Evaluation of the efficacy of proseal LMA versus endotracheal intubation for laparoscopic surgeries

Abstract

Open surgeries which were done predominantly in previous days are progressing to minimally invasive keyhole laparoscopic surgeries. In same way, airway management has been also progressed from ETT to lesser invasive Laryngeal Mask Airway (LMA).
This was a prospective observational study which was conducted in patients who came for lower abdominal laparoscopic surgeries during study period of 3 year. All patients were divided into 2 groups with 30 patients in each group (group A- PLMA, group B - ETT). Age, weight, type of surgery, time required for insertion of device, hemodynamic monitoring, ventilatory parameters, postoperative complications in the form of laryngopharyngeal morbidity were recorded.
: In total 60 patients, between the age group of 18-65 year were included which were divided into 2 groups with 30 patients in each group. PLMA required 15.13 seconds as compared to ETT which required 13.33 seconds for insertion of device. The sealing pressure for PLMA was measured by leak test and the average was 32.2 cmH2O. The mean heart rate, systolic BP, Diastolic BP and MAP at various interval was significantly higher in group B as compared to group A (P-value<0.001 for all). The mean ± SD of ETCO2 among the cases studied in Group A and Group B was 36.53 ± 1.87% and 35.13 ± 2.51% respectively. Mean of Peak airway pressure (PAP) among the cases studied in PLMA (Group A) and ETT (Group B) was 22.53 mmHg and 18.97 mmHg respectively No complication or adverse event was noted during post-operative period in PLMA group but in Group ETT, 2 cases were found having blood staining of tube with sore throat in same 2 cases.
PLMA is also proved to be an equally effective airway device in laparoscopic surgeries in the form of adequate oxygenation and ventilation. Also PLMA is associated with minimal intraoperative and postoperative complications. PLMA provided equally effective pulmonary ventilation despite of high airway pressures without significant gastric distension, aspiration and regurgitation.

Full text

Indian Journal of Clinical Anaesthesia 2020;7(2):285–289
Content available at: iponlinejournal.com
Indian Journal of Clinical Anaesthesia
Journal homepage: www.innovativepublication.com
Original Research Article
Evaluation of the efficacy of proseal LMA versus endotracheal intubation for
laparoscopic surgeries
Sheela Bhagwat Lawate1, Varshali M Keniya1,*, Sarita S Swami1
1Dept. of Anaesthesia, Bharati Vidyapeeth (Deemed to be) University Medical College, Pune, Maharashtra, India
ARTICLE INFO
Article history:
Received 20-12-2019
Accepted 17-01-2020
Available online 03-06-2020
Keywords:
Proseal laryngeal mask airway
(PLMA)
Endotracheal tube (ETT)
Oropharyngeal leak pressure (OLP)
Laparoscopy
ABSTRACT
Background: Open surgeries which were done predominantly in previous days are progressing to
minimally invasive keyhole laparoscopic surgeries. In same way, airway management has been also
progressed from ETT to lesser invasive Laryngeal Mask Airway (LMA).
Materials and Methods: This was a prospective observational study which was conducted in patients
who came for lower abdominal laparoscopic surgeries during study period of 3 year. All patients were
divided into 2 groups with 30 patients in each group (group A- PLMA, group B - ETT). Age, weight,
type of surgery, time required for insertion of device, hemodynamic monitoring, ventilatory parameters,
postoperative complications in the form of laryngopharyngeal morbidity were recorded.
Results: In total 60 patients, between the age group of 18-65 year were included which were divided into 2
groups with 30 patients in each group. PLMA required 15.13 seconds as compared to ETT which required
13.33 seconds for insertion of device. The sealing pressure for PLMA was measured by leak test and the
average was 32.2 cmH2O. The mean heart rate, systolic BP, Diastolic BP and MAP at various interval was
significantly higher in group B as compared to group A (P-value<0.001 for all). The mean ±SD of ETCO2
among the cases studied in Group A and Group B was 36.53 ±1.87% and 35.13 ±2.51% respectively.
Mean of Peak airway pressure (PAP) among the cases studied in PLMA (Group A) and ETT (Group B)
was 22.53 mmHg and 18.97 mmHg respectively No complication or adverse event was noted during post-
operative period in PLMA group but in Group ETT, 2 cases were found having blood staining of tube with
sore throat in same 2 cases.
Conclusion: PLMA is also proved to be an equally effective airway device in laparoscopic surgeries in
the form of adequate oxygenation and ventilation. Also PLMA is associated with minimal intraoperative
and postoperative complications. PLMA provided equally effective pulmonary ventilation despite of high
airway pressures without significant gastric distension, aspiration and regurgitation.
© 2020 Published by Innovative Publication. This is an open access article under the CC BY-NC license
(https://creativecommons.org/licenses/by-nc/4.0/)
1. Introduction
Open surgeries which were done predominantly in previous
days are progressing to minimally invasive keyhole
laparoscopic surgeries. In same way, airway management
has been also progressed from ETT to lesser invasive
Laryngeal Mask Airway (LMA).1In airway management,
the use of supraglottic airway devices have become standard
and filling a niche between facemask and tracheal tube
in terms of both anatomical position and degree of
* Corresponding author.
E-mail address: varshkeniya@yahoo.com (V. M. Keniya).
invasiveness. These devices provide hands free means to
achieve a gas tight airway. The first successful supraglottic
airway device, the laryngeal mask airway (LMA) classic
became available in 1989, first described by Archie Brain.
Second generation supraglottic airway that is Proseal LMA
with high seal pressure, has become the benchmark device.
Proseal LMA (PLMA) forms a more effective seal than the
LMA and has a drainage tube that facilitates passage of
gastric tube. LMA once it is correctly placed, it provides the
protection against regurgitation as well as prevents gastric
insufflation.2This study was undertaken to evaluate the
efficacy of Proseal LMA versus endotracheal intubation for
https://doi.org/10.18231/j.ijca.2020.051
2394-4781/© 2020 Innovative Publication, All rights reserved. 285

286 Lawate, Keniya and Swami / Indian Journal of Clinical Anaesthesia 2020;7(2):285–289
laparoscopic surgery in selected cases.
2. Materials and Methods
This was a prospective comparative study done in tertiary
care center in a teaching institute in Pune after taking
approval from ethical committee and included all patients
undergoing laparoscopic surgeries, in age group of 18-
65 year with ASA I & II grading and BMI less than
<35kg/m2. The written informed consent was taken from
all patients. The patients with anticipated difficult airway,
those with risk of aspiration and those with oropharyngeal
pathology were excluded from study. The preanesthetic
checkup was done in detail one day prior to surgery. All
the standard monitors were attached. Induction was done
with inj. Fentanyl and inj. Propofol. Appropriate size device
was inserted in patients undergoing laparoscopic surgeries.
The maintenance of anesthesia with O2 & sevoflurane
and muscle relaxant used was inj. rocuronium. The
intraoperative parameters like Heart rate, SBP, DBP, MAP,
SPO2, ETCO2, PAW, sealing pressure and postoperative
complications like blood staining of device, sore throat
and spasm were noted. Correct placement of Proseal LMA
was confirmed by- Adequate chest movement on manual
ventilation, Square wave capnography, Expired tidal volume
of more than 8ml/kg, gas bubble test and Pressure leak test.
Any cross over to endotracheal tube during intraoperative
events were noted in case of improper placement of PLMA,
inadequate seal or unsatisfactory ventilation.
2.1. Statistical data analysis
The data on categorial variables is shown as n (% of
cases) and the data on normally distributed continuous
variables is presented as mean and standard deviation
(SD) across two study groups. The inter-group statistical
comparison of distribution of categorical variables is tested
using Chi-Square test or Fisher’s exact probability test. The
inter-group statistical comparison of normally distributed
variables is done using independent sample t test. In the
entire study, the p-value less than 0.05 are considered to be
statistically significant.
3. Results
In total 60 patients were included which were divided into 2
groups as group A and Group B.
The mean age in group A and B were 32.64 year and
37.5 year respectively. Weight of patients in both the groups
was (mean) 58 kg and 60.47kg respectively. Maximum and
minimum Duration of surgery in both group A and B was
1-3.83 hrs. and 1-3.75hrs.
The minimum – maximum time taken for insertion of
device range in Group A and Group B was 10 – 20 Seconds
and 10 – 18 Seconds respectively. The mean ±SD of time
taken for insertion of device among the cases studied in
Group A and Group B was 15.13 ±2.53 Seconds and 13.33
±2.66 Seconds respectively.
In our study, sealing pressure for PLMA was measured
by leak test and the average was 32.2 cmH2O.
The mean heart rate at 1-Min, 5-Min, 15-Min, 30-Min,
2-Hr, 3-Hr and after removal of device among the cases is
significantly higher in Group B compared to Group A (P-
value<0.001 for all). In the same way, mean systolic BP
and Diastolic BP at 1-min, 5-min, 30-min, 1-hr, 2-hr, 3-
hr and after removal of device among the cases studied is
significantly higher in Group B compared to Group A (P-
value<0.05 for all). Distribution of mean MAP among the
cases studied at 1-min, 5-min 30-min, 1-hr and after removal
of device is significantly higher in Group B compared to
Group A (P-value<0.05 for all).
The mean ±SD of ETCO2 among the cases studied in
Group A and Group B was 36.53 ±1.87% and 35.13 ±
2.51% respectively. The minimum – maximum respiratory
rate range in Group A and Group B was 12 – 15 per min and
11 – 15 per min respectively.
The minimum – maximum PAP range in Group A
and Group B was 17 – 27 mmHg and 13 – 25 mmHg
respectively. The mean ±SD of PAP among the cases
studied in Group A and Group B was 22.53 ±2.69 mmHg
and 18.97 ±2.71 mmHg respectively.
Of 30 cases studied in Group A, none had incidence of
blood staining of device and sore throat. Of 30 cases studied
in Group B, 2 (6.7%) had incidence of blood staining of
device and sore throat.
4. Discussion
There are many developments for minimal invasive surgery
which has revolutionized surgical procedures and that
has influenced the practice of anesthesiology. Although
there are many advantages of Laparoscopic procedures,
there are disadvantages as well, like the physiological
hemodynamic changes and life-threatening complications
such as regurgitation of the gastric contents and potential
aspiration due to physiological changes associated with
pneumoperitoneum.In view of this, ETT is considered to
be gold standard in laparoscopic surgeries to achieve a
safe glottic seal. But, for laparoscopic surgeries, anesthetic
techniques and airway management have been refined in
anticipation of various differences from open surgery.1
The PLMA is a recent advancement in the family of
LMA with some added features over the classic LMA. The
design of PLMA with better seal and inclusion of drain
tube, makes it a choice of SAD to be used for laparoscopic
surgery.2
In our prospective comparative study, 60 patients
between age of 18-65 years of ASA I and ASA II category
were posted for laparoscopic surgeries under controlled ven-
tilation in various surgeries like appendicectomy, umbilical
hernia repair, inguinal hernia repair, etc. 60 patients were

Lawate, Keniya and Swami / Indian Journal of Clinical Anaesthesia 2020;7(2):285–289 287
Table 1: Inter-group comparison of mean PAP
PAP (mmHg) Group A (n=30) Group B (n=30) P-value
Mean SD Mean SD
PAP (mmHg) 22.53 2.69 18.97 2.71 0.001***
Values are mean and SD, P-value by independent sample t test. P-value<0.05 is considered to be statistically significant. ***P-value<0.001.
divided into two groups, PLMA (group A) and ETT (group
B), each group included 30 patients. The hemodynamic
parameters, ventilatory efficacy as well as adverse effects
were monitored in two groups. We chose PLMA as SAD
because in previous studies, it has been proved that, for
adequate pulmonary ventilation in case of increased intra-
abdominal pressure from pneumoperitoneum which require
higher airways pressures, there PLMA is proved to be
device of choice amongst SADs.
Size of sample, Age, gender, weight and ASA grading
when compared in two groups, no statistical difference
was seen between two groups. PLMA insertion took 15.13
seconds compared to 13.33 seconds for the traditional ETT
insertion. The distribution of mean time taken for insertion
of device among the patients studied is statistically higher
in group A compared to group B. (p value <0.01). This may
be because of larger cuff size of PLMA which may require
more time to inflate the cuff.
PLMA cuff pressure measurement done by using cuff
pressure manometer and it was maintained within normal
range throughout the surgery time. The double cuff
arrangement of PLMA prevent the chances of aspiration.
Nasogastric tube was inserted in all our cases after
confirming that there was no evidence of leak via the drain
tube.
In our study, there was rise in heart rate in both the
groups from baseline, during insertion and extubation. The
change was statistically highly significant. The magnitude
and duration of increase in Heart Rate was more seen in
group B than in group A, as shown in Figure 1.Similar
results were seen in study done by, Dr S Vinodkumar and Dr.
M Vijayasankar, in 2019.They monitored, HR, SBP, DBP,
MAP before induction and 1 min, 5 min after intubation,
then 5 min after pneumoperitoneum, and every 5min till
end of surgery and 5 min after Extubation, and compared
between Group I (ETT) and Group II (PLMA). They found
that all the parameters are high at the every points mentioned
above and concluded that PLMA is hemodynamically more
stable than ETT in laparoscopic surgeries. Our observations
were comparable with this study.3
Opposed to this findings, Patel et al in 2010 found that
there was no change in haemodynamic parameter during
insertion and removal of device in the proseal LMA group
patients.4
In our study, there was rise in SBP, DBP and MAP after
1min, 5min, 30min and after removal of device in both
groups but it was significant in ETT group as compared to
Fig. 1: Inter-group comparison of mean heart rate
PLMA group, as shown in Figures 2, 3 and 4. The findings
in our study were comparable with the study done by Fujii et
al., Shahin et al, Garima Agarwal. They found that there was
a sustained and significant rise in mean BP in ETT group at
3min post insertion while it came to baseline value at 5min
in PLMA group.5–7
Fig. 2: Inter-group comparison of mean systolic BP
Fig. 3: Inter-group comparison of mean diastolic BP
Opposed to these findings, the study done by Lalwani
et al (2010) regarding the use of PLMA as an alternative
to ETT in paediatric patients. They found that SBP was
increased from baseline after insertion of PLMA or ETT and
that was statistically insignificant (p>0.05) in both groups.8
In our study, the minimum –maximum ETCO2 range
in PLMA and ETT group was 34-40% and 30-39%
respectively. The distribution of mean ETCO2 among

288 Lawate, Keniya and Swami / Indian Journal of Clinical Anaesthesia 2020;7(2):285–289
Fig. 4: Inter-group comparison of mean MAP
the cases studied is significantly higher in group PLMA
compared to ETT group (p value<0.05) but it was
within acceptable limit.Dave et al evaluated the Proseal
LMA as a device for airway management in patients
undergoing laparoscopic Surgery and they noted that
only two patients PLMA was replaced by ETT in view
of increase in ETCO2.9To achieve the normocapnia,
ventilatory parameters designed and the PLMA afford
adequate and safe glottic seal. The distribution of RR and
FiCO2 did not differ significantly in our study and RR was
adjusted according to the ETCO2 levels.
In our study, the mean of Peak airway pressure (PAP)
among the cases studied in PLMA (Group A) and ETT
(Group B) was 22.53 mmHg and 18.97 mmHg respectively.
The distribution of mean PAP among the cases studied is
significantly higher in Group A compared to Group B (P-
value<0.001) but this was within the acceptable limits as
shown in Table 1.
In our study, sealing pressure was measured by leak
test and the average was 32.2 cmH2O. The intraabdominal
pressure after pneumoperitoneum was kept in range of
12- 14cmh2o. The Peak Airway Pressures never crossed
the sealing pressure. In the study done by Mishra et
al. in 2015, evaluated the effect of pneumoperitoneum
and the trendelenburg position on Oropharyngeal Seal
pressure in patients undergoing laparoscopic gynecological
surgery. He observed that there is a significant increase
in Oropharyngeal Seal Pressure after the creation of
pneumoperitoneum compared with their baseline values.
They concluded that it may be because of the increase in
intra-abdominal pressure leading to upward movement of
trachea, in an LMA which is already placed and fixed.10
In our study, of 30 cases in group PLMA, none had
incidence of sore throat. Of 30 cases studied in group ETT,
two cases (6.7%) had incidence of sore throat and blood
staining of device way Pressures never crossed the sealing
pressure. Patel MG et al compared the effect of PLMA and
ETT in 60 patients of ASA I/II grading undergoing elective
lower abdominal surgical procedure, which were divided
equally into two groups. Haemodynamic parameters were
monitored like heart rate, SBP, DBP, SPO2 and EtCO2.
In his study, in postoperative period, 40% of patients had
coughing and 13.33% had sore throat.4
Shroff et al and Higgins et al also found the there
was higher incidence of sore throat in patients undergoing
endotracheal intubation than in those in whom PLMA was
used.11,12 The absence of sore throat in PLMA group can
be explained by the fact that it is a supraglottic device and
mucosal pressure achieved are usually below pharyngeal
perfusion pressure.13
Even though the endo-tracheal intubation is the gold
standard in laparoscopic surgeries done under GA, the
PLMA proved to provide the equally effective oxygenation
and ventilation. The haemodynamic stress response was
minimal with PLMA as compared to endotracheal
intubation. Also the intraoperative and postoperative
complications are less with PLMA group. Despite of
high airway pressures, PLMA provided equally effective
pulmonary ventilation which was not associated with
significant gastric distension, aspiration and regurgitation.
5. Conclusion
PLMA provided equally effective pulmonary ventilation
despite of high airway pressures without significant gastric
distension, aspiration and regurgitation. In comparison to
PLMA, the haemodynamic parameters after insertion of
ETT reveal significant increase in stress response. PLMA is
comparable with ETT in laparoscopic surgeries in securing
a patent airway during controlled ventilation.
Thus, PLMA is safe and effective alternative to
endotracheal intubation in patients undergoing laparoscopic
surgeries.
6. Source of Funding
None.
7. Conflict of Interest
None.
References
1. Shroff P, Surekha K. Randomized comparative study between
the proseal laryngeal mask airway and the endotracheal tube for
laparoscopic surgery. Internet J Anesthesiol. 2006;p. 11.
2. Saraswat N, Kumar A, Mishra A, Gupta A, Saurabh G, Srivastava U.
The comparison of Proseal laryngeal mask airway and endotracheal
tube in patients undergoing laparoscopic surgeries under general
anaesthesia. Indian J Anaesth. 2011;55:129.
3. Vinodhkumar S, Vijayasankar M. Comparison of proseal laryngeal
mask airway vs endotracheal tube for laparoscopic surgery. Indian J
Appl Res. 2019;9(3).
4. Patel MG, Swadia VN, Bansal G. Prospective randomized
comparative study of use of PLMA and ET tube for airway
management in children under general anaesthesia. Indian J Anaesth.
2010;54(2):109.
5. Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Retracted Article:
Cardiovascular responses to tracheal extubation or LMA removal in
children. Can J Anesth. 1998;45(2):178–81.
6. Jamil SN, Alam M, Usmani H, Khan MM. A study of the use of
laryngeal mask airway (LMA) in children and its comparison with
endotracheal intubation. Indian J Anaesth. 2009;53(2):174.

Lawate, Keniya and Swami / Indian Journal of Clinical Anaesthesia 2020;7(2):285–289 289
7. Agrawal G, Taneja S, Agarwal M. A randomized comparative study
of intraocular pressure and hemodynamic changes on insertion of
proseal laryngeal mask airway and conventional tracheal intubation
in pediatric patients. J Anaesthesiol Clin Pharmacol. 2012;28(3):326.
8. Lalwani J, Dubey KP, Sahu BS, Shah PJ. ProSeal laryngeal mask
airway: An alternative to endotracheal intubation in paediatric patients
for short duration surgical procedures. Indian J Anaesth. 2010;54:541.
9. Dave NM, Iyer HR, Dudhedia U, Makwana J. An evaluation of
the ProSeal laryngeal mask airway in paediatric laparoscopy. J
Anaesthesiol Clin Pharmacol. 2009;25(1):71.
10. Mishra S, Sivaraman B, Balachander H, Naggappa M, Parida S, Bhat
R, et al. Effect of pneumoperitoneum and Trendelenberg position
on oropharyngeal sealing pressure of I-gelTMand ProSeal LMATM
in laparoscopic gynecological surgery: A randomized controlled trial.
Anesth: Essays Res. 2015;9:353.
11. Shroff P, Surekha K. Randomized comparative study between
the proseal laryngeal mask airway and the endotracheal tube for
laparoscopic surgery. Internet J Anesthesiol. 2006;p. 11.
12. Higgins PP, Chung F, Mezei G. Postoperative sore throat after
ambulatory surgery. Br J Anaesth. 2002;88:582–4.
13. Rabey PG, Murphy PJ, Langton JA, Barker P, Rowbotham DJ. Effect
of the laryngeal mask airway on lower oesophageal sphincter pressure
in patients during general anaesthesia. Br J Anaesth. 1992;69(4):346–
8.
Author biography
Sheela Bhagwat Lawate Junior Resident 3rd
Varshali M Keniya Associate Professor
Sarita S Swami Professor and HOD
Cite this article: Lawate SB, Keniya VM, Swami SS. Evaluation of the
efficacy of proseal LMA versus endotracheal intubation for
laparoscopic surgeries. Indian J Clin Anaesth 2020;7(2):285-289.