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CLINICAL INVESTIGATION
Year : 2009  |  Volume : 53  |  Issue : 3  |  Page : 302-305 Table of Contents     

Comparison of Clinical Performance of I-GelTM with LMA-ProsealTM in Elective Surgeries


1 Chairperson,Department of Anesthesiology. Jaipur Golden Hospital, New Delhi, India
2 Consultant, Department of Anesthesiology. Jaipur Golden Hospital, New Delhi, India
3 P.G.Student, Department of Anesthesiology. Jaipur Golden Hospital, New Delhi, India

Date of Web Publication3-Mar-2010

Correspondence Address:
Monika Gupta
70 Loknayak Apartments, Sector 9. Rohini, New Delhi
India
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Source of Support: None, Conflict of Interest: None


PMID: 20640137

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Sixty ASA grade I& II adult patients of either sex were randomly assigned into two groups .Group I (n=30) for I-gel and Group P (n=30) I'or LMA - ProSeal . We assessed the airway sealing pressure, ease of insertion, success rate of insertion, ease of gastric tube placement, airway trauma by post operative blood staining ofthe device, tongue, lip and dental trauma, hoarseness, regurgitation / aspiration and cost effectiveness. Although the airway sealing pressure was higher with Group P (29.6 cm H 2 O) than with Group I (25.27 cm H 2 0) (p < 0.05), but the airway sealing pressure of Group I was very well within the normal limit to prevent aspiration.The ease of insertion was more with Group I (29/30) than with Group P (25/30) (p <0.05). The success rate of first attempt of insertion and ease of gastric tube placement was more with Group I (p> 0.05). Blood staining of the device& tongue, lip and dental trauma was more with Group P (p >0.05). There was no evidence of bronchospasm, laryngospasm, regurgitation, aspiration or hoarseness in either group.
To conclude I-gel is a novel supraglottic device with an acceptable airway sealing pressure (25.27 cm H 2 O). It is easier to insert, requires less attempts of insertion, has easier gastric tube placement and is less traumatic as compared to LMA-ProSeal.

Keywords: I-gel, LMA - ProSeal, Airway sealing pressure


How to cite this article:
Singh I, Gupta M, Tandon M. Comparison of Clinical Performance of I-GelTM with LMA-ProsealTM in Elective Surgeries. Indian J Anaesth 2009;53:302-5

How to cite this URL:
Singh I, Gupta M, Tandon M. Comparison of Clinical Performance of I-GelTM with LMA-ProsealTM in Elective Surgeries. Indian J Anaesth [serial online] 2009 [cited 2020 Mar 30];53:302-5. Available from: http://www.ijaweb.org/text.asp?2009/53/3/302/60293


   Introduction Top


To overcome the limitations of currently available su­praglottic airway devices like LMA-ProSeal (eg. high cost, demand for careful handling to prevent cuff damage and relative difficulty of insertion) anew and cheaper supraglot­tic airway device "I-gel"(Intetsurgical Ltd., Wokingham, Berkshire, UK) has been developed [Figure 1]. I-gel is made up ofinedical grade thermoplastic elastomer, which is soft, gel like, transparent and designed to anatomically fit the peri laryngeal and hypopharyyngeaI structures with­out an inflatable cuff. It also has a port for gastric tube placement. I-gel is said to have easier insertion, mini­mal risk ol'tissue compression and stability alter inser­tion. It is a latex free supraglottic device. The buccal cavity stabilizer has a widened, elliptical, symmetrical and laterally flattened cross sectional shape ,providing good vertical stability upon insertion which is an ad­vantage over LMA with inflatable cuffs where mechani­cal inflation can cause movement ofthe device because the distal wedge shape of the mask is forced out ol'the upper oesophagus. The firmness ol'the tube section and its natural oropharyngeal curvature allows the de­vice to be inserted by grasping the proximal end of I­- gel and helps to glide the leading edge against the hard palate into the pharynx. It is not necessary to insert fingers into the mouth ofthe patient for full insertion. We compared I-gel and LMA - ProSeal in adults for the airway sealing pressure, ease of insertion, insertion attempts, ease of gastric tube placement, blood stain­ing ofthe device, tongue, lip& dental trauma, bron­chospasm /laryngospasm , regurgitation / aspiration and hoarseness .


   Methods Top


The present study was conducted in the Depart­ment of Anaesthesiology, Jaipur Golden Hospital, 2 in­stitutional area, New Delhi after obtaining ethics com­mittee clearance and written inlbrmed consent. Sixty ASA grade I and I I adult patients ofeither sex sched­uled for elective hernioplasty, laparoscopic cholecys­tectomy, tibial plating, humerus plating and skin graft­ing were selected. Patients with known difficult airway, cervical spine disease, mouth opening <2.5 cm, full stomach, hiatus hernia or gastroesophageal reflux dis­ease& emergency surgeries were excluded from the study.

All the patients received injection midazolam 1mg, glycopyrrolate 0.2mg, ranitidine 50 mg and metoclopramide 10 mg intravenously 45 minutes be­fore surgery. Anaesthesia was induced with propolol 2-2.5 ma.kg -1 and fentany 11-1.5µg.kg -1 .Neuromus­cular blockade was achieved with rocuronium 0.9 mg kg -1 . Both I-gel and LMA - ProSeal were lubri­cated with water soluble jelly. Once adequate depth was achieved each device was inserted by an experi­enced anaesthesiologist. Both the devices were fixed by taping the tube over the chin and lubricated gastric tube was placed into the stomach through the gastric channel. Maintenance was achieved by oxygen, nitrous oxide, isoflurane and intermittent doses of intravenous vecuronium. Intraoperative heart rate, noninvasive blood pressure, oxygen saturation and end tidal car­bon dioxide were recorded before induction and at 1 and 5 minutes after insertion ofdevice and then at ev­ery 5 minutes interval till the end of surgery.

An effective airway was judged by a square wave capnograph trace, normal thoraco - abdominal move­ment and absence ofleak. I fan effective airway could not be achieved the device was removed and three at­tempts were permitted before failure of insertion was recorded. Ifthree attempts were unsuccessful either an alternative device was inserted or the trachea was intu­bated. The number ofinsertion attempts was recorded.

The ease of insertion ofdevice was also recorded. Ease was defined as no resistance to insertion in the pharynx in a single maneuver. In a difficult insertion there was resistance to insertion or more than one maneuver was required for the correct placement of the device.

The ease of placement ofgastric tube was also re­corded and its correct placement was confirmed by in­jection of air and epi gastric auscultation or aspiration of gastric contents. Failure ofgastric tube placement was also recorded and it was defined as failure to advance the gastric tube into the stomach with in two attempts.

The airway sealing pressure was determined by closing the expiratory valve of the circle system at a fixed gas flow of 3 L/minute and recording the airway pressure (Cuffinflator / pressure gauge from Portex Germany) at which equilibrium was achieved .At this time gas leakage was determined at the mouth by the audible leak or by detection of an audible noise using a stethoscope placed just lateral to thyroid cartilage. At the end ofsurgical procedure anaesthesia was discon­tinued, patient was reversed with standard dose ofneo­stiamine and glycopyrrolate and the device was re­moved. Blood staining ofthe device and tongue, lip and dental trauma were recorded. Regurgitation of gas­tric contents was also assessed. Pharynaolaryngeal morbidit y was assessed as hoarseness of voice in the post-anaesthesia care unit and 24 hours subsequently.

The sample size was based on a crossover pilot study of 10 patients and was selected to detect a pro­jected difference of 30% between the groups for air­way sealing pressure for type I error of 0.05 and a power of0.8. Statistical analysis for airway sealing pressure was done by Fisher's t-test. For the two vari­ables, ease of insertion of gastric tube& bronchospasm lai yngospasm dichotomous nominal scale data corre­lation was applied. For the remaining characteristics Chi square test with Yate's correction was applied. Sig­nificance was taken as p < 0.05.


   Results Top


There was no difference between the two groups with respect to demographic and surgical details. [Table 1] In all patients the supraglottic device, L-gel or LMA -ProSeal, was inserted within three attempts. The av­erage airway sealing pressure with I-gel was 25.27 cm H2O and that with LMA - ProSeal was 29.6 cm H2O which was statistically significant (p<0.05) [Table 2]. The ease of' insertion was more with 1-gel (29/30) than with LMA - ProSeal (23/30) which was statistically significant (p<0.05) [Table 2]. The success rate at first attempt of insertion were 30/30 (100%) for I-gel& 28/30 (93.3%) for LMA -ProSeal which was statisti­cally not significant. [Table 2].The ease of insertion of gastric tube was more with I-gel (30/30) than with LMA - ProSeal (26/30) [Table 3]. Tongue , lip& dental trauma was more with LMA - ProSeal (5/30) than with I-gel (1/30) and blood staining ol'the device was more with LMA- ProSeal (6/30) than with I-gel (1/30) but the results were not statistically significant [Table 3]. There was no incidence of bronchospasm / laryn­gospasm, aspiration / regurgitation and hoarseness in both the groups. [Table 3]


   Discussion Top


We found, I-gel to be as effective as I,MA­ProSeal in providing patent airway during controlled ventilation of lungs. The airway sealing pressure was higher with LMA - ProSeal (29.6 cm H 2O) than with I-gel (25.27 cm H 2 O) a statistically significant finding butthe airway sealing pressure of'I-gel was also within normal limit and effective in preventing aspiration. In our study the sealing pressure was measured by clos­ing the expiratory valve of the circle system at a fixed fresh gas flow of 3 L /minute until airway pressure reached a steady value [2],[3] . Keller C,et al [4] and Lopez -Gil et al [5] compared four kinds of measurements of the airway sealing, pressure, which involved detection of audible noise by listening over the mouth, detection of exhaled carbon dioxide by placing a gas sampling line for the capnograph inside the mouth , detection °la steady value airway pressure while occluding the expi­ratory, valve of the circle system and detection ofan audible noise using a stethoscope placed just lateral to the thyroid cartilage. They concluded that all four tests were excellent.

The ease of insertion was more with I-gel (29/ 30) than with LMA - ProSeal (23/30) which was a statistically significant di fference. Levitan& Kinkle [1] presumed that on insertion oil ,MA with inflatable mask the deflated leading edge ofthe mask can catch the edge ofthe epiglottis& cause it to doNA nfold or impede proper placement beneath the tongue. Brimacombe and colleagues [6],[7] presumed that the difficulties in inserting LMA - ProSeal were caused by larger cuff impeding digital intra - oral positioning and propulsion into the pharynx, the lack ofa backp late making cuffmore likely to fold over at the back of mouth and the need for more precise tip positioning to prevent air leaks up the drainage tube.

Incidence of blood staining ofthe device was more with LMA - ProSeal (6/30) than with I-gel ( 1 /30)& tongue, lip& dental trauma was more with LMA­ProSeal (5/30) than with I-gel ( 1 /30) which was otherwise statistically not significant. Levitan& Kinkle [1] pre­sumed that inflatable masks have the potential to cause tissue distortion, venous compression& nerve injury. The ease of aastric tube placement was more with I-gel (30/30) than with LMA - ProSeal (26/30), though the difference was not statistically significant. Also there was no statistical difference between the insertion at­tempts ofthe devices. Both I-gel and LMA - ProSealhad no incidence of bronchospasm / laryngospasm, aspiration / regurgitation and hoarseness.

To conclude the I-gel is a cheap and effective device which is easier to insert (statistically significant as compared to LMA - ProSeal). It has other poten­tial advantages like effective airway sealing pressure which was within the normal limit, easier gastric tube placement, less blood staining of the device and less tongue, lip and dental trauma.

In our opinion the I -gel is a useful supraglottic device.



 
   References Top

1.Levitan R M and Kinkle W C. Initial anatomic investi­gations of the 1-gel airway : a novel supraglottic airway without inflatable cuff. Anaesthesia 2005;60:1022-1026.  Back to cited text no. 1      
2.Brain Al, Verghese C, Strube PJ. The LMA 'ProSeal'-a laryngeal mask with an oesophageal vent. Br J Anaesth 2000;84: 650-4.  Back to cited text no. 2      
3.Shimbori H, Ono K , Miwa T , Morimura N, Noguchi M ,H iroki K. Comparison of the LMA ProSeal and LMA classic in children. Br J Anaesth 2004;93:528 -31.  Back to cited text no. 3      
4.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.  Back to cited text no. 4      
5.Lopez-Gil M, Brimacombe J, Keller C. A comparison of four methods for assessing oropharyngeal leak pres­sure with the laryngeal mask airway (LMA) in paediat­ric patients. Paediatr Anaesth 2001; 1 1 : 319-21.  Back to cited text no. 5      
6.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.  Back to cited text no. 6      
7.Brimacombe J. Keller C, Fullekrug B, et al. A mu lticenter study comparing the ProSeal and Classic laryngeal mask airway in anesthetized, nonparalyzed patients. Anes­thesiology 2002; 96:289-95.  Back to cited text no. 7      


    Figures

  [Figure 1]
 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

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