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 Table of Contents  
ORIGINAL ARTICLE
Year : 2019  |  Volume : 6  |  Issue : 2  |  Page : 182-187

Comparative study between I-Gel, ProSeal, and classical laryngeal mask airways in pediatrics: a randomized controlled trial


1 Department of Anesthesiology, Faculty of Medicine, Cairo University, Cairo, Egypt
2 Department of Anesthesiology, Faculty of Medicine, Fayoum University, Fayoum, Egypt

Date of Submission20-Oct-2017
Date of Acceptance17-Dec-2018
Date of Web Publication12-Jun-2019

Correspondence Address:
Joseph M Botros
Department of Anesthesiology, Faculty of Medicine, Fayoum University, Fayoum 11321
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/roaic.roaic_87_17

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  Abstract 

Background and objective Because the I-Gel was industrialized as a noninflatable anatomical seal of the pharynx, larynx, and paralaryngeal configuration, there could be several differences in its insertion, performance, and fiberoptic view compared with the classic laryngeal mask airway (CLMA) and the ProSeal laryngeal mask airway (PLMA). We compared the performance, including easiness of insertion, fiberoptic findings, and differences in the leak pressure among small sizes (1.5–3) with that of the CLMA and the PLMA. We anticipated the better performance of the I-Gel compared with LMA and PLMA.
Patients and methods In our study, 60 patients of both sexes, aged 5–15 years, of American Society of Anesthesiologists grades I and II, scheduled for elective surgery were randomly allocated into one of three study groups: group I (20 patients): PLMA group; group II (20 patients): CLMA group; and group III (20 patients): I-Gel laryngeal mask airway group. All patients were premedicated. Anesthetic induction was performed with inhalation of sevoflurane 4–6% or intravenous fentanyl 1 μg/kg intravenously and propofol (2.5–3 mg/kg) in children older than 5 years. After suitable depth of anesthesia, the selected device was inserted. After securing the device, a fiberoptic device was inserted through the airway device to assess the view. The airway device was removed when the patient was awakened.
Results The success rate was 100% in the three groups. There were statistically significant differences among the three groups regarding easiness of insertion, time of insertion, and insertion attempts. There were no differences in oropharyngeal leak pressure. The complications were less in I-Gel group compared with the other two groups.
Conclusion The study showed that I-Gel was easier to insert and took less time to insert than the PLMA and CLMA. The study showed that the fiberoptic view was better with the I-Gel than the PLMA and CLMA.

Keywords: fiberoptic, pediatric airway, supraglottic airway devices


How to cite this article:
ElGohary MM, Samuel EW, Botros JM. Comparative study between I-Gel, ProSeal, and classical laryngeal mask airways in pediatrics: a randomized controlled trial. Res Opin Anesth Intensive Care 2019;6:182-7

How to cite this URL:
ElGohary MM, Samuel EW, Botros JM. Comparative study between I-Gel, ProSeal, and classical laryngeal mask airways in pediatrics: a randomized controlled trial. Res Opin Anesth Intensive Care [serial online] 2019 [cited 2019 Oct 15];6:182-7. Available from: http://www.roaic.eg.net/text.asp?2019/6/2/182/260150


  Introduction Top


Pediatric airway has its special features, and its handling can constitute a real challenge. Supraglottic airway devices are now regarded as important implements in the management of pediatric airways. They are also advised by the Association of Pediatric Anaesthetists (APA) as a plan B in case of ‘Unanticipated difficult tracheal intubation − during routine induction of anesthesia in a child aged 1 to 8 years’ and as a plan C in case of ‘difficult mask ventilation − during routine induction of anesthesia in a child aged 1–8 years’ [1]. The literature is rich with experiments comparing the success, efficacy, and complications of the supraglottic airway devices commonly used in pediatrics. Nonetheless, the outcomes and deductions seem to be inconsistent. In 2004, Shimbori et al. [2] compared classic laryngeal mask airway group (cLMA) and the ProSeal laryngeal mask airway (PLMA) in pediatric practice and ended in that ease of insertion and airway sealing pressure were alike between both the groups. Another study conducted in 2014 by Saran et al. [3] compared insertion parameters, ease of gastric tube insertion, fiberoptic scoring of the glottis, airway parameters, and complications between I-Gel and PLMA in pediatrics under controlled ventilation. Outcomes displayed that I-Gel was as competent as PLMA in pediatrics in controlled ventilation [3]. Moreover, in 2012, Gasteiger et al. [4] compared size 2 LMA ProSeal versus I-Gel in nonparalyzed ventilated children and decided that oropharyngeal leak pressure and fiberoptic position of the airway device were similar for both. Furthermore, in 2012, Das et al. [5] investigated the usefulness of the size 2 I-Gel compared with PLMA and cLMA of the same size in anesthetized, paralyzed children. They ended in that hemodynamic variables, easiness of insertion, and postoperative complications were comparable among all groups, but airway sealing pressure was significantly higher in the I-Gel group [5]. In addition, the study designed by Lee et al. [6] in 2014 compared the helpfulness of I-Gel versus cLMA in small children (4–72 months old). They evaluated hemodynamic data, the success rate of insertion, airway sealing capability, and adverse events including an accidental sliding out during ventilation. They concluded that insertion success rate and oropharyngeal leak pressure of I-Gel were similar to those of cLMA. However, I-Gel was liable to unintentional sliding out of the mouth in small children [6]. On the contrary, in 2012, Lee et al. [7] performed a prospective, randomized trial comparing the I-Gel with the cLMA in children subjected to general anesthesia. They concluded that the I-Gel provided a similar leak pressure but a shorter insertion time and improved glottic view compared with the cLMA in children [7]. In 2013, Fukuhara et al. [8] compared PLMA versus I-Gel and found that fiberoptic view was significantly better with the I-Gel especially in larger children. Moreover, Mitra et al. [9] in 2012 compared PLMA versus I-Gel and found that I-Gel had higher airway leak pressures. Another study conducted by Goyal et al. [10] in 2012 compared size 2 I-Gel with PLMA and cLMA for the ease of insertion, hemodynamic effects on insertion of the device, air leak, oropharyngeal sealing pressures, and postoperative unwanted effects. Their conclusion was that pediatric size 2 I-Gel was easy to insert and provided higher oropharyngeal sealing pressure compared with same-size PLMA and cLMA in spontaneously breathing children undergoing elective surgery [10]. Fukuhara et al. [8] in 2013 compared the insertion enactment of the pediatric sizes 1.5–3 I-Gel airway device with that of the PLMA in anesthetized children in a prospective, randomized, controlled manner. They concluded that both the pediatric I-Gel and the PLMA were successfully inserted in children. The fiberoptic view was better in the I-Gel than in the PLMA [8].

We intended to choose a single device to use routinely in our hospital. However, it was a difficult choice for us to make in the light of these contradictory results. Therefore, we decided to perform this study to make our own choice considering the different population, practitioner’s skills, limited resources, and working circumstances.


  Patients and methods Top


The study was approved by the Research Ethical Committee of Fayoum University and registered in Pan African Clinical Trial Registry (identification number for the registry is PACTR201702001718176). Written consents were obtained from the parents of participating children. A total of 60 patients with American Society of Anesthesiologists physical status I and II undergoing elective surgery (30–90 min duration), in a supine position, in the period between January 2015 and June 2015, with an age range between 5 and 15 years, were enrolled in this randomized controlled study. Online randomization program (http://www.randomizer.org/) was used to allocate patients in one of the three study groups twenty (20) patients each: PLMA, cLMA (Intavent Orthofix, Maidenhead, UK) , and I-Gel (Intersurgical Ltd, Wokingham, Berkshire, UK) laryngeal mask airway group (I-Gel). The sealed envelope method was chosen to conceal this allocation. Patients with syndromes known to have a difficult airway, patients with gross upper airway pathology or anatomical anomalies, patients at risk of aspiration, and patients with a history of lung diseases were excluded from the study.

All patients were premedicated with 0.05 mg/kg IM midazolam. Standard monitoring was applied. A 22- or 24-G cannula was inserted. Induction of anesthesia was done using sevoflurane 4–6% or propofol (2.5–3) mg/kg in children older than 5 years, and fentanyl 1 μg/kg was given. After the suitable depth of anesthesia was confirmed by a central constricted pupil, jaw relaxation, and absence of movements, the selected device of an appropriate size (1.5–3) was inserted. Adequacy of ventilation was assessed by capnography, and equal adequate bilateral chest expansion by both inspection and auscultation. In case of failure to place the chosen airway device (maximum three attempts) or to adequately ventilate the patient through it, the anesthetist was allowed to manage the airway as clinically indicated. After securing the device, a fiberoptic scope was used to assess the view. Anesthesia was maintained by sevoflurane 2–4% with spontaneous ventilation. Patients were given 100% O2 during emergence, and the airway device was removed when the patient was awake. Successful attempts were recorded. The primary outcome was ease of insertion that was assessed by easy (insertion within the pharynx without resistance in the first attempt) and difficult (more than one attempt was required to seat the device within the pharynx). Number of attempts were recorded. Time needed for insertion of the airway (from the time of trial of insertion of the device to confirmation of successful ventilation by capnography) was measured. Fiberoptic view from the tip of the orifice of the device was graded from 1 to 4: score 1, only vocal cord; score 2, vocal cords plus posterior epiglottis; score 3, vocal cord plus anterior epiglottis; and score 4, vocal cord not seen, but function adequately. Oropharyngeal leak pressure (the minimum mean airway pressure at which gas leaked around the cuff of the device) was determined by closing the expiratory valve of the circle system at a fixed gas flow of 3 l/min, noting the airway pressure (maximum allowed was 40 cm H2O) at which equilibrium was reached. At this time, gas leakage was determined at the mouth (audible) and the stomach (epigastric auscultation), and the minimum airway pressure at which gas could be heard leaking was recorded. Complications were as follows: intraoperative: desaturation below 95% and inability to maintain end-tidal CO2 at 35–45 mmHg, and postoperative: hypoxia (SpO2 ≤90%), bronchospasm, airway obstruction, gastric insufflation, coughing, gagging, retching, hiccup or cough during removal, blood on device, dysphagia (difficulty or pain with swallowing), dysphonia (difficulty or pain with speaking), nausea and vomiting, and trauma of the mouth, tooth or pharynx.

Statistical analysis

Sample size calculation was done using Sealed Envelope site (http://www.sealedenvelope.com/power/binary-superiority) depending on our primary outcome is ease of insertion which is a binary variable. We found that 60 pediatric patients (20 in each group) are sufficient for 80% power (beta error 20%) and confidence interval of 95% to detect a 28% increase in the rate of ease of insertion.

Data were analyzed with Sigma Stat version 3.3 (SPSS; SPSS Inc., Chicago, Illinois, USA) and were presented as means with standard deviations, or as absolute numbers with the percentage of the whole. P less than 0.05 is considered statistically significant. Categorical data were analyzed using χ2-test and numerical parametric data were analyzed using analysis of variance test, and nonparametric data were analyzed using Kruskal–Wallis test.


  Results Top


There was no statistically significant difference between the three study groups regarding demographic data ([Table 1]). The success rate was 100% in three groups. I-Gel was significantly the easiest to insert ([Table 2]). The lowest number of insertion attempts was observed with the I-Gel group ([Table 2]). The lowest insertion time was observed with the I-Gel group, with a statistical significance ([Table 2]). The I-Gel group showed the lowest oropharyngeal leak pressure, but there was no statistically significant difference among the three groups ([Table 2]).
Table 1 Patient characteristics

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Table 2 Comparison of the performance among the three groups

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The best fiberoptic view was achieved in the I-GEL group, where 11 (55%) of 20 cases showed grade I view with I-GEL, whereas only three (15%) cases each of 20 patients in both the PLMA and CLMA groups showed grade I view. This difference was of statistical significance ([Table 3]).
Table 3 The difference of fiberoptic view

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There were no statistically significant differences in the incidence of complications in the form of blood staining of the device, dysphonia, nausea and vomiting, mouth trauma, and trauma of teeth (P>0.05) ([Figure 1]).
Figure 1 Complication in three groups. Group I: I-GEL; group II=CLMA; group III=PLMA. There was no significant difference. CLMA, classic laryngeal mask airway; PLMA, ProSeal laryngeal mask airway.

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  Discussion Top


Competent airway interference is crucial for safe management of anesthesia and successful resuscitation of cardiac arrest in patients. A new concept in the safety of airway management has escalated in the past 15 years, inferred by the introduction of new airway devices. The introduction of the LMA-Classi in 1988, followed by the LMA Fastrach and the LMA ProSeal, has generated more than 2000 publications alone [11]. Supraglottic airway devices are developed with increasing frequency following the outstanding success of the laryngeal mask airway (LMA). The PLMA and the I-Gel airway are two introduced devices for conserving the airway during controlled ventilation under general anesthesia [12]. The PLMA is a comparatively new laryngeal mask device with an altered cuff to improve the seal and a drain tube to guard against aspiration. The I-Gel is a new noninflatable, single-use supraglottic airway device for use in anesthesia during spontaneous or controlled ventilation. It is a really incomparable airway device and mirrors years of extensive research and development [13].

In our study, the three devices were successfully inserted. This agrees with Lee et al. [7] who reported that the success rate of I-Gel was comparable with that of the CLMA. Although Lee et al. noticed that the easiness of insertion of the two devices was similar, we observed that the I-Gel had the easiest insertion technique in comparison with the CLMA and PLMA. This difference might be explained by the increased difficulty with PLMA insertion, because of the larger cuff being more difficult to place in the mouth, left less room for the index finger, and was more likely to fold over. Insertion was easier with the introducer because it occupied less space than the finger, directed the cuff around the oropharyngeal inlet, and facilitated full depth of insertion. Moreover, our results were nearly similar to Das et al. [5] who reported that insertion of the I-Gel was successful on the first attempt in 28 of 30 patients and was comparable to 26 of 30 patients in the PLMA group and 27 of 30 patients in the CLMA group and very easy of insertion was 29 in the I-Gel group compared to 24 in the PLMA group and 27 in the CLMA group. Our results also are in agreement with Dwivedi et al. [14] However, despite Saran et al. [3], who compared insertion parameters, easiness of gastric tube insertion, fiberoptic scoring of the glottis, airway parameters and complications between I-Gel and PLMA in pediatrics under controlled ventilation, finding that 28 cases were easy to insert in both groups, they found that 28 case were successful in first attempt in PLMA groups compared with 26 cases of I-Gel group. This was in contrary to our outcomes, which found that easiness of insertion and success of first attempts were in favor of the I-Gel group, and they attributed that to use of different sizes of I-Gel and overlap in size selection according to body weight as recommended by the manufacturer (size 1.5: 5–12 kg and size 2: 10–25 kg) [3].

In our study, the time taken to insert I-Gel (1.30±0.66 min) was less than that to insert PLMA (2.15±1.35 min) and the CLMA (2.55±1.05 min). Theiler et al. [15] compared the I-Gel with the Ambu Aura Once (Ambu, Ball-erup, Denmark), a single-use supraglottic airway device, and found that the insertion time of the I-Gel was longer than Ambu Aura Once. In that study, however, the time required for fixation was also included in the insertion time. The shape of the Ambu Aura Once, with the cuff and the tube forming a single item with a 90° tube angle, designed to reduce stress on the upper jaw and lacking epiglottic bars, in contrast to the nonpronounced airway angle of the I-Gel and the PLMA, may also have influenced the shorter insertion time [15]. Successful insertion at the first attempt in the current study was better with the I-Gel. The least number of attempts was observed with the I-Gel group, with 80% of the I-Gel devices being inserted after the first attempt, compared with only 60% of PLMA and 40% of CLMA inserted after first attempt. However, the difference was not statistically significant. This agrees with the results of Wharton et al. [16], who showed that when the I-Gel was tested in 40 healthy anesthetized patients, the success rate on the first attempt was 82% (all devices were placed within three attempts). This agrees also with David et al. [17]. However, the insertion time in our study was longer than that taken by Saran et al. [3]. In their study, PLMA took 15±6 seconds and I-Gel 17.2±7 s, and this might be attributed to use of different sizes of I-Gel and overlap in size selection according to body weight as recommended by the manufacturer (size 1.5: 5–12 kg and size 2: 10–25 kg).

In our study, the difference between the oropharyngeal leak pressures of the three groups was statistically nonsignificant. This was in agreement with Saran et al. [3] and also Beringer et al. [18] who showed that there were no differences between the I-Gel and PLMA. In another study done by Wharton et al. [16], they found that the seal pressure of I-Gel was comparable to that of CLMA but less with PLMA. In contrast, David et al. [17] found that the mean leak on sustained pressure (with the circle gas flows of 4 l/min and the APL valve closed) was 24 cm H2O with I-Gel. This compares favorably with previous findings of 18–21 cm H2O for the CLMA and 29 cm H2O for the PLMA. Goyal et al. [10] showed that the leak pressure of the size 2 I-Gel was significantly higher than that of the size 2 PLMA. These results seem to demonstrate better fitting of the I-Gel to the airway than the PLMA. Moreover, Dwivedi et al. [14] found that the mean oropharyngeal seal pressure of I-Gel was 25.2±2.8 cmH2O for sizes 1.5, 2.0, and 2.5, which was significantly higher than PLMA 22.6±2.8 (sizes 1.5, 2, and 2.5). These results indicate that I-Gel provides better seal than same-size PLMA and CLMA (16.8±2.6).

Despite the better fiberoptic view achieved with the I-Gel more than with the PLMA and CLMA, the leak pressure of these devices was comparable. These results would suggest that the anatomical location of the I-Gel was better than that of the PLMA owing to the shape of the cuff, although the difference in location did not affect airway resistance. Previous studies comparing the leak pressure and fiberoptic view between the I-Gel and the cLMA in children and comparing these factors between the I-Gel and LMA supreme in adults have also shown that the fiberoptic view was better with the I-Gel than with the other devices, although there were no differences in the airway leak pressure between them. Besides differences between devices, our study showed that the fiberoptic view improved with the increase of sizes both the I-Gel and the PLMA; this improvement with increasing size could have resulted from the relatively longer epiglottis easily being caught and folded down or it could have been a result of the anterior and cranial position of the pediatric larynx in younger children [7]. Moreover, similar results were found by Saran et al. [3] However, Gasteiger et al. [4], who compared size 2 LMA ProSeal versus I-Gel in nonparalyzed ventilated children, found that fiberoptic locations of the airway tube for the LMA ProSeal and the I-Gel were similar, with the vocal cords visible from the distal airway tube in 94 and 96%, respectively. Although several studies have surveyed the fiberoptic view in airway devices of various sizes in children, none of them have shown age-related differences in the fiberoptic view [15].

In our study, we found the I-Gel was stained with blood in 2/20 of patients (about 10%), 30% of cases of PLMA, and 25% of cases of CLMA. This agrees with Uppal et al. [19] who found that the incidence of visible blood on the I-Gel after removal was 12% (3/25). On the contrary, Richez et al. [20] found in their study on 71 women that no blood staining was noted after removal of the I-Gel device. Moreover, David et al. [17] reported only one case of visible blood staining on the removal of the I-Gel.

In our study, we found that 40% of patients experienced dysphagia after PLMA removal and 20% had dysphonia. With the cLMA, 15% of the patients experienced dysphonia and 60% of the patients had dysphagia, and with the I-Gel, 5% had dysphonia and 5% of patients had dysphagia. In contrast to our study, Brimacombe et al. [21] found no difference between the PLMA and the LMA in directly measured mucosal pressures, so postoperative sore throat may be similar between the two devices. Moreover, Evans et al. [22] studied the PLMA in 300 patients and found that approximately 20% of the patients had a mild sore throat. Similar results were found by Das et al. [5].

In conclusion, the study showed that I-Gel was easier to insert and took less time to insert than the PLMA. The study showed that the fiberoptic view was better with the I-Gel than the PLMA and cLMA. There were no differences among the I-Gel, cLMA, and PLMA regarding oropharyngeal leak pressure. Fewer complications were found with the I-Gel than the PLMA and cLMA.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

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AAGBI Pediatric Airway Guidelines. Available at: http://wwaagpiorguk/publications/apa-guidelines 10/12/2016.  Back to cited text no. 1
    
2.
Shimbori H, Ono K, Miwa T, Morimura N, Noguchi M, Hiroki K. Comparison of the LMA-ProSeal and LMA-classic in children. BJA 2004; 93:528–531.  Back to cited text no. 2
    
3.
Saran S, Mishra SK, Badhe AS, Vasudevan A, Elakkumanan LB, Mishra G. Comparison of i-gel supraglottic airway and LMA-ProSeal™ in pediatric patients under controlled ventilation. J Anaesthesiol Clin Pharmacol 2014; 30:195–198.  Back to cited text no. 3
[PUBMED]  [Full text]  
4.
Gasteiger L, Brimacombe J, Oswald E et al. LMA ProSeal vs. i-Gel in ventilated children: a randomised, crossover study using the size 2 mask. Acta Anaesthesiol Scand 2012; 56:1321–1324.  Back to cited text no. 4
    
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Das B, Mitra S, Jamil SN, Varshney RK. Comparison of three supra-glottic devices in anesthetised paralyzed children undergoing elective surgery. Saudi J Anaesth 2012; 6:224–228.  Back to cited text no. 5
    
6.
Lee J-H, Cho H-S, Shin W-J, Yang H-S. A comparison of supraglottic airway i-gelTM vs. classic laryngeal mask airway in small children. Korean J Anesthesiol 2014; 66:127–130.  Back to cited text no. 6
    
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Lee JR, Kim MS, Kim JT et al. A randomised trial comparing the i-gel with the LMA Classic in children. Anaesthesia 2012; 67:606–611.  Back to cited text no. 7
    
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Fukuhara A, Okutani R, Oda Y. A randomized comparison of the i-gel and the ProSeal laryngeal mask airway in pediatric patients: performance and fiberoptic findings. J Anesth 2013; 27:1–6.  Back to cited text no. 8
    
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Mitra S, Das B, Jamil SN. Comparison of size 2.5 i-gel with Proseal LMA in anaesthetised, paralyzed children undergoing elective surgery. N Am J Med Sci 2012; 4:453–457.  Back to cited text no. 9
    
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Goyal R, Shukla RN, Kumar G. Comparison of size 2 i-gel supra-glottic airway with LMA-ProSeal and LMA-Classic in spontaneously breathing children undergoing elective surgery. Paediatr Anaesth 2012; 22:355–359.  Back to cited text no. 10
    
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Walker RW. Paediatric airway. In: Calder I, Pearce A, editors. Core topics in airway management. Cambridge, UK; 2005. 1–8  Back to cited text no. 11
    
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Levitan RM, Kinkle WC. Initial anatomic investigations of the I-GEL airway: a novel supraglottic airway without inflatable cuff. Anaesth 2005; 60:1022–1026.  Back to cited text no. 13
    
14.
Dwivedi Y, Gupta A, Srivastava U, Jagar KD et al. Comparison of i-gel™, LMA Proseal™ and LMA Classic™ in spontaneously breathing pediatric patients. J Anesthesiol Clin Pharmacol 2016; 30:195–198.  Back to cited text no. 14
    
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Theiler LG, Kleine-Brueggney M et al. Performance of the pediatric-sized I-gel compared with the Ambu Aura Once laryngeal mask in anesthetized and ventilated children. Anesthesiology 2011; 115:102–110.  Back to cited text no. 15
    
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21.
Brimacombe J, Keller C, Fullekrug B et al. Multicenter study comparing the ProSeal and classic laryngeal mask airway in anesthetized, nonparalyzed patients. Anesthesiology 2002; 96:289–295.  Back to cited text no. 21
    
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