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Anesth Analg 2007;104:431-434
© 2007 International Anesthesia Research Society
doi: 10.1213/01.ane.0000252460.94046.7c


GENERAL ARTICLES

The Effectiveness and Patient Comfort of the Novel Streamlined Pharynx Airway Liner (SLIPA®) Compared with the Conventional Laryngeal Mask Airway in Ophthalmic Surgery

Markus Lange, MD, Thorsten Smul, MD, Peter Zimmermann, MD, Rudolf Kohlenberger, MD, Norbert Roewer, MD, PhD, and Franz Kehl, MD, PhD, DEAA

From the Department of Anaesthesia and Critical Care, University of Würzburg, Würzburg, Germany.

Address correspondence and reprint requests to Franz Kehl, MD, PhD, DEAA, Universität Würzburg, Klinik und Poliklinik für Anästhesiologie, Zentrum Operative Medizin, Oberdürrbacher St. 6, 97080 Würzburg, Germany. Address e-mail to franz.kehl{at}mail.uni-wuerzburg.de.


    Abstract
 Top
 Abstract
 Introduction
 METHODS
 RESULTS
 DISCUSSIONS
 REFERENCES
 
BACKGROUND: The novel, disposable streamlined pharynx airway liner (SLIPA®) has recently been introduced into clinical practice. It has no inflatable cuff, because the shape of the SLIPA® closely resembles the anatomy of the pharynx.

METHODS: We compared the SLIPA® with the conventional laryngeal mask airway (LMA®) regarding handling, safety, sealing of the pharynx, and patient comfort in 124 adult patients (ASA I–III) undergoing ophthalmic surgery under general anesthesia.

RESULTS: Insertion of the SLIPA® was straightforward in 88%, slightly difficult in 10%, and obviously difficult in 0% of cases. The SLIPA® could not be inserted in 2% of patients. In the LMA® group, insertion was straightforward in 90%, slightly difficult in 8%, obviously difficult in 2%, and a failure in 0% of patients. Maximum seal pressure was 24 ± 6 mm H2O with the SLIPA® and 24 ± 4 mm H2O with the LMA®. Gastric air insufflation was noticed in 19% of patients in the SLIPA® group and 3% in the LMA® group (P < 0.05). No regurgitation of gastric contents was observed. Removal of the airway was uneventful in all cases. Blood traces were noted on the surface of the device in 20% in the SLIPA® versus 11% (n.s.) in the LMA® group. Complaints of a sore throat were recorded in 2% vs. 14% in the SLIPA® and the LMA® group, respectively.

CONCLUSION: The SLIPA® is a useful alternative to the conventional LMA® in patients undergoing minor surgery. However, it is associated with a higher incidence of gastric air insufflation, which may increase the risk of aspiration.


    Introduction
 Top
 Abstract
 Introduction
 METHODS
 RESULTS
 DISCUSSIONS
 REFERENCES
 
The conventional reusable laryngeal mask airway (LMA®) was developed and introduced in the early 1980s (1). The LMA® is used in a wide range of patients and surgical procedures. Hygienic concerns (2–4) and the costs for the reusable conventional LMA®, including the lifecycle cost for repeated cleaning and sterilizing, have led to the development of disposable supralaryngeal airways (5). The streamlined pharynx airway liner (SLIPA®) is a new, single-use, supraglottic airway device made of soft plastic. This SLIPA® has a boot shape that resembles the anatomy of the pharynx. The SLIPA® contains a collection chamber to capture regurgitated liquids and potentially reduce the risk of aspiration (Fig. 1) (6). As the SLIPA® has no inflatable cuff, it may be less expensive to produce than an LMA®. However, the absence of an inflatable cuff may result in an increased risk of gastric insufflation, and requires precise selection of the appropriate size by the anesthesiologist. We compared the SLIPA® with the conventional LMA® in patients undergoing ophthalmic surgery.


Figure 135
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Figure 1. The SLIPA® is made of soft hollow plastic and comprises a shaft and a body with an anterior hole. The prominences of the body are referred to as toe, heel, and bridge. Because the SLIPA® resembles the anatomy of the pharynx, an inflatable cuff is unnecessary. Instead, the body serves as a reservoir for regurgitated liquids.

 


    METHODS
 Top
 Abstract
 Introduction
 METHODS
 RESULTS
 DISCUSSIONS
 REFERENCES
 
The study protocol was approved by the IRB. All patients gave written informed consent. Patients who presented for ophthalmic surgery were eligible for participation in the study when they were ≥18 yr of age, ASA physical status I–III, with a body mass index less than or equal to 35 kg/m2. Exclusion criteria were contraindications for the use of a laryngeal airway device, a history of gastroesophageal reflux, current sore throat, dysphagia, and pregnancy. All physicians inserting the supraglottic airway devices had a minimum of 3 yr experience in anesthesia and airway management with LMAs. Patients were randomly assigned to receive either the SLIPA® (Teleflex Medical, Kernen, Germany) or a conventional LMA® (LMA Deutschland, Bonn, Germany). Choice of the appropriate size of the airway device used was left to the anesthesiologist's discretion. Sizes of the SLIPA® and the LMA® used ranged from 47 to 57 and from 4 to 6, respectively.

After standard monitoring (electrocardiogram, noninvasive arterial blood pressure measurement, and pulse oximetry) had been established and administration of 100% oxygen was accomplished, anesthesia was induced with propofol 2–3 mg/kg and remifentanil 0.5 µg/kg IV and maintained by continuous infusion of propofol 4–6 mg · kg–1 · h–1 and remifentanil 0.2 µg · kg–1 · min–1. Neuromuscular blockade was not used in any study patient. Adequate depth of anesthesia was verified by clinical assessment. Additional bolus injections of propofol were administered as required to achieve a sufficient depth of anesthesia.

The airway device was introduced into the pharynx approximately 2 min after induction of anesthesia. Normal saline solution was used as a lubricant for both devices. Insertion was rated as "straightforward" (insertion succeeded on the first attempt, and within 15 s), "slightly difficult" (insertion success on first attempt, but required longer than 15 s), "obviously difficult" (more than one attempt before successful insertion), or "failure" (insertion not possible despite multiple attempts). If failure occurred, a single attempt to introduce the alternative supraglottic airway device into the pharynx was performed. If this attempt failed, endotracheal intubation was performed. Insertion time was the time from jaw opening to successful placement of the airway device, verified by sufficient ventilation (≥6 mL/kg) and normal capnogram.

If a LMA® was used, the cuff was inflated with 20 mL of air after successful placement. If substantial leakage occurred despite optimal placement of the LMA®, another 10 mL of air was added. The cuff pressure was then maintained constantly at 20 cm H2O by manometric control. If the chosen size of the SLIPA® or the LMA® proved too small to attain an adequate seal, the airway device was replaced by a different size. Exchange of the airway was noted and insertion time of the correctly sized airway device was included in the evaluation.

Maximum airway sealing pressure was measured by closing the expiratory valve of the breathing circuit and noting the pressure at which a leak developed with a fixed fresh gas flow of 3l/min (7). Patients' lungs were ventilated using pressure-controlled mode below maximum sealing pressure with a minute ventilation of 80 mL · kg–1 · min–1. Controlled ventilation was performed in all patients throughout the operation. Gastric air insufflation was monitored repeatedly by auscultation using a stethoscope positioned over the patient's stomach, immediately after insertion of the airway, after positioning, and at the end of surgery. All surgical procedures were performed with the patients in the supine position. At the end of surgery, patients were allowed to breathe spontaneously, and the airway device was removed when tidal volume reached 8 mL/kg and the patient responded to simple verbal commands. Removal of airway devices was graded as easy or difficult. Patients were interviewed by an independent investigator 30 min after arrival in the postanesthesia care unit to determine if they had a sore throat. A visual analog scale was used to rate soreness of the throat from 0 to 10.

Continuous data were tested for normal distribution and analyzed by Student's t-test. Noncontinuous data were analyzed by {chi}2 test and Mann–Whitney U-test test, where appropriate. Data are expressed as mean ± sem where applicable. P < 0.05 was considered statistically significant.


    RESULTS
 Top
 Abstract
 Introduction
 METHODS
 RESULTS
 DISCUSSIONS
 REFERENCES
 
We studied 124 consecutive patients (64 men, 60 women) with ASA physical status I–III presenting for ophthalmic surgery. Data from all patients were included in the analysis. There were no differences between groups with respect to age, gender, or height. The patients of the LMA® group had a slightly higher body mass index (Table 1). Sixty-five patients were randomized to LMA® and 59 patients were randomized to SLIPA® (Table 2).


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Table 1. Patient Characteristics

 

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Table 2. Results

 

The rate of successful insertion was 98% (n = 58) and 100% (n = 65) in the SLIPA® and the LMA® groups, respectively. In the SLIPA® group, insertion of the airway device was rated straight forward in 88% (n = 52), slightly difficult in 10% (n = 6), obviously difficult in 0%, and failure in 2% of patients (n = 1). In the LMA® group, insertion was straightforward in 90% (n = 59), slightly difficult in 8% (n = 5), obviously difficult in 2% (n = 1), and failure in 0% of patients. In the single failure case in the SLIPA® group, the SLIPA® was replaced by a LMA®. No patients required endotracheal intubation. The airway was replaced by a smaller device in three patients in the SLIPA® group and in two patients in the LMA® group. The airway was replaced by a larger device in two patients in the SLIPA® group and in one patient in the LMA® group. Maximum airway sealing pressure was 24 ± 6 mm H2O and 24 ± 4 mm H2O in the SLIPA® and the LMA® groups, respectively. Gastric air insufflation occurred significantly more often in the SLIPA® group (19%, n = 11) than in the LMA® group (3%, n = 2). No regurgitation of gastric contents was observed in any patient. Removal of the SLIPA® or the LMA® was uneventful in all cases. Blood traces were noticed on the surface of the device in 20% (n = 12) of the SLIPA® group and in 11% (n = 7) of the LMA® group. Complaints of a sore throat were noticed at a significantly higher rate in the LMA® group (14%, n = 9) than in the SLIPA® group (2%, n = 1).


    DISCUSSIONS
 Top
 Abstract
 Introduction
 METHODS
 RESULTS
 DISCUSSIONS
 REFERENCES
 
In the current study, the airway was successfully secured in 100% of patients using the LMA® and 98% using the SLIPA®. In one patient, the SLIPA® had to be removed and substituted with a LMA® due to insufficient airway sealing despite adjusted airway size. Management of the airway was comparably easy using the SLIPA® or the classic LMA®. In the majority of patients, insertion of the supraglottic airway device was successful on first attempt. These results confirm the findings of other studies reporting a first insertion success rate of 98% for the SLIPA® (8); and comparably few complications of the SLIPA® and the LMA® (6).

The current study is the first investigation to compare the current version of the SLIPA®, intended for commercial distribution, with the classic LMA® in the clinical setting. In the study by Miller and Light (6), an experimental version of the SLIPA® was used that differed markedly from the current device. Another study compared SLIPA® with the ProSeal LMA® and with endotracheal intubation, but not with the conventional LMA® (8).

Airway sealing pressures were similar in the SLIPA® and LMA® groups, in accordance with prior reports (6). This suggests that the risk of aspiration should be comparable for the two airway devices. The ProSeal LMA®, a modified version of the classic LMA® with an additional channel for gastric tube placement and a superior cuff, may provide airway sealing pressures that are higher than those of the conventional LMA® (9,10). Theoretically a supraglottic airway device with higher sealing pressures should better protect the airway from aspiration.

Pulmonary aspiration of gastric contents remains a major concern when using supraglottic airway devices (11). Although gastric air insufflation did occur at a higher rate in the SLIPA® group, no regurgitation of gastric contents was observed in either group. Whether this difference translates into a higher risk of gas extension of the stomach and higher risk of aspiration cannot be determined with the small number of patients in the available studies. The fluid collection chamber of the SLIPA® might provide some protection from aspiration of gastric contents.

The inflatable cuff of the LMA® exerts pressure on the pharyngeal structures. Several reports associate the use of the LMA® with injuries of the lingual, hypoglossal, and recurrent laryngeal nerves (12,13) and to sore throat (9,10). Blood traces on the airway device, reflecting direct trauma to pharyngeal mucosa or other structures, were found at the same rate in both groups. Although the SLIPA® is made of stiffer material than the conventional LMA®, it appears to be traumatic to the pharynx to the same degree as the LMA®.

A significantly higher rate of sore throat was noticed in the LMA® group. This might have been due to the pressure exerted on the pharynx by the inflatable cuff of the conventional LMA® (14). Soreness was predominantly mild, with only one patient in the LMA® group rating soreness >3. The incidence of sore throat is in line with other studies reporting an incidence of sore throats of 11% (15) and 27% (16) using the conventional LMA®. Interestingly, Miller and Light (6) found no difference in the rate of sore throats between the classic LMA® and the SLIPA®. However, they reported an unusually high rate of sore throats when compared with our study.

In conclusion, the SLIPA® is a useful alternative to the classic LMA® in patients undergoing minor surgery. Management of the airway with the SLIPA® was as simple as using the conventional LMA®. Although no signs of aspiration were noted in any study patient, the significantly higher rate of gastric insufflation in the SLIPA® group may have put patients at increased risk for aspiration. Fewer patients in the SLIPA® group complained of a sore throat, suggesting that the SLIPA® might increase patient comfort after minor surgery.


    Footnotes
 
Accepted for pubcliation October 13, 2006.


    REFERENCES
 Top
 Abstract
 Introduction
 METHODS
 RESULTS
 DISCUSSIONS
 REFERENCES
 

  1. Brain AIJ. The laryngeal mask–a new concept in airway management. Br J Anaesth 1983;55:801–6.[Abstract/Free Full Text]
  2. Brimacombe J, Stone T, Keller C. Supplementary cleaning does not remove protein deposits from re-usable laryngeal mask devices. Can J Anaesth 2004;51:254–7.[Abstract/Free Full Text]
  3. Coetzee GJ. Eliminating protein from reusable laryngeal mask airways. A study comparing routinely cleaned masks with three alternative cleaning methods. Anaesthesia 2003;58:346–53.[ISI][Medline]
  4. Miller DM, Youkhana I, Karunaratne WU, Pearce A. Presence of protein deposits on ‘cleaned' re-usable anaesthetic equipment. Anaesthesia 2001;56:1069–72.[ISI][Medline]
  5. Shafik MT, Bahlman BU, Hall JE, Ali MS. A comparison of the soft seal disposable and the classic re-usable laryngeal mask airway. Anaesthesia 2006;61:178–81.[ISI][Medline]
  6. Miller DM, Light D. Laboratory and clinical comparisons of the streamlined liner of the pharynx airway (SLIPA) with the laryngeal mask airway. Anaesthesia 2003;58:136–42.[ISI][Medline]
  7. Keller C, Brimacombe JR, Keller K, Morris R. Comparison of four methods for assessing airway sealing pressure with the laryngeal mask airway in adult patients. Br J Anaesth 1999;82:286–7.[Abstract/Free Full Text]
  8. Miller DM, Camporota L. Advantages of ProSealTM and SLIPATM airways over tracheal tubes for gynecological laparoscopies. Can J Anaesth 2006;53:188–93.[Abstract/Free Full Text]
  9. Brimacombe J, Keller C. The ProSeal laryngeal mask airway: a randomized, crossover study with the standard laryngeal mask airway in paralyzed, anesthetized patients. Anesthesiology 2000;93:104–9.[ISI][Medline]
  10. Brimacombe J, Keller C, Fullekrug B, et al. A multicenter study comparing the ProSeal and classic laryngeal mask airway in anesthetized, nonparalyzed patients. Anesthesiology 2002;96:289–95.[ISI][Medline]
  11. Keller C, Brimacombe J, Bittersohl J, et al. Aspiration and the laryngeal mask airway: three cases and a review of the literature. Br J Anaesth 2004;93:579–82.[Abstract/Free Full Text]
  12. Brimacombe J, Clarke G, Keller C. Lingual nerve injury associated with the ProSeal laryngeal mask airway: a case report and review of the literature. Br J Anaesth 2005;95:420–3.[Abstract/Free Full Text]
  13. Bruce IA, Ellis R, Kay NJ. Nerve injury and the laryngeal mask airway. J Laryngol Otol 2004;118:899–901.[ISI][Medline]
  14. Brimacombe J, Holyoake L, Keller C, et al. Emergence characteristics and postoperative laryngopharyngeal morbidity with the laryngeal mask airway: a comparison of high versus low initial cuff volume. Anaesthesia 2000;55:338–43.[ISI][Medline]
  15. Verghese C, Berlet J, Kapila A, Pollard R. Clinical assessment of the single use laryngeal mask airway–the LMA-unique. Br J Anaesth 1998;80:677–9.[Abstract/Free Full Text]
  16. Turan A, Kaya G, Koyuncu O, et al. Comparison of the laryngeal mask (LMATM) and laryngeal tube (LT®) with the new perilaryngeal airway (CobraPLA®) in short surgical procedures. Eur J Anaesthesiol 2006;23:234–8.[ISI][Medline]



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Lippincott, Williams & Wilkins Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999 HighWire Press