In comparison to disposable LMAs, the usage of I-gel has now been clinically proven to cause fewer
post-operative sore throat and neck problems.
Massoudet al.[19] found that regarding the prevalence of dysphagia, there was a significant difference between the
I-gel group and the ETT group. In the I-gel group, the incidence was 5%, whereas in the ETT group, it was 40%.
Keijzer et al.,[20] discovered that the incidence of dysphagia with I-gel was 3.7%. Although we did not observe
postoperative dysphonia with I-gel, their investigation found that the incidence of dysphonia was 8.2%.

Conclusion
In terms of hemodynamic stability, airway leak pressures, and post-operative discomfort, I-gel offers a superior,
safe, and dependable alternative to endotracheal intubation in patients undergoing laparoscopic cholecystectomy.
The overall incidence of complications was found to be less with I-Gel than with the traditional endotracheal tube.

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