The comparison of ProSeal laryngeal mask airway and endotracheal tube in patients undergoing laparoscopic surgeries under general anaesthesia

Abstract

Aims to compare the efficacy of Proseal laryngeal mask airway(PLMA) and endotracheal tube (ETT) in patients undergoing laparoscopic surgeries under general anaesthesia. This prospective randomised study was conducted on 60 adult patients, 30 each in two groups, of ASA I-II who were posted for laparoscopic procedures under general anaesthesia. After preoxygenation, anaesthesia was induced with propofol, fentanyl and vecuronium. PLMA or ETT was inserted and cuff inflated. Nasogastric tube (NGT) was passed in all patients. Anaesthesia was maintained with N(2) O, O(2), halothane and vecuronium. Ventilation was set at 8 ml/kg and respiratory rate of 12/min. The attempts and time taken for insertion of devices, haemodynamic changes, oxygenation, ventilation and intraoperative and postoperative laryngopharyngeal morbidity (LPM) were noted. There was no failed insertion of devices. Time taken for successful passage of NGT was 9.77 s (6-16 s) and 11.5 s (8-17 s) for groups P and E, respectively. There were no statistically significant differences in oxygen saturation (SpO(2)) or end-tidal carbon dioxide (EtCO(2)) between the two groups before or during peritoneal insufflation. Median (range) airway pressure at which oropharyngeal leak occurred during the leak test with PLMA was 35 (24-40) cm of H(2)O. There was no case of inadequate ventilation, regurgitation, or aspiration recorded. No significant difference in laryngopharyngeal morbidity was noted. A properly positionedPLMA proved to be a suitable and safe alternative to ETT for airway management in elective fasted, adult patients undergoing laparoscopic surgeries. It provided equally effective pulmonary ventilation despite high airway pressures without gastric distention, regurgitation, and aspiration.

Full text

129
Indian Journal of Anaesthesia | Vol. 55| Issue 2 | Mar-Apr 2011
The comparison of Proseal laryngeal mask airway
and endotracheal tube in patients undergoing
laparoscopic surgeries under general anaesthesia
Namita Saraswat, Aditya Kumar1, Abhijeet Mishra2, Amrita Gupta1, Gyan Saurabh3,
Uma Srivastava1
Departments of Anaesthesia and 3Surgery, Lady Hardinge Medical College, New Delhi, 1Department of
Anaesthesia, S.N. Medical College, Agra and 2RML Hospital, New Delhi, India
How to cite this article: 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;55:129-34.
ABSTRACT
Aims to compare the efcacy of Proseal laryngeal mask airway (PLMA) and endotracheal tube
(ETT) in patients undergoing laparoscopic surgeries under general anaesthesia. This prospective
randomised study was conducted on 60 adult patients, 30 each in two groups, of ASA I-II who were
posted for laparoscopic procedures under general anaesthesia. After preoxygenation, anaesthesia
was induced with propofol, fentanyl and vecuronium. PLMA or ETT was inserted and cuff inated.
Nasogastric tube (NGT) was passed in all patients. Anaesthesia was maintained with N2O, O2,
halothane and vecuronium. Ventilation was set at 8 ml/kg and respiratory rate of 12/min. The
attempts and time taken for insertion of devices, haemodynamic changes, oxygenation, ventilation
and intraoperative and postoperative laryngopharyngeal morbidity (LPM) were noted. There was
no failed insertion of devices. Time taken for successful passage of NGT was 9.77 s (6-16 s) and
11.5 s (8-17 s) for groups P and E, respectively. There were no statistically signicant differences
in oxygen saturation (SpO2) or end-tidal carbon dioxide (EtCO2) between the two groups before or
during peritoneal insufation. Median (range) airway pressure at which oropharyngeal leak occurred
during the leak test with PLMA was 35 (24-40) cm of H2O. There was no case of inadequate
ventilation, regurgitation, or aspiration recorded. No signicant difference in laryngopharyngeal
morbidity was noted. A properly positioned PLMA proved to be a suitable and safe alternative to
ETT for airway management in elective fasted, adult patients undergoing laparoscopic surgeries.
It provided equally effective pulmonary ventilation despite high airway pressures without gastric
distention, regurgitation, and aspiration.
Key words: Endotracheal tube, IPPV, laparoscopy, oropharyngeal seal pressure, Proseal LMA
Address for correspondence:
Dr. Namita Saraswat,
Department of Anaesthesia,
Lady Hardinge Medical
College, New Delhi, India.
E-mail: namita_saraswat@
yahoo.com
INTRODUCTION
In spite of tremendous advances in contemporary
anaesthetic practice, advances, airway management
continues to be of paramount importance to
anaesthesiologists. Till date, the cuffed tracheal tube
was considered as the gold standard for providing a
safe glottic seal, especially for laparoscopic procedures
under general anaesthesia.[1] The disadvantages of
tracheal intubation, which involves rigid laryngoscopy,
are in terms of concomitant haemodynamic responses
and damage to the oropharyngeal structures at
insertion. Postoperative sore throat is also a serious
concern. This precludes the global utility of the
tracheal tube and requires a better alternative.[2] Over
a period of time, new airway devices have been added
to the anaesthesiologist’s armamentarium.
Proseal laryngeal mask airway (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
Access this article online
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DOI: 10.4103/0019-5049.79891
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Saraswat, et al.: Proseal LMA vs endotracheal tube in laparoscopic surgeries
pressures without leak. The drain tube parallel to
the ventilation tube permits drainage of passively
regurgitated gastric fluid away from the airway and
serves as a passage for gastric tube.[2] The PLMA is a
relatively new airway device in developing nations.
This study is therefore undertaken to compare PLMA
with standard tracheal tube for the number of attempts
and time taken for insertion, haemodynamic changes,
oxygenation, ventilation and intraoperative and
postoperative laryngopharyngeal morbidity (LPM)
occurring during general anaesthesia in young healthy
adult patients undergoing laparoscopic surgeries.
METHODS
After obtaining the Ethics committee approval and
written informed consent, this prospective randomised
study was conducted on 60 healthy patients. The
patients were of either sex belonging to ASA physical
status grade I and II, aged 20-65 years and body weight
40-76 kg, who underwent laparoscopic procedures
under general anaesthesia. Patients with anticipated
difficult airway, obesity (body mass index > 35 kg/m2),
oropharyngeal pathology, cardiopulmonary disease,
cervical spine fracture or instability, or at increased
risk of aspiration (gastro-esophageal reflux disease,
hiatus hernia, and pregnant patients) were excluded
from the study.
Patients were randomised for airway management
with the PLMA or endotracheal tube (ETT) by
opening an opaque envelope inside the operation
theatre containing the computer-generated random
assignment into two groups of 30 each. Patients in
group P were to receive a PLMA and patients in group
E were to undergo endotracheal intubation. Patients
were premedicated with oral alprazolam 0.5 mg the
night before surgery and on the day of surgery. After
intravenous (IV) access was obtained, ranitidine 50
mg and metoclopramide 10 mg were administered
30 minutes before surgery. In the operation theatre,
standard monitors were attached and baseline
parameters were recorded. Injections of midazolam
0.02 mg/kg, glycopyrrolate 0.005 mg/kg, and fentanyl
1-2 µg/kg were administered 1-2 min before induction.
After preoxygenation with 100% O2 for 3-5 minutes,
anaesthesia was induced with injection of propofol
2-2.5 mg/kg till the loss of verbal commands.
Neuromuscular blockade to facilitate placement of
device was achieved by vecuronium 0.08-0.1 mg/
kg. Following induction and adequate paralysis, the
corresponding airway was inserted in each group. The
airway devices were inserted by anaesthesiologists
with at least 1 year experience with PLMA and ETT.
In group P, size 3 or 4 PLMA (according to weight)
was used. For the purpose of standardisation, we used
the introducer for inserting the PLMA for all cases
as recommended by the manufacturer. In group E,
endotracheal intubation (7.5 in females and 8 in males)
was performed in standard manner. The time interval
between holding the airway device to confirmation
of correct placement by bilateral air entry on chest
auscultation was noted.
Correct placement of the devices was confirmed by:
• Adequate chest movement on manual ventilation
• Square wave capnography
• Expired tidal volume of more than 8 ml/kg
• No audible leak from the drain tube with peak
airway pressure (PAP) less than 20 cm H2O. A leak
below 20 cm H2O was taken as significant and
suggested a malposition
• The gel displacement test, done by placing a blob
of gel at the tip of the drain tube (DT) and noting
the airway pressure at which it was ejected
The last two tests were specific for group P.
Anaesthesia was maintained with oxygen, nitrous
oxide, halothane, and vecuronium.
The outcomes measured were as follows:
• Insertion characteristics of the PLMA or ETT and
the nasogastric tube (NGT) via the PLMA and the
ETT (NGT was introduced in all cases).
• Easy insertion – insertion at first attempt with
no resistance; difficult insertion –insertion with
resistance or at second attempt; and failed insertion
– insertion not possible.
• Haemodynamic responses (heart rate and mean
arterial blood pressure) were recorded before
induction; at the time of insertion; 1 and 3, 5
min after insertion of device; after achieving
carboperitoneum, and during removal of devices.
• Oxygen saturation (SpO2) and end-tidal carbon
dioxide (EtCO2); at a tidal volume of 8 ml/kg,
fraction of inspired oxygen (FiO2) 0.33, respiratory
rate of 12/min and I/E of 1:2 were recorded.
• The aim was to maintain target SpO2 (>95%)
and EtCO2 (<45 mm Hg) by adjusting the FiO2,
respiratory rate and tidal volume. When SpO2 was
94-90% the oxygenation was graded as suboptimal
and failed if it was <90%.
• Oropharyngeal seal pressure was determined by
closing the expiratory valve at a fixed gas flow of 5
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131
Indian Journal of Anaesthesia | Vol. 55| Issue 2 | Mar-Apr 2011
Saraswat, et al.: Proseal LMA vs endotracheal tube in laparoscopic surgeries
l/min and recording the airway pressure at which
equilibrium was reached. The airway pressure was
not allowed to exceed 40 cm H2O.
• The PAP was recorded when intra-abdominal pressure
(IAP) reached 16 mm Hg. For standardisation, IAP
was maintained at 12-16 mm Hg.
• Incidences of gastric distension (by surgeon),
regurgitation, aspiration, intraoperative and
postoperative laryngopharyngeal morbidity were
noted.
Statistical analysis
Data were analysed using INSTAT 3 (GraphPad Software,
California, USA). The primary variables studied were
oxygenation and adequacy of ventilation. Secondary
variables were time to achieve an effective airway, airway
interventions required, haemodynamic parameters,
cuff leak pressure, and PAP. Sample size of 60, with
30 patients in each group was determined for primary
variables (O2 saturation and EtCO2), using the following
information from various previous studies: standard
deviations of 5% and 5 mm Hg for the two variables,
respectively, were considered statistically significant.
If the statistically significant difference in a decrease in
oxygen saturation was less than 95% for one of the devices,
it was considered to be clinically significant. Sample
size was calculated assuming a two-sided test with
α = 0.05 and the power of 0.9. Two-sided independent
Student’s t tests to analyse continuous data, and Fisher’s
exact test for categorical data. P<0.05 was considered as
significant.
RESULTS
The surgical procedures, patient characteristics and
details of anaesthesia and airway management are
shown in Figure 1. Demographic data were comparable
in both groups.
Size 3 PLMA placement was attempted in 19 patients,
size 4 in 11 patients [Table 1]. Insertion success rate
was 86.67% for the first attempt, and two attempts
were made in 13.33% patients. Insertion was easy
in 23 and difficult in 7 patients. In Group E, the
insertion success rate was 83.37% for the first attempt;
two attempts were made in 13.33% of patients and
third attempt was required in 3.33% patients. There
was no failed insertion reported in either group.
Mean time (range) taken for successful placement was
15.77 s (12-21 s) and 16.93 s (11-28 s) for PLMA and
ETT, respectively.
Time taken for successful passage of NGT was 9.77
s (6-16 s) and 11.5 s (8-17 s) for P and E groups,
respectively.
On comparing the trends within groups statistically
significant (P<0.05) increase in heart rate and the
mean blood pressure was observed 10 seconds
after intubation and persisted till 3 minutes after
intubation and during the time of extubation in
the ETT group. However, statistically significant
(P<0.05) increase in the heart rate and mean blood
pressure in PLMA group was seen only 10 seconds
after insertion [Figure 2].
The EtCO2 was comparable in both groups throughout
the surgery (P>0.05) and did not increase beyond
45 mm Hg.
The PAP in group P showed a statistically significant
(P<0.05) increase in value after insertion till 6 minutes
after pneumoperitoneum was attained, and thereafter
it was insignificant.
Figure 1: Demographic data and type of procedures done
Table 1: Details of airway management
Airway device details PLMA ETT P value
Size of device (3/4,7.5/8) 19/11 23/7
Attempt of insertion (1/2/3/
failed)
26/4/0/0 25/4/1/0
Time taken for insertion of
device, Mean (SD)
15.77 (2.97) 16.93 (4.07) 0.209
Attempts at gastric tube
insertion (1/2/3/failed)
27/3/0/0 20/7/3/0
Time taken for insertion of
gastric tube, Mean (SD)
9.77 (2.44) 11.5 (2.28) 0.006
Oropharyngeal seal
pressure, Median
35 cm of
H2O
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Saraswat, et al.: Proseal LMA vs endotracheal tube in laparoscopic surgeries
Both groups maintained oxygen saturation
perioperatively except in one patient in the PLMA
group where oxygen saturation dropped to 94%
(suboptimal oxygenation) after placing patients in
the reverse Trendelenburg position. The oxygen
saturation returned to normal after the PLMA was
repositioned.
Oropharyngeal seal pressure for PLMA group observed
was 35 mm Hg (median), with no clinically audible
leak throughout the surgery. The PAP, however, did
not increase beyond the oropharyngeal seal pressure
in the PLMA group [Table 1].
In the present study, coughing after removal of PLMA
was seen in 6.67% patients, while it was seen in
3.33% patients in the ETT group. Blood staining of
device on removal was seen in 10% patients in group
P and in 16.67% patients in group E. Minor trauma
to the lip and gums was seen in 1 patient (3.33%) in
group E. There was no incidence of intraoperative or
postoperative laryngospasm, bronchospasm, in either
group. There was no incidence of regurgitation or
clinically detectable pulmonary aspiration in either
group [Table 2]. In 3 patients, gastric distention was
successfully decompressed via NGT suction. Sore
throat postoperatively was seen in 10% patients in
group P and in 20% patients in group E. After 24
hours, no patient in group P but 2 patients (6.67%) in
E group complained of sore throat.
DISCUSSION
The PLMA is a new entrant to the family of LMA
with some added features over the classic LMA.[3]
This study was conducted with the aim of comparing
PLMA and ETT as a ventilatory device in 60 patients
undergoing laparoscopic surgeries. We chose this study
because increased intra-abdominal pressure from
pneumoperitoneum requires higher airway pressures
for adequate pulmonary ventilation, for which the
PLMA has proved to be adequate in previous[1,2,4] studies.
Although PLMA was easier to insert with higher success
rate (86.67%) in the first attempt than the ETT (83.33%),
this was not statistically significant. Mean time taken
for successful placement was 15.77 s and 16.93 s for
groups P and E, respectively. Studies by Cook, Shroff
and coworkers (median effective time 15 s) corroborated
with our study findings.[4,5] Sharma and coworkers,
in their study of 100 and 1,000 PLMA insertions,
reported a mean insertion time of 13.51 s and 12 s,
respectively.[1,6] This lesser time could be attributed to the
fact that their study was conducted by anaesthesiologists
who had more experience in working with PLMA.
A NGT was inserted in all patients. The mean insertion
time taken to insert NGT through PLMA was significantly
less (9.77 s) than via nose (11.5 s) in intubated patients.
Similarly, the success rate of NGT in the first attempt
was higher (90%) via Proseal than via nasal route in
intubated patients (66.67%). These factors may be of
clinical relevance in patients with hypertension, head
injury, and ischaemic heart disease.
There was minimum haemodynamic stress response
with PLMA when compared with endotracheal
intubation. These findings are similar to those of
previous studies.[1,2,7]
Figure 2: Haemodynamic parameters
Statistically signicant increase in heart rate and mean blood pressure
was observed 10 seconds after intubation and persisted till 3 minutes
after intubation and also during extubation in the ETT group. However,
statistically signicant increase in Proseal-LMA group was seen only
10 seconds after insertion.
Table 2: Laryngopharyngeal morbidity
PLMA ETT P
Intraoperative
1. Leak 1 -
2. Gastric insufation 3 -
3. Regurgitation, aspiration - -
At removal
1. Coughing 2 1 0.556
2. Blood staining of device 3 5 0.45
3. Trauma to lip, teeth, tongue 4 1 0.17
Postoperative
1. Vomiting - -
2. Sore throat 3 7 0.171
3. Dysphagia, dysphonia, dysarthia - -
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Saraswat, et al.: Proseal LMA vs endotracheal tube in laparoscopic surgeries
The increase in heart rate during intubation is attributed
to sympathetic stimulation during laryngoscopy
and the passage of the ETT through the vocal
cords.[1,8,9] The PLMA being a supraglottic device does
not require laryngoscopy and probably does not evoke
a significant sympathetic response. Attenuation of this
response may be due to diminished catecholamine
release.[10] This could be due to the fact that the PLMA
is relatively simple and atraumatic to insert and does
not require laryngoscopy.[9]
Following peritoneal insufflation, CO2 is absorbed
transperitoneally, and the rate at which this occurs
depends on gas solubility, perfusion of the peritoneal
cavity, and duration of the pneumoperitoneum.[11]
Both groups maintained adequate oxygenation and
ventilation perioperatively, except in one patient in
the PLMA group, where oxygen saturation dropped to
94% (suboptimal oxygenation) after placing the patient
in reverse Trendelenburg position. We repositioned
the PLMA and oxygen saturation returned to normal
thereafter.
Maltby et al. and Sharma et al. found no statistically
significant differences in SpO2 or EtCO2 between
the two groups before or during peritoneal
insufflations.[7,11]
However, Sharma and colleagues in a later study noted
that although all patients had optimal oxygenation,
three patients had EtCO2 in excess of 55 mm Hg after
CO2 insufflation.[6] This was explained by the fact
that the airway tube was narrow and the epiglottis
downfolded in some patients. The incidence of
epiglottic downfolding has been reported to be as high
as 31-66%.[12]
The observed oropharyngeal seal pressure for PLMA
group was 35 mm Hg (median), with no clinically
audible leak throughout the surgery. The PAP did
not increase beyond the oropharyngeal seal pressure
throughout surgery. This is in accordance with the
findings of previous studies.[1,3,6,7]
In three patients, gastric distention was successfully
decompressed by suctioning the NGT. There was no
incidence of regurgitation or aspiration in either group.
Similar results have been reported by others.[1,13,14]
The incidence of sore throat was comparatively
more in the intubation group E (20%) than in group
P (10%). All patients were administered gargles and
steam inhalation. After 24 hours, none of the patients
in the Proseal group had sore throat; however, two
patients in group E had persistent sore throat till 48
hours. Higgins et al. and Shroff et al. also found the
greatest incidence of sore throat in patients undergoing
intubation than in those in whom a PLMA was
used.[4,14] The virtual absence of sore throat in PLMA
group could be explained by the fact that it is a
supraglottic device and mucosal pressures achieved
are usually below pharyngeal perfusion pressures.[15]
Although endotracheal intubation is the gold
standard in laparoscopic surgeries done under general
anaesthesia, the PLMA proved to be an equally
effective airway tool in laparoscopic surgeries in terms
of adequate oxygenation and ventilation with minimal
intraoperative and postoperative complications. The
haemodynamic stress response was also minimal with
PLMA when compared to endotracheal intubation.
It provided equally effective pulmonary ventilation
despite high airway pressures without significant
gastric distention, aspiration, and regurgitation.
CONCLUSION
Hence, we conclude that the PLMA proved to be
a suitable and safe alternative to ETT for airway
management in elective fasted, adult patients
undergoing laparoscopic surgeries.
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