gastric distension with slipa versus lma proseal during laparoscopic cholecystectomy: a randomized...

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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 manage- ment 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 dierences 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 ecacious as LMA ProSeal for use in patients without severe complications who are undergoing lapa- roscopic cholecystectomy. Key Words: gastric distension, laparoscopic cholecystectomy, lar- yngeal mask airway, SLIPA (Surg Laparosc Endosc Percutan Tech 2014;24:216–220) T he streamlined liner of the pharynx airway (SLIPA; SLIPA Medical Ltd, London, UK) is becoming recog- nized as a safe and eective supraglottic airway for airway management during surgery. 1–10 In laparoscopic cholecystectomy, because stomach and gallbladder are anatomically adjacent, gastric dis- tension can obstruct the operator’s field of vision and interfere with surgical manipulation, which makes it imperative to lower the incidence and intensity of gastric distension. The eectiveness of supraglottic airway during laparoscopic cholecystectomy has been studied in terms of gastric insuations and distension. 11–13 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 chol- ecystectomy. SLIPA was compared with LMA ProSeal on gastric distension only in lower abdominal laparoscopic surgery 6,8 and ill-defined surgeries (requiring supine posi- tion during operation). 5 In addition, although SLIPA oered the advantage of less perilaryngeal gas leakage and a similar incidence of gastric insuations compared with LMA ProSeal in previous studies, 5,6,8 the results did not include quantitative measurement regarding gastric dis- tension, which make it more dicult to determine dier- ences in gastric distension than when using quantitative measurements in laparoscopic cholecystectomy. Accord- ingly, 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 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 Anesthesi- ology 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: [email protected]). Copyright r 2014 by Lippincott Williams & Wilkins ORIGINAL ARTICLE 216 | www.surgical-laparoscopy.com Surg Laparosc Endosc Percutan Tech Volume 24, Number 3, June 2014

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Page 1: Gastric Distension With SLIPA Versus LMA ProSeal During Laparoscopic Cholecystectomy: A Randomized Trial

Gastric Distension With SLIPA Versus LMA ProSeal DuringLaparoscopic Cholecystectomy: A Randomized Trial

Su Man Cha, MD,* Sihyun Park, RN, MSN,w Hyun Kang, MD, PhD,zyChong Wha Baek, MD, PhD,z Yong Hun Jung, MD, PhD,zYoung Joo Cha, MD, PhD,y8 and Junyong In, MD, PhDz

Background: We compared the quantitative clinical performancesof the streamlined liner of the pharynx airway (SLIPA) and theProSeal laryngeal mask airway (LMA ProSeal) regarding intensityof gastric distension in patients undergoing laparoscopiccholecystectomy.

Methods: A total of 124 anesthetized, paralyzed patients (ASA 1 to2; aged, 18 to 80 y) were randomly allocated for airway manage-ment with the SLIPA or LMA ProSeal. After induction of generalanesthesia using total intravenous anesthesia and rocuronium, theintensity of gastric distension was accessed twice by 2 raters,respectively. We also compared the fiberoptic bronchoscopic viewof the glottis, the severity of blood stain, and postoperative sorethroat.

Results: There were no statistically significant di!erences betweengroups for each gastric size. The change of gastric size within theSLIPA 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 ofblood stain and postoperative sore throat were similar in bothgroups.

Conclusions: SLIPA is as e"cacious as LMA ProSeal for use inpatients without severe complications who are undergoing lapa-roscopic cholecystectomy.

Key Words: gastric distension, laparoscopic cholecystectomy, lar-yngeal mask airway, SLIPA

(Surg Laparosc Endosc Percutan Tech 2014;24:216–220)

The streamlined liner of the pharynx airway (SLIPA;SLIPA Medical Ltd, London, UK) is becoming recog-

nized as a safe and e!ective supraglottic airway for airwaymanagement during surgery.1–10

In laparoscopic cholecystectomy, because stomachand gallbladder are anatomically adjacent, gastric dis-tension can obstruct the operator’s field of vision andinterfere with surgical manipulation, which makes itimperative to lower the incidence and intensity of gastricdistension. The e!ectiveness of supraglottic airway duringlaparoscopic cholecystectomy has been studied in terms ofgastric insu#ations and distension.11–13 Such studiesreported that the classical laryngeal mask airway (LMAClassic) and the ProSeal laryngeal mask airway (LMAProSeal; Laryngeal Mask Company, Henley-on-Thames,UK) were comparable to an endotracheal tube regardingthe change in gastric distension during laparoscopiccholecystectomy.

However, to the best of our knowledge, there is nostudy concerning the use of SLIPA in laparoscopic chol-ecystectomy. SLIPA was compared with LMA ProSeal ongastric distension only in lower abdominal laparoscopicsurgery6,8 and ill-defined surgeries (requiring supine posi-tion during operation).5 In addition, although SLIPAo!ered the advantage of less perilaryngeal gas leakage anda similar incidence of gastric insu#ations compared withLMA ProSeal in previous studies,5,6,8 the results did notinclude quantitative measurement regarding gastric dis-tension, which make it more di"cult to determine di!er-ences in gastric distension than when using quantitativemeasurements in laparoscopic cholecystectomy. Accord-ingly, we developed a new quantitative tool to measureseverity of gastric distension.

The aim of this study was to compare the quantitativeclinical performance of the SLIPA with the LMA ProSealwith regard to intensity of gastric distension when used inpatients undergoing laparoscopic cholecystectomy. We alsocompared fiberoptic view of the glottis, complicationsduring emergence, and the severity of blood stain andpostoperative sore throat.

METHODSThe study protocol was approved by the Institutional

Review Board of Chung-Ang University School ofMedicine [c2011091 (541)] and the study is registered withthe Australian New Zealand Clinical Trials Registry(ACTRN12611001189910) (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=347718). This study wascarried out according to the principles of the Declaration ofHelsinki (2000) and written informed consent was obtainedfrom all patients.

We recruited 124 healthy (ASA 1 to 2) individuals,aged 18 to 80 years, who required elective laparoscopiccholecystectomy and were eligible for enrollment in thestudy. We excluded patients with a history of diabetes

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 Anesthesi-ology and Pain Medicine; 8Department of Laboratory Medicine;yMedical Device Clinical Trials Center, College of Medicine,Chung-Ang University, Seoul; zDepartment of Anesthesiology andPain Medicine, Ilsan Hospital, Dongguk University MedicalCenter, Goyang, Republic of Korea; and wSchool of Nursing,University of Washington, Seattle, WA.

Supported by a grant of the Korea Healthcare Technology R&DProject, 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, 224-1Heukseok-dong, Dongjak-gu, Seoul 156-755, Korea (e-mail:[email protected]).

Copyright r 2014 by Lippincott Williams & Wilkins

ORIGINAL ARTICLE

216 | www.surgical-laparoscopy.com Surg Laparosc Endosc Percutan Tech ! Volume 24, Number 3, June 2014

Page 2: Gastric Distension With SLIPA Versus LMA ProSeal During Laparoscopic Cholecystectomy: A Randomized Trial

mellitus, gastroesophageal reflux, other neurological ormusculoskeletal diseases, obesity (body mass index >30 kg/m2), or with features or history of a di"cult airway. Thedecision to enroll was made by one author who did nototherwise participate in this study. The patients were ran-domly divided into a SLIPA (n=62) and a LMA ProSeal(n=62) group. Randomization into 1 of the 2 groups wasbased on random table generated using R-program. Blockrandomization with a block size of 4 or 6 and equal allo-cation was used to prevent imbalances in treatmentassignments. The randomization sequence was generated bya statistician who is not involved with the study. Patientgroup allocation was revealed to the investigator immedi-ately before induction of anesthesia by means of numbered,sealed envelopes.

One anesthesiologist with >4 years of experience withairway management using LMA ProSeal and with >1 yearof experience with SLIPA was selected to administersupraglottic airway for this study. A second anesthesiolo-gist recorded data as an independent observer.

No premedication was given. After placement ofstandard monitoring systems (electrocardiography, non-invasive arterial blood pressure sensing, and pulse oxime-try) and BIS monitoring system and preoxygenation for3 minutes, lidocaine (0.5mg/kg) was administrated intra-venously to prevent propofol injection pain. Propofol wasstarted at a plasma concentration of 3 to 4mg/mL withremifentanil (4 to 6 ng/mL). Rocuronium (0.6mg/kg) wasgiven when the patient lost consciousness. Ventilation wascontrolled through a facemask with 100% O2. To avoidgastric insu#ation, the lungs were gently ventilated withmaintaining adjustable pressure-limiting valve at 15 cmH2O until su"cient jaw relaxation.

When the jaw was su"ciently relaxed, the SLIPA orLMA ProSeal was inserted. In the SLIPA group, size waschosen by the width across the thyroid cartilage.3 In theLMA ProSeal group, size 3 was used for patients weighing<50 kg, size 4 for those weighing 50 to 70 kg, and size 5 forthose >70 kg according to the manufacturer’s recom-mendations. Normal saline was used for lubrication in bothsupraglottic airways. After insertion, the cu! in the LMAProSeal group was maintained <60 cm H2O with a handpressure gauge (Cu! pressure gauge; VBM Medi-zinetechnik GmbH, Sulz, Germany).

If the initial attempt at insertion into the pharynx wasunsuccessful, a second attempt at insertion was made usinga supraglottic airway of smaller size, respectively. If thesecond attempt at insertion was unsuccessful, it wasrecorded as an insertion failure and the supraglottic airwaywas shifted with endotracheal tube.

After a successful insertion, ventilator parameters wereset at a tidal volume 10mL/kg of the patient’s ideal bodyweight,14 respiratory rate of 10 breaths/min, and aninspiratory-to-expiratory ratio of 1:2 using a volume-con-trolled ventilator (Datex-Ohmeda Aestiva/5 ventilator; GEHealth Care, Madison, WI). We considered that e!ectiveventilation was achieved when a square wave capnographtrace was obtained and audile leakage did not develop.Although airway insertion was successful, if appropriatecapnograph could not be obtained until the fifth mech-anical ventilation or an audible leakage developed, weregard it as ine!ective ventilation and tried manipulation toadjust the supraglottic airway. In the SLIPA group, werepositioned the device. In the LMA ProSeal group, up to10mL of air was added in the LMA ProSeal cu! at

maximal 60 cm H2O with a hand pressure gauge, but if theproblem persisted in the LMA ProSeal, we repositionedafter deflating a cu!. If e!ective ventilation still could notbe achieved through repositioning on 2 groups, the devicewas completely removed in preparation for supraglotticairway of larger size. If e!ective ventilation could not beachieved with a larger size supraglottic airway, equalmanipulation that was tried to adjust the supraglotticairway before the decision of device change was performedfor correction. However, if the correction was still note!ective, it was recorded as an e!ective ventilation failureand the supraglottic airway was changed to an endotrachealtube.

After SLIPA or LMA ProSeal insertion, respiratoryrate was adjusted according to the range of end tidal CO2

(30 to 35mm Hg). The inspired oxygen fraction was 0.5with air while maintaining a fixed fresh gas flow of 3L/min.If 4 twitches were observed before removal of gallbladderwhile monitoring train-of-four in the adductor pollicismuscle, additional rocuronium (0.1mg/kg) was adminis-tered. If >10% di!erence existed between the inspirationand expiration tidal volume on spirometry (S/5TM Compactanesthesia monitor; Datex-Ohmeda, Tewksbury, MA) atany time during the operation except during positionchange and the start or finish of pneumoperitoneum, weattempted same manipulation to adjust the supraglotticairway. However, if equal manipulation was not e!ective, itwas recorded as maintenance failure and the supraglotticairway was changed to an endotracheal tube.

Anatomic fit was checked using a flexible fiberopticbronchoscope (Olympus BF-3C40; Olympus Optical,Tokyo, Japan) and this was graded by a second anesthesi-ologist. The fiberoptic view was assessed by the gradingsystem of Joshi et al15: grade 1, vocal cords not seen; grade2, vocal cords plus the anterior epiglottis seen; grade 3,cords plus the posterior epiglottis seen; and grade 4, onlyvocal cords seen.

Peritoneal insu#ations pressure was maintained at15mm Hg using CO2. After the patient was placed inreverse Trendelenburg position (30 degrees) and tilteddownward to the patient’s left (10 degrees), the surgeon,who did not know which supraglottic airway was used,assigned a gastric distension score by using a direct visu-alizing laparoscope (pregastric distension score). Before theCO2 was evacuated and patient position changed at the endof surgery, the surgeon again assigned a gastric distensionscore (postgastric distension score). The scores of all caseswere assessed by the same surgeon (rater 1). The gastricdistension score scale ranged from 0 to 10 (Fig. 1). Anindependent examiner (rater 2) evaluated gastric distensionscores through recorded screen on a separate workstationwithout any prior knowledge of the patient’s history orsurgery. In addition, we defined the gastric distension score>5 as manipulation-needed case, of which the incidenceswere evaluated.

At the end of the operation, neostigmine and glyco-pyrrolate were given to reverse neuromuscular block. Thesupraglottic airway was removed when the patient resumedspontaneous breathing (when the VT reached 8mL/kg andthe patient was able to obey commands) and it wasinspected for the presence of visible regurgitant or anyblood. Any breathing problems were recorded in emergence(including cough, vomiting, laryngospasm, or need forpositive ventilation or airway intervention). One blindedinvestigator collected the postoperative sore throat score at

Surg Laparosc Endosc Percutan Tech ! Volume 24, Number 3, June 2014 SLIPA and LMA-P in Laparoscopic Cholecystectomy

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30 minutes and 1 day after emergence (none, mild, mod-erate, and severe).

The primary outcome measurement of the study wasthe comparison of the degree of gastric distension between2 groups at the end of surgery (postgastric distension score).Additional analyses were performed with regard to pre-gastric distension score, anatomic fit, any problems duringemergence, and the severity of blood stain and post-operative sore throat.

Sample Size Calculation and StatisticsTo estimate the group size, a pilot study was con-

ducted for measuring the degree of gastric distension at theend of surgery (postgastric distension score) in 20 patients(10 in LMA-Proseal and 10 in SLIPA). Postgastric dis-tension score of pilot study was normally distributed, andits mean and SD of the postgastric distension score forLMA Proseal and SLIPA were 3.7 (1.9) and 2.6 (1.1),respectively. We wanted the capability to show a di!erenceof 1 in the gastric distention score between the groups. Witha=0.05, 2-tailed and a power of 90%, we required 54patients per group.

Considering the patient insertion failure rate, e!ectiveventilation failure, and maintenance failure rate of 9%, 2%,and 2%, respectively, we required 124 patients for thestudy.

For intergroup comparisons, the distributions of thedata were first evaluated for normality using the Shapiro-Wilk test. The normally distributed data are presented asthe mean (SD), and groups were compared using unpairedthe Student t tests. The non-normally distributed data areexpressed as medians (interquartile range) and they were

analyzed using the Mann-Whitney U test. The Wilcoxonsigned-rank test was used to compare pregastric and post-gastric distension scores, and the Spearman r was com-puted to determine the reliability of interrater agreement.

Descriptive variables were subjected to w2 analysis orthe Fischer exact test, as appropriate, and P-values <0.05were considered statistically significant. Statistical analysiswas performed using SPSS ver. 18.0 (SPSS Inc., Chicago,IL).

RESULTSA 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 theLMA ProSeal group. Regarding e!ective ventilation fail-ure, 1 patient was excluded in the SLIPA group and 3patients were excluded in the LMA ProSeal group.Regarding maintenance failure, 3 patients in the SLIPAgroup and 3 patients in the LMA ProSeal group wereexcluded from analysis. One patient in the SLIPA groupwas excluded from analysis due to conversion to an openmethod by severe adhesion.

Data were analyzed from 112 patients. Demographicdata, anesthesia, and pneumoperitoneum time were similarfor both groups (Table 1).

There was no statistically significant di!erencebetween groups for pregastric and postgastric distensionscores. The change from pregastric distension score topostgastric distension score in the SLIPA group was notstatistically significant for both raters. The change in the

FIGURE 1. The gastric distension score scale.

TABLE 1. Demographic Data

LMA ProSeal(n=56)

SLIPA(n=56) P

Age (y) 45.50 (34.00-54.75) 41.00 (33.00-51.75) 0.547Sex: M/F (n) 29/27 27/29 0.705Height (cm) 160.43±9.89 162.89±7.12 0.134Weight (kg) 61.20±13.93 64.43±10.33 0.166ASA grade 1, 2 (n) 39/17 42/14 0.526SizeLMA ProSeal: 3/4/5 (n) 10/30/16 —SLIPA: 49/51/53 (n) — 24/5/21

Anatomic fitI/II/III/IV (n) 0/2/10/44 0/4/11/41 0.664

Duration of Ane (min) 74.00 (61.25-88.75) 75.00 (65.25-95.00) 0.341Duration of Pn (min) 46.00 (36.00-63.50) 50.00 (41.00-66.75) 0.180

Values are expressed as mean±SD, median (interquartile range), or absolute number.No significant di!erences 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.

Cha et al Surg Laparosc Endosc Percutan Tech ! Volume 24, Number 3, June 2014

218 | www.surgical-laparoscopy.com r 2014 Lippincott Williams & Wilkins

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LMA ProSeal group was not statistically significant forrater 1 but was significant for rater 2 (Table 2). Interrateragreement was strongly associated with pregastric dis-tension score (r=0.619, P<0.001) and fairly associatedwith postgastric distension score (r=0.568, P<0.001).

The incidences of manipulation-needed case weresimilar between groups, and between pregastric and post-gastric scores in each groups (Table 3).

Anatomic fit, complications during emergence, and theseverity of blood stain and postoperative sore throat weresimilar in both groups (Table 4).

DISCUSSIONThis is the first study showing the clinical e"cacy of

SLIPA during laparoscopic cholecystectomy and includingquantitative measurement for gastric distension during useof supraglottic airway.

Because gastric distension can induce gastric perfo-ration during insertion of a laparoscope16 and interfere withsurgical field and manipulation, lower incidence of gastricinsu#ation and intensity of gastric distension are importantin laparoscopic cholecystectomy. Therefore, the incidenceof gastric insu#ations and intensity of gastric distensionduring use of a newly developed airway device should bechecked to reduce operation time and complications inlaparoscopic cholecystectomy.

Maltby et al11 reported that gastric distension whenusing a correctly seated LMA Classic of appropriate sizeoccurred with equal frequency with endotracheal tube duringlaparoscopic cholecystectomy. In addition, Maltby et al12 and

Lu et al13 reported that a correctly seated LMA ProSealprovided e!ective ventilation without clinically significantgastric distension during laparoscopic cholecystectomy.

However, there is no study concerning the use of SLIPAin laparoscopic cholecystectomy. Unlike the LMA ProSealthat has a cu! with which can correct the sealing by addingair when perilaryngeal leakage develop, due to fixed shape ofSLIPA, there is a limit to correction of SLIPA in situationsinvolving inappropriate position and perilaryngeal leakage.Therefore, the risk of gastric distension and inadequateventilation when using a SLIPA during pneumoperitoneumseems to be greater than when using a LMA ProSeal.

However, our results demonstrate that SLIPA can beused as e!ective as LMA ProSeal and without severecomplications in laparoscopic cholecystectomy. AlthoughSLIPA was studied only for the incidence of gastric insuf-flations and using a qualitative measure of gastric dis-tension in previous studies, our results supported the pre-vious studies, which showed there was no statisticallysignificant di!erence in the incidence of gastric insu#ationswhen using SLIPA and LMA ProSeal.5,6,8

In our results, there were no statistically significantdi!erences between groups for pregastric and postgastricdistension size, and the change from pregastric to post-gastric distension score in LMA ProSeal for rater 2 wasstatistically significant and the change for rater 1 wasmarginally significant. Furthermore, the incidences ofmanipulation-needed case were similar between groups andbetween pregastric and postgastric distension scores.Accordingly, SLIPA seems to be as e!ective as LMAProSeal, when used in laparoscopic cholecystectomy.

TABLE 2. Gastric Distension Score

G score LMA ProSeal (n=56) Pre-Post SLIPA (n=56) Pre-Post Between Groups

R1 0.056 0.543Pre-G 2.00 (2.00-3.00) 2.00 (2.00-3.00) 0.889Post-G 2.00 (2.00-4.00) 2.00 (1.00-3.00) 0.050

R2 0.045* 0.856Pre-G 2.00 (1.00-3.00) 2.00 (2.00-3.00) 0.647Post-G 3.00 (2.00-4.00) 2.00 (2.00-3.00) 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 di!erences 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; pre-

post, change from pregastric to postgastric distension score; R1, rater 1; R2, rater 2; SLIPA, streamlined liner of the pharynx airway.

TABLE 3. Manipulation-needed Case

LMA ProSeal (n=56) Pre-Post SLIPA (n=56) Pre-Post Between Groups

R1 [n (%)] 1.000 1.000Pre-G 3 (5.4) 1 (1.8) 0.618Post-G 3 (5.4) 2 (3.6) 1.000

R2 [n (%)] 1.000 1.000Pre-G 1 (1.8) 0 (0) 1.000Post-G 1 (1.8) 1 (1.8) 1.000

Values are expressed as absolute number (%).Data were analyzed using the Fisher exact test.No significant di!erences 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; pre-

post, change from pregastric to postgastric distension score; R1, rater 1; R2, rater 2; SLIPA, streamlined liner of the pharynx airway.

Surg Laparosc Endosc Percutan Tech ! Volume 24, Number 3, June 2014 SLIPA and LMA-P in Laparoscopic Cholecystectomy

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Unlike previous studies, our results were obtainedusing quantitative measurements. We used gastric dis-tension scores ranging from 0 to 10 for evaluation of gastricdistension. We established guidelines through surgeon’sassessment or manipulation regarding gastric distension formaintaining quality of our gastric distension score. In ane!ort to standardize, the surgeon had undergone a processof adaptation to gastric distension score. Because our gas-tric distension score was based on the surgeon’s assessmentof the di"culty of the operation, this score did not indicatethe exact volume of gastric distension. However, this scoremay be able to represent not only an approximate volumebut also provide a practical assessment of gastric distensionduring laparoscopic cholecystectomy. For obtaining reli-ability, our results went through a process of rescoring byanother investigator. Interrater agreement was stronglyassociated for the pregastric distension score (r=0.619,P<0.001) and fairly associated for the postgastric dis-tension score (r=0.568, P<0.001).

Pregastric distension score exceeding 3 were approx-imately 30%, which score indicating mild distension andsurgeon careful to distension. Our long ventilation timebefore insertion of supraglottic airway and manipulation tocorrect the airway may have influenced these results. Thisscore may not be regarded by some surgeons as a properscore for starting an operation. However, there were nocases requiring decompression to proceed with surgery.

Our study has a number of limitations. First, theduration of pneumoperitoneum was <1 hour in most of thecases. The results cannot be directly extrapolated to use ofthe supraglottic airway in operations of longer duration.Second, due to our exclusion guidelines, the results cannotbe extrapolated to all patients. Third, the size in the SLIPAgroup was chosen by width across the thyroid cartilage.3 Ifpatient 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 di!erent. Fourth, the methodof assessing the position of the supraglottic airway using afiberoptic bronchoscope15 may not be valid for the SLIPA.

To the best of our knowledge, there is no particular studyconcerning the assessment of the position of SLIPA. How-ever, anatomic fit was similar in both groups using thisassessment in our study.

In conclusion, the SLIPA can be used as e"caciously asLMA ProSeal without severe gastric distension and sig-nificant complications during laparoscopic cholecystectomy.

REFERENCES

1. Miller DM, Light D. Laboratory and clinical comparisons ofthe Streamlined Liner of the Pharynx Airway (SLIPA) with thelaryngeal mask airway. Anaesthesia. 2003;58:136–142.

2. Hein C, Plummer J, Owen H. Evaluation of the SLIPA(streamlined liner of the pharynx airway), a single use supraglotticairway device, in 60 anaesthetized patients undergoing minorsurgical procedures. Anaesth Intensive Care. 2005;33:756–761.

3. Miller DM, Camporota L. Advantages of ProSeal and SLIPAairways over tracheal tubes for gynecological laparoscopies.Can J Anaesth. 2006;53:188–193.

4. Lange M, Smul T, Zimmermann P, et al. The effectiveness andpatient comfort of the novel streamlined pharynx airway liner(SLIPA) compared with the conventional laryngeal maskairway in ophthalmic surgery. Anesth Analg. 2007;104:431–434.

5. Choi YM, Cha SM, Kang H, et al. The clinical effectiveness ofthe streamlined liner of pharyngeal airway (SLIPA) comparedwith the laryngeal mask airway ProSeal during generalanesthesia. Korean J Anesthesiol. 2010;58:450–457.

6. Abdellatif AA, Ali MA. Comparison of streamlined liner of thepharynx airway (SLIPA) with the laryngeal mask airwayProseal for lower abdominal laparoscopic surgeries in para-lyzed, anesthetized patients. Saudi J Anaesth. 2011;5:270–276.

7. Hong SJ, Ko KM, Park JH, et al. Effectiveness of theStreamlined Liner of the Pharynx Airway (SLIPATM) inallowing positive pressure ventilation during gynaecologicallaparoscopic surgery. Anaesth Intensive Care. 2011;39:618–622.

8. Woo YC, Cha SM, Kang H, et al. Less perilaryngeal gas leakagewith SLIPA than with LMA-ProSeal in paralyzed patients. CanJ Anaesth. 2011;58:48–54.

9. Miller D. Laryngeal mask airway classic and streamlinedpharynx airway liner airway comparison. Anesth Analg. 2007;105:1508.

10. Xu J, Zhong TD. Comparison and superiority of streamlinedliner of the pharynx airway to laryngeal mask airway ortracheal tubes for gynecological laparoscopy. Zhonghua yi xueza zhi. 2010;90:49–52.

11. Maltby JR, Beriault MT, Watson NC, et al. Gastric distensionand ventilation during laparoscopic cholecystectomy: LMA-Classic versus tracheal intubation. Can J Anaesth. 2000;47:622–626.

12. Maltby JR, Beriault MT, Watson NC, et al. The LMA-ProSealis an effective alternative to tracheal intubation for laparo-scopic cholecystectomy. Can J Anaesth. 2002;49:857–862.

13. Lu PP, Brimacombe J, Yang C, et al. ProSeal versus the classiclaryngeal mask airway for positive pressure ventilation duringlaparoscopic cholecystectomy. Br J Anaesth. 2002;88:824–827.

14. Keller C, Brimacombe JR, Keller K, et al. Comparison of fourmethods for assessing airway sealing pressure with thelaryngeal mask airway in adult patients. Br J Anaesth. 1999;82:286–287.

15. Joshi S, Sciacca RR, Solanki DR, et al. A prospectiveevaluation of clinical tests for placement of laryngeal maskairways. Anesthesiology. 1998;89:1141–1146.

16. Whitford JH, Gunstone AJ. Gastric perforation: a hazard oflaparoscopy under general anaesthesia. Br J Anaesth. 1972;44:97–99.

TABLE 4. Postoperative Complication

LMA ProSeal(n=56)

SLIPA(n=56) P

Sore throat at PACUNone/mild/moderate/severe

28/23/3/2 22/18/10/6 0.069

Sore throat at POD1None/mild/moderate/severe

43/12/0/1 35/17/4/0 0.083

Blood tingedNone/mild/moderate/severe

49/3/4 45/8/3 0.274

Any complication onemergence

56/0 55/1* 0.315

Values are expressed as absolute number.No significant di!erences between groups.*Laryngospasm.LMA ProSeal indicates ProSeal layngeal mask airway; PACU, post-

anesthetic care unit; POD1, post-operative day 1; SLIPA, streamlined linerof the pharynx airway.

Cha et al Surg Laparosc Endosc Percutan Tech ! Volume 24, Number 3, June 2014

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