ORIGINAL ARTICLE

Gastric Distension With SLIPA Versus LMA ProSeal During

Laparoscopic Cholecystectomy: A Randomized Trial
Su Man Cha, MD,* Sihyun Park, RN, MSN,w Hyun Kang, MD, PhD,zy
Chong Wha Baek, MD, PhD,z Yong Hun Jung, MD, PhD,z
Young Joo Cha, MD, PhD,y8 and Junyong In, MD, PhDz

Background: We compared the quantitative clinical performances

of the streamlined liner of the pharynx airway (SLIPA) and the
ProSeal laryngeal mask airway (LMA ProSeal) regarding intensity
of gastric distension in patients undergoing laparoscopic
cholecystectomy.
Methods: A total of 124 anesthetized, paralyzed patients (ASA 1 to
2; aged, 18 to 80 y) were randomly allocated for airway management with the SLIPA or LMA ProSeal. After induction of general
anesthesia using total intravenous anesthesia and rocuronium, the
intensity of gastric distension was accessed twice by 2 raters,
respectively. We also compared the fiberoptic bronchoscopic view
of the glottis, the severity of blood stain, and postoperative sore
throat.
Results: There were no statistically significant differences between
groups for each gastric size. The change of gastric size within the
SLIPA group was not statistically significant for both raters.
Change within the LMA ProSeal group was significant in rater 2
(P = 0.045) and marginally significant for rater 1 (P = 0.056).
Anatomic fit, complications during emergence, and the severity of
blood stain and postoperative sore throat were similar in both
groups.
Conclusions: SLIPA is as efficacious as LMA ProSeal for use in
patients without severe complications who are undergoing laparoscopic cholecystectomy.
Key Words: gastric distension, laparoscopic cholecystectomy, laryngeal mask airway, SLIPA

(Surg Laparosc Endosc Percutan Tech 2014;24:216220)

he streamlined liner of the pharynx airway (SLIPA;

SLIPA Medical Ltd, London, UK) is becoming recognized as a safe and effective supraglottic airway for airway
management during surgery.110

Received for publication January 16, 2013; accepted March 4, 2013.

From the *Department of Anesthesiology and Pain Medicine, College
of Medicine, Ajou University, Suwon; zDepartment of Anesthesiology and Pain Medicine; 8Department of Laboratory Medicine;
yMedical Device Clinical Trials Center, College of Medicine,
Chung-Ang University, Seoul; zDepartment of Anesthesiology and
Pain Medicine, Ilsan Hospital, Dongguk University Medical
Center, Goyang, Republic of Korea; and wSchool of Nursing,
University of Washington, Seattle, WA.
Supported by a grant of the Korea Healthcare Technology R&D
Project, Ministry of Health and Welfare, Republic of Korea
(A100054).
The authors declare no conflicts of interest.
Reprints: Hyun Kang, MD, PhD, Department of Anesthesiology and
Pain Medicine, College of Medicine, Chung-Ang University, 224-1
Heukseok-dong, Dongjak-gu, Seoul 156-755, Korea (e-mail:
roman00@naver.com).
Copyright r 2014 by Lippincott Williams & Wilkins

216 | www.surgical-laparoscopy.com

In laparoscopic cholecystectomy, because stomach

and gallbladder are anatomically adjacent, gastric distension can obstruct the operators field of vision and
interfere with surgical manipulation, which makes it
imperative to lower the incidence and intensity of gastric
distension. The effectiveness of supraglottic airway during
laparoscopic cholecystectomy has been studied in terms of
gastric insufflations and distension.1113 Such studies
reported that the classical laryngeal mask airway (LMA
Classic) and the ProSeal laryngeal mask airway (LMA
ProSeal; Laryngeal Mask Company, Henley-on-Thames,
UK) were comparable to an endotracheal tube regarding
the change in gastric distension during laparoscopic
cholecystectomy.
However, to the best of our knowledge, there is no
study concerning the use of SLIPA in laparoscopic cholecystectomy. SLIPA was compared with LMA ProSeal on
gastric distension only in lower abdominal laparoscopic
surgery6,8 and ill-defined surgeries (requiring supine position during operation).5 In addition, although SLIPA
offered the advantage of less perilaryngeal gas leakage and
a similar incidence of gastric insufflations compared with
LMA ProSeal in previous studies,5,6,8 the results did not
include quantitative measurement regarding gastric distension, which make it more difficult to determine differences in gastric distension than when using quantitative
measurements in laparoscopic cholecystectomy. Accordingly, we developed a new quantitative tool to measure
severity of gastric distension.
The aim of this study was to compare the quantitative
clinical performance of the SLIPA with the LMA ProSeal
with regard to intensity of gastric distension when used in
patients undergoing laparoscopic cholecystectomy. We also
compared fiberoptic view of the glottis, complications
during emergence, and the severity of blood stain and
postoperative sore throat.

METHODS
The study protocol was approved by the Institutional
Review Board of Chung-Ang University School of
Medicine [c2011091 (541)] and the study is registered with
the Australian New Zealand Clinical Trials Registry
(ACTRN12611001189910) (https://www.anzctr.org.au/Trial/
Registration/TrialReview.aspx?id=347718). This study was
carried out according to the principles of the Declaration of
Helsinki (2000) and written informed consent was obtained
from all patients.
We recruited 124 healthy (ASA 1 to 2) individuals,
aged 18 to 80 years, who required elective laparoscopic
cholecystectomy and were eligible for enrollment in the
study. We excluded patients with a history of diabetes

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mellitus, gastroesophageal reflux, other neurological or

musculoskeletal diseases, obesity (body mass index >30 kg/
m2), or with features or history of a difficult airway. The
decision to enroll was made by one author who did not
otherwise participate in this study. The patients were randomly divided into a SLIPA (n = 62) and a LMA ProSeal
(n = 62) group. Randomization into 1 of the 2 groups was
based on random table generated using R-program. Block
randomization with a block size of 4 or 6 and equal allocation was used to prevent imbalances in treatment
assignments. The randomization sequence was generated by
a statistician who is not involved with the study. Patient
group allocation was revealed to the investigator immediately before induction of anesthesia by means of numbered,
sealed envelopes.
One anesthesiologist with >4 years of experience with
airway management using LMA ProSeal and with >1 year
of experience with SLIPA was selected to administer
supraglottic airway for this study. A second anesthesiologist recorded data as an independent observer.
No premedication was given. After placement of
standard monitoring systems (electrocardiography, noninvasive arterial blood pressure sensing, and pulse oximetry) and BIS monitoring system and preoxygenation for
3 minutes, lidocaine (0.5 mg/kg) was administrated intravenously to prevent propofol injection pain. Propofol was
started at a plasma concentration of 3 to 4 mg/mL with
remifentanil (4 to 6 ng/mL). Rocuronium (0.6 mg/kg) was
given when the patient lost consciousness. Ventilation was
controlled through a facemask with 100% O2. To avoid
gastric insufflation, the lungs were gently ventilated with
maintaining adjustable pressure-limiting valve at 15 cm
H2O until sufficient jaw relaxation.
When the jaw was sufficiently relaxed, the SLIPA or
LMA ProSeal was inserted. In the SLIPA group, size was
chosen by the width across the thyroid cartilage.3 In the
LMA ProSeal group, size 3 was used for patients weighing
<50 kg, size 4 for those weighing 50 to 70 kg, and size 5 for
those >70 kg according to the manufacturers recommendations. Normal saline was used for lubrication in both
supraglottic airways. After insertion, the cuff in the LMA
ProSeal group was maintained <60 cm H2O with a hand
pressure gauge (Cuff pressure gauge; VBM Medizinetechnik GmbH, Sulz, Germany).
If the initial attempt at insertion into the pharynx was
unsuccessful, a second attempt at insertion was made using
a supraglottic airway of smaller size, respectively. If the
second attempt at insertion was unsuccessful, it was
recorded as an insertion failure and the supraglottic airway
was shifted with endotracheal tube.
After a successful insertion, ventilator parameters were
set at a tidal volume 10 mL/kg of the patients ideal body
weight,14 respiratory rate of 10 breaths/min, and an
inspiratory-to-expiratory ratio of 1:2 using a volume-controlled ventilator (Datex-Ohmeda Aestiva/5 ventilator; GE
Health Care, Madison, WI). We considered that effective
ventilation was achieved when a square wave capnograph
trace was obtained and audile leakage did not develop.
Although airway insertion was successful, if appropriate
capnograph could not be obtained until the fifth mechanical ventilation or an audible leakage developed, we
regard it as ineffective ventilation and tried manipulation to
adjust the supraglottic airway. In the SLIPA group, we
repositioned the device. In the LMA ProSeal group, up to
10 mL of air was added in the LMA ProSeal cuff at
r

2014 Lippincott Williams & Wilkins

SLIPA and LMA-P in Laparoscopic Cholecystectomy

maximal 60 cm H2O with a hand pressure gauge, but if the

problem persisted in the LMA ProSeal, we repositioned
after deflating a cuff. If effective ventilation still could not
be achieved through repositioning on 2 groups, the device
was completely removed in preparation for supraglottic
airway of larger size. If effective ventilation could not be
achieved with a larger size supraglottic airway, equal
manipulation that was tried to adjust the supraglottic
airway before the decision of device change was performed
for correction. However, if the correction was still not
effective, it was recorded as an effective ventilation failure
and the supraglottic airway was changed to an endotracheal
tube.
After SLIPA or LMA ProSeal insertion, respiratory
rate was adjusted according to the range of end tidal CO2
(30 to 35 mm Hg). The inspired oxygen fraction was 0.5
with air while maintaining a fixed fresh gas flow of 3 L/min.
If 4 twitches were observed before removal of gallbladder
while monitoring train-of-four in the adductor pollicis
muscle, additional rocuronium (0.1 mg/kg) was administered. If >10% difference existed between the inspiration
and expiration tidal volume on spirometry (S/5TM Compact
anesthesia monitor; Datex-Ohmeda, Tewksbury, MA) at
any time during the operation except during position
change and the start or finish of pneumoperitoneum, we
attempted same manipulation to adjust the supraglottic
airway. However, if equal manipulation was not effective, it
was recorded as maintenance failure and the supraglottic
airway was changed to an endotracheal tube.
Anatomic fit was checked using a flexible fiberoptic
bronchoscope (Olympus BF-3C40; Olympus Optical,
Tokyo, Japan) and this was graded by a second anesthesiologist. The fiberoptic view was assessed by the grading
system of Joshi et al15: grade 1, vocal cords not seen; grade
2, vocal cords plus the anterior epiglottis seen; grade 3,
cords plus the posterior epiglottis seen; and grade 4, only
vocal cords seen.
Peritoneal insufflations pressure was maintained at
15 mm Hg using CO2. After the patient was placed in
reverse Trendelenburg position (30 degrees) and tilted
downward to the patients left (10 degrees), the surgeon,
who did not know which supraglottic airway was used,
assigned a gastric distension score by using a direct visualizing laparoscope (pregastric distension score). Before the
CO2 was evacuated and patient position changed at the end
of surgery, the surgeon again assigned a gastric distension
score (postgastric distension score). The scores of all cases
were assessed by the same surgeon (rater 1). The gastric
distension score scale ranged from 0 to 10 (Fig. 1). An
independent examiner (rater 2) evaluated gastric distension
scores through recorded screen on a separate workstation
without any prior knowledge of the patients history or
surgery. In addition, we defined the gastric distension score
>5 as manipulation-needed case, of which the incidences
were evaluated.
At the end of the operation, neostigmine and glycopyrrolate were given to reverse neuromuscular block. The
supraglottic airway was removed when the patient resumed
spontaneous breathing (when the VT reached 8 mL/kg and
the patient was able to obey commands) and it was
inspected for the presence of visible regurgitant or any
blood. Any breathing problems were recorded in emergence
(including cough, vomiting, laryngospasm, or need for
positive ventilation or airway intervention). One blinded
investigator collected the postoperative sore throat score at
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FIGURE 1. The gastric distension score scale.

30 minutes and 1 day after emergence (none, mild, moderate, and severe).
The primary outcome measurement of the study was
the comparison of the degree of gastric distension between
2 groups at the end of surgery (postgastric distension score).
Additional analyses were performed with regard to pregastric distension score, anatomic fit, any problems during
emergence, and the severity of blood stain and postoperative sore throat.

analyzed using the Mann-Whitney U test. The Wilcoxon

signed-rank test was used to compare pregastric and postgastric distension scores, and the Spearman r was computed to determine the reliability of interrater agreement.
Descriptive variables were subjected to w2 analysis or
the Fischer exact test, as appropriate, and P-values <0.05
were considered statistically significant. Statistical analysis
was performed using SPSS ver. 18.0 (SPSS Inc., Chicago,
IL).

Sample Size Calculation and Statistics

To estimate the group size, a pilot study was conducted for measuring the degree of gastric distension at the
end of surgery (postgastric distension score) in 20 patients
(10 in LMA-Proseal and 10 in SLIPA). Postgastric distension score of pilot study was normally distributed, and
its mean and SD of the postgastric distension score for
LMA Proseal and SLIPA were 3.7 (1.9) and 2.6 (1.1),
respectively. We wanted the capability to show a difference
of 1 in the gastric distention score between the groups. With
a = 0.05, 2-tailed and a power of 90%, we required 54
patients per group.
Considering the patient insertion failure rate, effective
ventilation failure, and maintenance failure rate of 9%, 2%,
and 2%, respectively, we required 124 patients for the
study.
For intergroup comparisons, the distributions of the
data were first evaluated for normality using the ShapiroWilk test. The normally distributed data are presented as
the mean (SD), and groups were compared using unpaired
the Student t tests. The non-normally distributed data are
expressed as medians (interquartile range) and they were

RESULTS
A total of 124 patients were recruited for this study
between July 2011 and January 2012.
Regarding insertion failure, 1 patient was excluded in
the SLIPA group and no patients were excluded in the
LMA ProSeal group. Regarding effective ventilation failure, 1 patient was excluded in the SLIPA group and 3
patients were excluded in the LMA ProSeal group.
Regarding maintenance failure, 3 patients in the SLIPA
group and 3 patients in the LMA ProSeal group were
excluded from analysis. One patient in the SLIPA group
was excluded from analysis due to conversion to an open
method by severe adhesion.
Data were analyzed from 112 patients. Demographic
data, anesthesia, and pneumoperitoneum time were similar
for both groups (Table 1).
There was no statistically significant difference
between groups for pregastric and postgastric distension
scores. The change from pregastric distension score to
postgastric distension score in the SLIPA group was not
statistically significant for both raters. The change in the

TABLE 1. Demographic Data

Age (y)
Sex: M/F (n)
Height (cm)
Weight (kg)
ASA grade 1, 2 (n)
Size
LMA ProSeal: 3/4/5 (n)
SLIPA: 49/51/53 (n)
Anatomic fit
I/II/III/IV (n)
Duration of Ane (min)
Duration of Pn (min)

LMA ProSeal
(n = 56)

SLIPA
(n = 56)

45.50 (34.00-54.75)
29/27
160.43 9.89
61.20 13.93
39/17

41.00 (33.00-51.75)
27/29
162.89 7.12
64.43 10.33
42/14

0.547
0.705
0.134
0.166
0.526

10/30/16

24/5/21

0/2/10/44
74.00 (61.25-88.75)
46.00 (36.00-63.50)

0/4/11/41
75.00 (65.25-95.00)
50.00 (41.00-66.75)

0.664
0.341
0.180

Values are expressed as mean SD, median (interquartile range), or absolute number.
No significant differences between groups.
Ane indicates anesthesia; ASA, American Society of Anesthesiologist Physical Status; LMA ProSeal, ProSeal laryngeal mask
airway; Pn; pneumoperitoneum; SLIPA, streamlined liner of the pharynx airway.

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SLIPA and LMA-P in Laparoscopic Cholecystectomy

TABLE 2. Gastric Distension Score

G score
R1
Pre-G
Post-G
R2
Pre-G
Post-G

LMA ProSeal (n = 56)

Pre-Post

SLIPA (n = 56)

0.056
2.00 (2.00-3.00)
2.00 (2.00-4.00)

Pre-Post

2.00 (2.00-3.00)
2.00 (1.00-3.00)
0.045*

2.00 (1.00-3.00)
3.00 (2.00-4.00)

Between Groups

0.543
0.889
0.050
0.856
2.00 (2.00-3.00)
2.00 (2.00-3.00)

0.647
0.056

Values are expressed as median (interquartile range).

Mann-Whitney U test is used to compare gastric distension score between groups, and Wilcoxon signed-rank test is used to compare pre-G and post-G
scores.
No significant differences between groups.
*Statistical significance between pregastric and postgastric distension scores.
G indicates gastric distension; LMA ProSeal, ProSeal laryngeal mask airway; post-G, postgastric distension score; pre-G, pregastric distension score; prepost, change from pregastric to postgastric distension score; R1, rater 1; R2, rater 2; SLIPA, streamlined liner of the pharynx airway.

LMA ProSeal group was not statistically significant for

rater 1 but was significant for rater 2 (Table 2). Interrater
agreement was strongly associated with pregastric distension score (r = 0.619, P < 0.001) and fairly associated
with postgastric distension score (r = 0.568, P < 0.001).
The incidences of manipulation-needed case were
similar between groups, and between pregastric and postgastric scores in each groups (Table 3).
Anatomic fit, complications during emergence, and the
severity of blood stain and postoperative sore throat were
similar in both groups (Table 4).

DISCUSSION
This is the first study showing the clinical efficacy of
SLIPA during laparoscopic cholecystectomy and including
quantitative measurement for gastric distension during use
of supraglottic airway.
Because gastric distension can induce gastric perforation during insertion of a laparoscope16 and interfere with
surgical field and manipulation, lower incidence of gastric
insufflation and intensity of gastric distension are important
in laparoscopic cholecystectomy. Therefore, the incidence
of gastric insufflations and intensity of gastric distension
during use of a newly developed airway device should be
checked to reduce operation time and complications in
laparoscopic cholecystectomy.
Maltby et al11 reported that gastric distension when
using a correctly seated LMA Classic of appropriate size
occurred with equal frequency with endotracheal tube during
laparoscopic cholecystectomy. In addition, Maltby et al12 and

Lu et al13 reported that a correctly seated LMA ProSeal

provided effective ventilation without clinically significant
gastric distension during laparoscopic cholecystectomy.
However, there is no study concerning the use of SLIPA
in laparoscopic cholecystectomy. Unlike the LMA ProSeal
that has a cuff with which can correct the sealing by adding
air when perilaryngeal leakage develop, due to fixed shape of
SLIPA, there is a limit to correction of SLIPA in situations
involving inappropriate position and perilaryngeal leakage.
Therefore, the risk of gastric distension and inadequate
ventilation when using a SLIPA during pneumoperitoneum
seems to be greater than when using a LMA ProSeal.
However, our results demonstrate that SLIPA can be
used as effective as LMA ProSeal and without severe
complications in laparoscopic cholecystectomy. Although
SLIPA was studied only for the incidence of gastric insufflations and using a qualitative measure of gastric distension in previous studies, our results supported the previous studies, which showed there was no statistically
significant difference in the incidence of gastric insufflations
when using SLIPA and LMA ProSeal.5,6,8
In our results, there were no statistically significant
differences between groups for pregastric and postgastric
distension size, and the change from pregastric to postgastric distension score in LMA ProSeal for rater 2 was
statistically significant and the change for rater 1 was
marginally significant. Furthermore, the incidences of
manipulation-needed case were similar between groups and
between pregastric and postgastric distension scores.
Accordingly, SLIPA seems to be as effective as LMA
ProSeal, when used in laparoscopic cholecystectomy.

TABLE 3. Manipulation-needed Case

LMA ProSeal (n = 56)

R1 [n (%)]
Pre-G
Post-G
R2 [n (%)]
Pre-G
Post-G

Pre-Post

SLIPA (n = 56)

1.000
3 (5.4)
3 (5.4)

Between Groups

1.000
1 (1.8)
2 (3.6)

1.000
1 (1.8)
1 (1.8)

Pre-Post

0.618
1.000
1.000

0 (0)
1 (1.8)

1.000
1.000

Values are expressed as absolute number (%).

Data were analyzed using the Fisher exact test.
No significant differences between groups, and between pregastric and postgastric distension score.
G indicates gastric distension; LMA ProSeal, ProSeal laryngeal mask airway; post-G, postgastric distension score; pre-G, pregastric distension score; prepost, change from pregastric to postgastric distension score; R1, rater 1; R2, rater 2; SLIPA, streamlined liner of the pharynx airway.

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TABLE 4. Postoperative Complication

Sore throat at PACU

None/mild/moderate/
severe
Sore throat at POD1
None/mild/moderate/
severe
Blood tinged
None/mild/moderate/
severe
Any complication on
emergence

LMA ProSeal
(n = 56)

SLIPA
(n = 56)

28/23/3/2

22/18/10/6

0.069

43/12/0/1

35/17/4/0

0.083

49/3/4

45/8/3

0.274

56/0

55/1*

0.315

Volume 24, Number 3, June 2014

To the best of our knowledge, there is no particular study

concerning the assessment of the position of SLIPA. However, anatomic fit was similar in both groups using this
assessment in our study.
In conclusion, the SLIPA can be used as efficaciously as
LMA ProSeal without severe gastric distension and significant complications during laparoscopic cholecystectomy.

REFERENCES

Values are expressed as absolute number.

No significant differences between groups.
*Laryngospasm.
LMA ProSeal indicates ProSeal layngeal mask airway; PACU, postanesthetic care unit; POD1, post-operative day 1; SLIPA, streamlined liner
of the pharynx airway.

Unlike previous studies, our results were obtained

using quantitative measurements. We used gastric distension scores ranging from 0 to 10 for evaluation of gastric
distension. We established guidelines through surgeons
assessment or manipulation regarding gastric distension for
maintaining quality of our gastric distension score. In an
effort to standardize, the surgeon had undergone a process
of adaptation to gastric distension score. Because our gastric distension score was based on the surgeons assessment
of the difficulty of the operation, this score did not indicate
the exact volume of gastric distension. However, this score
may be able to represent not only an approximate volume
but also provide a practical assessment of gastric distension
during laparoscopic cholecystectomy. For obtaining reliability, our results went through a process of rescoring by
another investigator. Interrater agreement was strongly
associated for the pregastric distension score (r = 0.619,
P < 0.001) and fairly associated for the postgastric distension score (r = 0.568, P < 0.001).
Pregastric distension score exceeding 3 were approximately 30%, which score indicating mild distension and
surgeon careful to distension. Our long ventilation time
before insertion of supraglottic airway and manipulation to
correct the airway may have influenced these results. This
score may not be regarded by some surgeons as a proper
score for starting an operation. However, there were no
cases requiring decompression to proceed with surgery.
Our study has a number of limitations. First, the
duration of pneumoperitoneum was <1 hour in most of the
cases. The results cannot be directly extrapolated to use of
the supraglottic airway in operations of longer duration.
Second, due to our exclusion guidelines, the results cannot
be extrapolated to all patients. Third, the size in the SLIPA
group was chosen by width across the thyroid cartilage.3 If
patient height had been used as a tool for size selection
(http://slipa.com/images/files/slipa%20user%20guide%20v9.
pdf), the results may have been different. Fourth, the method
of assessing the position of the supraglottic airway using a
fiberoptic bronchoscope15 may not be valid for the SLIPA.

220 | www.surgical-laparoscopy.com

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