|Year : 2009 | Volume
| Issue : 3 | Page : 302-305
Comparison of Clinical Performance of I-GelTM with LMA-ProsealTM in Elective Surgeries
Ishwar Singh1, Monika Gupta2, Mansi Tandon3
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 Publication||3-Mar-2010|
70 Loknayak Apartments, Sector 9. Rohini, New Delhi
Source of Support: None, Conflict of Interest: None
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|| |
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|| |
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|| |
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|| |
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 , . Keller C,et al  and Lopez -Gil et al  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  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 , 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  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|| |
|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. |
|2.||Brain Al, Verghese C, Strube PJ. The LMA 'ProSeal'-a laryngeal mask with an oesophageal vent. Br J Anaesth 2000;84: 650-4. |
|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. |
|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. |
|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. |
|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. |
|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. |
[Table 1], [Table 2], [Table 3]