ORIGINAL ARTICLE

Comparison of Laryngeal Mask Airway Supreme and

Laryngeal Mask Airway Proseal with respect to
oropharyngeal leak pressure during laparoscopic
cholecystectomy: a randomised controlled trial
Jose M. Belena, Monica Nunez, Diego Anta, Maria Carnero, Jose L. Gracia, Jose L. Ayala,
Raquel Alvarez and Javier Yuste
Context A comparison of the efficacy and safety of the Laryngeal
Mask Airway (LMA) Supreme (LMAS) versus the LMA Proseal
(LMAP) in elective laparoscopic cholecystectomy.
Objectives To compare the LMAS with LMAP in terms of
ventilatory efficacy, airway leak pressure (airway protection),
ease-of-use and complications.
Design Prospective, single-blind, randomised, controlled study.
Setting The Hospital del Sureste and Hospital Ramon y Cajal,
Madrid, between May 2009 and March 2011. The Hospital del
Sureste is a secondary hospital and Hospital Ramon y Cajal is a
tertiary hospital.
Patients Patients undergoing elective laparoscopic
cholecystectomy were studied following informed consent.
Inclusion criteria were American Society of Anesthesiologists
physical status I to III and age 18 or more. Exclusion criteria were
BMI more than 40 kg m
2, symptomatic hiatus hernia or severe
gastro-oesophageal reflux.
Interventions Anaesthesiologists experienced in the use of
LMAP and LMAS participated in the trial. One hundred twentytwo patients were randomly allocated to LMAS or LMAP.
Main outcome measures Our primary outcome measure was
the oropharyngeal leak pressure (OLP). Secondary outcomes
were the time and number of attempts for insertion, ease of
insertion of the drain tube, adequacy of ventilation and the

Introduction
The widespread use of supraglottic airway devices has
revolutionised clinical anaesthesia and offers a genuine
alternative to tracheal intubation in certain situations.
One example is laparoscopic surgery, an approach that
may increase the risk of regurgitation due to peritoneal
insufflation. The safety of the Laryngeal Mask Airway
Proseal (LMAP) in this setting, with its high seal pressure
and gastric drain tube, has been established.14
The LMA Supreme (LMAS) has recently been added to
the LMA family as a new single-use device that shares
From the Department of Anaesthesiology and Critical Care, Hospital Universitario
del Sureste, Arganda del Rey (JMB, DA, MC, JLG, RA, JY), Department of
Anaesthesiology and Critical Care, Hospital Universitario Ramon y Cajal (MN),
Department of Anaesthesiology and Critical Care, Hospital Infanta Elena,
Valdemoro, Madrid, Spain (JLA)
Correspondence to Jose M. Belena, Department of Anaesthesiology and Critical
Care, Hospital del Sureste, C/ Ronda del Sur, 10. 28500 Arganda del Rey,
Madrid, Spain
Tel: +34 91 839 4184; fax: +34 91 839 4378;
e-mail: josemariabelena@yahoo.es
0265-0215 2013 Copyright European Society of Anaesthesiology

incidence of complication. Patients were interviewed

postoperatively to evaluate the presence of sore throat,
dysphagia or dysphonia.
Results Two patients were excluded when surgery changed
from laparoscopic to open. A total of 120 patients were finally
included in the analysis. The mean OLP in the LMAP group was
significantly higher than that in the LMAS group (30.7  6.2
versus 26.8  4.1 cmH2O; P < 0.01). This was consistent with a
higher maximum tidal volume achieved with the LMAP compared
to the LMAS (511  68 versus 475  55 ml; P 0.04). The
success rate of the first attempt insertion was higher for the
LMAS group than the LMAP group (96.7 and 71.2%,
respectively; P < 0.01). The time taken for insertion, ease of
insertion of the drain tube, complications and postoperative
pharyngolaryngeal adverse events were similar in both
groups.
Conclusion The LMAP has a higher OLP and achieves a higher
maximum tidal volume compared to the LMAS, in patients
undergoing elective laparoscopic cholecystectomy. The
success of the first attempt insertion was higher for the LMAS.
Eur J Anaesthesiol 2013; 30:119123
Published online 11 January 2013
Keywords: laparoscopic cholecystectomy, Laryngeal Mask Airway Proseal,
Laryngeal Mask Airway Supreme

attributes with LMA Fastrach and LMAP. Its curved

shape makes it easy to insert and the effective oropharyngeal seal pressure together with drain tube allows the
LMAS to be used in laparoscopic surgery. Studies to date
have not achieved a consensus regarding leak pressures of
the LMAS and LMAP, and there is little information on
laparoscopic cholecystectomy because most studies have
investigated gynaecological laparoscopy.
The purpose of this prospective randomised study was to
compare the LMAS and LMAP in fasted adults undergoing elective laparoscopic cholecystectomy. Our
primary outcome was the oropharyngeal leak pressure
(OLP). Our secondary outcomes were as follows: number
of attempts, ease of insertion of the device and the gastric
tube, time to reach correct ventilation and adverse events
including postoperative sore throat.

Materials and methods

Ethical approval for this study was provided by the
Ethical and Investigation Committee of the Hospital
DOI:10.1097/EJA.0b013e32835aba6a

Copyright European Society of Anaesthesiology. Unauthorized reproduction of this article is prohibited.

120 Belena et al.

Universitario del Sureste, Arganda del Rey, Madrid,

Spain (Chairperson Dr F.J. Yuste) on 15 May 2009. After
written informed consent, fasted patients of American
Society of Anesthesiologists Physical Status (ASA) classes
I to III undergoing elective laparoscopic cholecystectomy
were recruited. Patients were excluded if they were less
than 18 years, having ASA class IV or V, with BMI more
than 40 kg m
2, symptomatic hiatus hernia or severe
gastro-oesophageal reflux.
Patients were randomly allocated using computergenerated numbers. Allocation was concealed using
opaque sealed envelopes that were opened just prior
to induction of general anaesthesia.
The size of LMAS and LMAP was chosen according to
the manufacturers recommendations based on weight
(size 3 for patients weighing 30 to 50 kg; size 4, 50 to
70 kg and size 5, >70 kg).5 All the devices were completely deflated to standardise the comparison between
the devices. The posterior surface of the LMA was
lubricated with a water-soluble lubricant (Sulky; Laboratorios Bohm S.A., Madrid, Spain).
Routine monitoring of electrocardiograph, non-invasive
blood pressure and pulse oximetry was begun before
induction of anaesthesia. All patients were premedicated with midazolam 0.04 mg kg
1 and remifentanil
0.1 mg kg
1 min
1 intravenously (i.v.). Anaesthesia was
induced in the supine position with the head on a
standard pillow 7 cm in height. After preoxygenation
for 3 min, remifentanil 0.3 mg kg
1 min
1 and propofol
2 to 3 mg kg
1 were given. No muscle relaxant was used
at this time. We continued ventilating with 100% oxygen
using a facemask for at least 1 min until optimum conditions for LMA insertion were achieved (relaxation of
the jaw, loss of eyelash reflex, immobility and apnoea).
The LMAS was inserted with the head in the semisniffing position using a single-handed technique such as
that suggested by the manufacturer.5 The LMAP was
inserted using the manual technique in the sniffing
position. Cuff pressure was monitored using a handheld
manometer (Ambu, Ballerup, Denmark) to achieve
60 cmH2O in both devices. A closed circle system was
connected (inspired tidal volume 8 ml kg
1, respiratory
rate of 12 breaths min
1, I: E ratio of 1 : 2 and fresh gas
flow 3 l min
1). Effective ventilation was defined as a
square-wave tracing on the capnograph with end-tidal
CO2 (EtCO2) values from 30 to 45 mmHg and normal
thoracoabdominal movements. The LMA was repositioned if necessary to achieve this. The number of
insertion attempts was recorded. Three attempts were
allowed before insertion was considered a failure. The
anaesthesiologist ventilated the patient using the facemask between attempts. The time taken for insertion was
defined as the time from removing the facemask to the
first valid capnography trace. Drain tube air leaks were
detected by placing lubricant into the drain tube and

detecting upcoming bubbles during ventilation. When

mechanical ventilation was ineffective (maximum
expired tidal volume <6 ml kg
1 or EtCO2 >45 mmHg),
), the cuff was deflated to zero pressure and the LMA
repositioned by gentle up and down or lateral movements. If ventilation continued to be suboptimal, one
further insertion attempt was allowed. When ventilation
was impossible or ineffective after the third attempt, we
defined it as ventilation failure. In case of insertion or
ventilation failure, endotracheal intubation was performed.
A well lubricated 120 cm long, #14 Salem sump gastric
tube (Vecmedical Spain S.L., Barcelona, Spain) was
inserted via the drain tube and ease of insertion was
recorded (easy to insert, difficult to insert and impossible
to insert). Finally, we secured the LMA to the face with
adhesive tape. Four anaesthesiologists experienced in the
use of LMA Classic (>1000 uses), LMAP (>100 uses)
and LMAS (>50 uses) participated in the trial. A second
anaesthesiologist was available to collect data as an
independent observer.
Anaesthesia was maintained with sevoflurane (2% endtidal) in 50% oxygen in air, and remifentanil 0.15 to
0.5 mg kg
1 min
1. Once ventilation and anaesthesia
had stabilised, the expiratory valve of the circle system
was closed at a fixed gas flow of 3 l min
1, and the OLP
was recorded. This was the airway pressure generated (for
safety, the maximum allowed was 40 cmH2O) when an
audible noise was heard over the mouth.6 After that,
rocuronium 0.6 mg kg
1 was given to maintain neuromuscular blockade at one twitch of a train-of-four
(TOF-Watch; Organon Ltd, Dublin, Ireland).
We recorded the peak airway pressure from the anaesthesia system Fabius GS (Drager Medical AG & Co.KG,
Lubeck, Germany). Peak airway pressures were recorded
before and after the carboperitoneum in the supine
position and in the reverse Trendelenburg position.
Peritoneal insufflation pressure was set at 13 mmHg7
and head-up tilt was limited to 308.
Cardiorespiratory data were collected every 3 min during
the anaesthetic procedure by the monitoring computer
program (Picis Care Suit Anesthesia Manager; Picis Ltd,
Wakefield, MA, USA). Ventilatory variables were monitored continuously and adjusted accordingly to maintain
SpO2 more than 95% and EtCO2 less than 45 mmHg.
Peritoneal insufflation time and total anaesthetic time
were also recorded.
The LMA was removed when the patient was awake and
responded to verbal orders. The presence of any of the
following complications was recorded by the observer:
cough, laryngeal stridor, laryngospasm, bronchospasm,
regurgitation, aspiration, hypoxia (SpO2 <90%) and presence of blood following removal of the LMA. After
monitoring in the postoperative acute care unit (PACU),

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LMA Supreme versus LMA Proseal for laparoscopic cholecystectomy

a second assessor blinded to the allocation group,

assessed the patients for postoperative pain using a verbal
questionnaire which evaluated the presence of sore
throat, pain on swallowing and pain on speaking, before
leaving the operating room (0 h) and postoperatively in
the PACU (2 h) using a 0 to 10 visual analogue scale (VAS)
where 0 absence of sore throat, dysphagia or dysphonia
and 10 unbearable sore throat, total dysphagia or dysphonia. All the patients received a standard postoperative
analgesic regime of paracetamol (1 g) and dexketoprofen
(50 mg) i.v.
Statistical analysis

Our sample size was based on the results of a previous

study, in which the LMAP was found to have an OLP of
25 cmH2O with a standard deviation of 6 cmH2O.8 To
detect a clinically significant difference of 10% between
the two groups, with a equal to 0.05 and power of 85%
(1
b 0.85) using a two-sided test, 57 patients per group
were needed. This was increased to 60 to allow for the
potential for dropout.
We analysed the data with SPSS version 17 (SPSS Inc.,
Chicago, Illinois, USA). Continuous data were analysed
using Students t-test. Non-parametric data were analysed using the two independent samples MannWhitney test. Nominal data were analysed with the x2 test.
Logistic regression was used to determine the factors
associated with OLPs. A P value less than 0.05 was
considered significant.

Results
Two patients were excluded when the surgical approach
changed from laparoscopy to laparotomy, and these were
replaced, leaving 120 (60 per group) for analysis. Personal
data were similar for both groups (Table 1).
The mean OLP with the LMAS group was significantly
lower than that in the LMAP group (26.8  4.1 versus
30.7  6.2 cmH2O; P < 0.01). This finding was consistent
with a lower maximum tidal volume achieved with the
LMAS compared to the LMAP (475  55 versus
511  68 ml; P 0.04) and matched the OLP values.
Success rate on first attempt insertion was higher for the
LMAS group than the LMAP group (96.7 and 71.2%,
Table 1

121

respectively; P < 0.01). The median time taken for insertion was similar (11.78 s in the LMAS versus 11.20 s in the
LMAP; P 0.2). There were no failed insertions in either
group. More than 95% of insertions were reported to be
easy for both devices. Only two cases were graded as
difficult in the LMAP group, and none in the LMAS
group (Table 2).
There was no statistical difference in ease of insertion of
the drain tube (P 0.06). Intraoperative complications
were similar in both groups. No episodes of laryngeal
stridor/laryngospasm/bronchospasm, hypoxia, regurgitation or aspiration were seen. Cough at the time of withdrawal occurred in five patients (8.3%) in LMAS group
and six (10%) in LMAP group. Blood was noted after
removal of the LMAP in two cases. There were no
differences between LMAS and LMAP with respect to
incidence of postoperative sore throat (P 0.13 at 0 h and
P 0.06 at 2 h). No patients reported dysphagia or
dysphonia.

Discussion
The findings of our study show that OLP in the LMAS
group was lower than that in the LMAP group. Based on
the results of secondary outcomes, the LMAS was easier
to insert than LMAP. We did not find any significant
differences with respect to insertion of the drain tube,
incidence of postoperative sore throat or other adverse
events.
There are many reports of the use of the LMA for
laparoscopic surgery, mostly testing the LMA Classic
against the LMAP13,9, and more recently, the
LMAS4,10,11 and the I-gel7,12 for laparoscopy. This is
the first clinical study comparing safety and efficacy of
LMAS and LMAP in patients undergoing laparoscopic
cholecystectomy.
The majority of previous studies only included ASA I and
II patients. We were not restrictive and as a result, 10.8%
of the patients were ASA III. Our exclusion threshold for
BMI excluded those with a BMI greater than 40 kg m
2
but permitted inclusion of eight with BMI between
30 and 40 kg m
2. In this subgroup, although small, both
LMAS and LMAP proved to be safe during laparoscopy,

Patient data and timings

Sex (F/M)
Age (year)
Weight (kg)
Height (cm)
BMI (kg mS2)
ASA I/II/III
Surgical time (min)
Peritoneal insufflation time (min)
Duration of anaesthesia (min)
LMA size (3/4/5)

Supreme (n U 60)

Proseal (n U 60)

35/25
53  14
74  12
162  9
25  4
17/35/8
76  30
57  28
100  37
7/36/17

40/20
49  17
70  13
161  8
27  5
21/34/5
70  29
55  31
98  38
8/40/12

0.59
0.73
0.24

ASA, American Society of Anesthesiologists; LMA, laryngeal mask airway. Values are presented as mean  SD or numbers.

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122 Belena et al.

Table 2

Efficacy and postoperative sore throat

Oropharyngeal leak pressure (cmH2O)

First attempt success rate (%)
Time taken for insertion (s)
Ease for gastric tube insertion (easy/difficult/impossible)
Maximum tidal volume (ml)
Peak airway pressure before pneumoperitoneum (cmH2O)
Peak airway pressure after pneumoperitoneum (cmH2O)
Peak airway pressure after pneumoperitoneum and reverse Trendelenburg (cmH2O)
Postoperative sore throat at 0 h; mild (<3 in VAS scale) (%)
Postoperative sore throat at 2 h; mild (<3 in VAS scale) (%)

Supreme (n U 60)

Proseal (n U 60)

27  4
97
11.8  2
55/5/0
475  55
18  4
24  4
23  4
12%
17%

31  6
71
11.2  4
51/9/0
511  68
19  3
26  5
25  5
14%
21%

0.002
0.001
0.2
0.06
0.04
0.7
0.34
0.24
0.13
0.06

VAS, visual analogue scale. Values are presented as mean  SD, numbers or percentage.

with no leaks measured and achieving adequate ventilation.

OLP test is commonly performed to quantify the seal
with the airway when a supraglottic device is used. OLP
values have been widely used as a reference for the
assessment of safety of different masks. The leak pressure can indicate the success of positive pressure ventilation and the degree of airway protection6 and is
regarded as the most important value when testing the
suitability of a LMA for laparoscopic surgery.3,13
Several clinical studies have compared the OLP in
LMAS versus LMAP with different results. Verghese
and Ramaswamy14 presented a prospective randomised
crossover study of 36 patients comparing LMAS and
LMAP. This study showed no differences in OLP
between devices, although it only included female
patients with a size 4 LMA. Hosten et al.15 in another
prospective randomised trial found similar OLP values
between LMAS and LMAP, although in this case, only
12 of the 60 patients included underwent laparoscopic
procedures, and muscle relaxants were used in 22%,
which may have affected the measured OLP.
Two other investigators have found differences in mean
OLP values between LMAS and LMAP,8,16 finding that
OLP was 4 to 8 cmH2O lower in the LMAS compared to
the LMAP group, although in both cases, the procedures
were non-laparoscopic. Our findings are consistent with
theirs and with those of Lee et al.4 The results of this
prospective, controlled, randomised study of 70 female
patients (ASA I to II) undergoing elective gynaecological
procedures, are comparable to ours, although there are
some differences worthy of note. Their study sample size
was smaller, all patients were women and mivacurium
was administered before measurement of OLP. We
decided not to use muscle relaxants before insertion of
the LMA, because the device can be inserted easily
without their administration if an adequate depth of
anaesthesia is reached,17 and there is some evidence
suggesting that the use of neuromuscular blocking agents
can alter the LMA leak pressures and may result in a
lower measured OLP.18 We did, however, provide neuromuscular blockade during laparoscopy.

The higher OLP for the LMAP is mainly related to the

dorsal cuff and the silicone rubber double cuff design
compared to the polyvinyl chloride single cuff of the
LMAS. Some authors19 have suggested that the lower
OLP observed in LMAS may be due to the movement of
the semi-rigid curved airway tube, something which does
not seem to happen with the elastic tube of the LMAP.
The I-gel supraglottic airway device has recently been
compared with the LMAP and the LMAS separately,
looking for differences in OLP in laparoscopic surgery. In
one study, a higher OLP was reached with the LMAP,12
but no differences were found between the I-gel and the
LMAS regarding OLP values.7
Another important aspect that should be considered is the
ease of insertion. In our study, we found a superior
success rate on the first attempt in the LMAS group
compared to the LMAP. Similar results were found by
Seet et al.,8 but we did not find any differences in the
median time taken for insertion. The curved semi-rigid
airway tube of the LMAS, similar to the intubating LMA
Fastrach, may facilitate the insertion of this device and
may explain why none of the insertions in the LMAS
group were graded as difficult. Some authors have proposed a guide insertion technique for the LMAP to
improve digital insertion,20 but this would require training. Most of the studies comparing LMAS and LMAP
have failed to demonstrate any differences in the success
rate at first insertion,4,15,16 but neuromuscular blocking
agents were used, and the more favourable conditions
created can influence the results. Moreover, the sample
size was too small to detect any difference, as the maximum number was 93 in the study by Eschertzhuber
et al.16 We agree with Pearson and Young21 that the
LMAS is a real option for airway rescue situations, in
which there is no immediate access to suitable help and
emergency intubation is an unacceptable risk.
Despite the fact that both devices have been manufactured using different materials, we found no differences
in gastric tube placement.
The complication rate in our study was low in both
groups, which is comparable to other reports that evaluated these airway devices.4,22 Nor were there significant

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LMA Supreme versus LMA Proseal for laparoscopic cholecystectomy

differences in the incidence of sore throat.8,2224 Mucosal

injury, recognised by blood on the device after removal,
was present in only 1.7% of patients in the LMAP group
(no cases in the LMAS group), which is less than that in
other reports4,8,23,25 and the incidence of cough was low
and comparable for both masks. Consistent with other
studies, dysphagia or dysphonia and other adverse events,
such as laryngeal stridor, laryngospasm, bronchospasm,
hypoxia, regurgitation or aspiration and neurovascular
events were not reported.8,13,17. On the basis of these
findings, we suggest that LMAS and LMAP are effective
ventilatory devices for laparoscopic cholecystectomy with
a low morbidity.
Our study has some limitations. First, and for obvious
reasons, the anaesthesiologist involved in timing the
events in the operating room was not blind to the type
of device. To mitigate this, postoperative outcome assessors and patients were blinded to the group assignment.
Second, we only investigated one type of surgery,
although laparoscopic procedures are valuable for studying the safety and efficacy of these devices.

Conclusion
In conclusion, we found that the LMAP had a higher
OLP and achieved a higher maximum tidal volume
compared to the LMAS, in patients undergoing general
anaesthesia for elective laparoscopic cholecystectomy.
The success rate of the first insertion was higher for
the LMAS group and this could have important implications when using the LMAS as an airway rescue device.
The ease of insertion of the drain tube, adequacy of
ventilation and complication rates are comparable for the
two airway devices.

5
6

10

11

12

13

14

15

16

17

18

Acknowledgements
Assistance with the study: the authors wish to thank Francisco
J.Yuste, MD, PhD for his cooperation and interest in this study.

19
20

Financial support and sponsorship: none declared.

21

Conflicts of interest: none declared.

22

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23

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