Table of Contents  
ORIGINAL ARTICLE
Year : 2015  |  Volume : 8  |  Issue : 3  |  Page : 330-333  

Evaluation of the I-gel, a supraglottic airway device in children undergoing day care surgery


Department of Anaesthesia, Seth G S Medical College and K E M Hospital, Mumbai, Maharashtra, India

Date of Web Publication15-May-2015

Correspondence Address:
Sushma Raghunath Tandale
45/1792, Apna Ghar Housing Society, Vartak Nagar, Thane (West), Mumbai - 400 606, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0975-2870.157078

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  Abstract 

Background: The i-gel is a novel supraglottic airway device, made up of medical grade thermoplastic elastomer. Its soft noninflatable cuff causes easier insertion, minimal tissue compression and stability after insertion. An integral gastric channel is provided for passage of gastric drainage tube to empty the stomach. Materials and Methods: We evaluated i-gel in sizes ranging from 1.5 to 2.5 in pediatric patients considered suitable for a supraglottic device. We assessed ease of insertion, insertion time, ease of insertion of gastric drain tube, adequacy of ventilation, oropharyngeal leak pressure and complications with the use of the device. Results: We studied the use of the i-gel in 120 anaesthetized children with a mean age 5.2 years and weight 16.96 kg to assess its safety and efficacy. First insertion attempt was successful in 94.11% of patients. The mean time to insertion was 9.5 s. Ease of insertion score of i-gel airway device was Grade I/Grade II/Grade III in 90.83%/8.33%/0.83% patients respectively. Ease of insertion score for gastric drainage tube through device was Grade I/Grade II in 99.16%/0.83% of patients. Mean oropharyngeal leak pressure was 20 cm of H 2 O. Intraoperatively six patients required manipulation to improve the airway and two patients had minor complications in the postoperative period. Analysis of the difference among the three sizes of i-gel was performed using the Chi-square test, fisher's exact test and one-way ANOVA test. Statistical analysis revealed no significant difference in a number of insertion attempts, ease of insertion score for i-gel and gastric drainage tube, insertion time, intraoperative and postoperative complications among the various sizes of i-gel. Conclusion: The i-gel was inserted without complications, establishing a clear airway and enabling spontaneous and controlled ventilation in majority of patients. This device is easy to use and has low pharyngolaryngeal morbidity.

Keywords: I-gel, paediatric patients, supraglottic airway


How to cite this article:
Tandale SR, Dave NM, Garasia M. Evaluation of the I-gel, a supraglottic airway device in children undergoing day care surgery. Med J DY Patil Univ 2015;8:330-3

How to cite this URL:
Tandale SR, Dave NM, Garasia M. Evaluation of the I-gel, a supraglottic airway device in children undergoing day care surgery. Med J DY Patil Univ [serial online] 2015 [cited 2024 Mar 29];8:330-3. Available from: https://journals.lww.com/mjdy/pages/default.aspx/text.asp?2015/8/3/330/157078


  Introduction Top


The i-gel is a supraglottic airway device which is made up of thermoplastic elastomer. It is latex free, gel like, transparent and provides noninflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures. [1] An integral gastric channel is provided for suction of gastric contents.

I-gel in adults has provided satisfactory airway with easy insertion. [2],[3] Subsequently, other papers confirmed the efficacy of the device in pediatric population. We aimed to study the efficacy and safety of the device in the Indian pediatric population, in a large cohort study. The study was carried out in a university teaching hospital attached to a tertiary care referral center. We performed an observational study in 120 anesthetized children to evaluate safety and efficacy of i-gel. Our primary aim was to determine ease of insertion of i-gel airway and gastric drain tube through i-gel and assess the adequacy of ventilation. We also studied the time to insertion, oropharyngeal leak pressure and complications following i-gel insertion.


  Materials and Methods Top


This observational study was conducted after approval from hospital Ethics Committee and Departmental Permission. Children of age between 1 and 12 years, undergoing elective procedures such as herniotomy, orchiopexy, hypospadias repair, circumcision, rectal polyp removal were included in the study over a period of 6 months. Patients with anticipated difficult airway, oropharyngeal pathology, inadequate starvation and gastroesophageal reflux were excluded. Informed and written consent was obtained from parents.

All patients were premedicated with midazolam 0.05 mg/kg intravenously. Anesthesia was induced with intravenous fentanyl 1-2 mcg/kg and propofol 3 mg/kg with or without atracurium 0.5 mg/kg. Muscle relaxants were used as per the need of surgical procedure and discretion of the senior anesthetist. Lubricated i-gel of appropriate size was inserted into the oral cavity, directed posteriorly against the hard palate and advanced with gentle pressure until the resistance was felt. Manipulations such as jaw thrust or slight twisting of device in the oropharynx were performed as required to aid insertion. Standard monitoring for all patients included electrocardiogram, pulse oximetry, capnometry and noninvasive blood pressure measurement.

Correct placement of the device was assessed by visible chest expansion, absence of audible leak during ventilation and square shaped capnograph. After fixation of the device, lubricated gastric tube of appropriate size was inserted through gastric channel in all patients. Oropharyngeal leak pressure was determined by closing the expiratory valve of the circle system at a fixed gas flow of 3 L/min and recording the airway pressure at which equilibrium was achieved. At this time gas leakage was determined at mouth by audible leak and/or by detection of an audible noise by using stethoscope placed just lateral to thyroid cartilage.

In case of failure to achieve adequate ventilation with two attempts of i-gel airway, alternative supraglottic airway or endotracheal tube of appropriate size was used and it was considered as a failure of i-gel airway.

Anesthesia was maintained with O 2 and air (50:50) and Sevoflurane using circle absorber with spontaneous and if required, assisted ventilation. All patients who needed muscle relaxants were ventilated with volume controlled ventilation with tidal volume of 6-8 ml/kg to maintain end-tidal carbon dioxide between 30 and 40 mmHg. At the end of surgery stomach was aspirated with the help of the gastric tube and neuromuscular block was reversed in patients who received muscle relaxant. Clinical judgment was used to determine the best time for device removal after appearance of airway reflexes.

During the insertion of i-gel, we recorded the number of insertion attempts, insertion time, ease of insertion of i-gel and gastric drainage tube through i-gel. Insertion time of i-gel was time between pick up of device and establishment of adequate ventilation.

Ease of device insertion was recorded as

  1. Very easy: No resistance to insertion in the pharynx in a single maneuver.
  2. Easy: When insertion into the pharynx required maneuver like jaw thrust.
  3. Difficult: When more than two manoeuvres were needed like device rotation, jaw thrust.


The ease of placement of gastric drainage tube was recorded as

  1. Easy: Passage of gastric drainage tube without resistance and confirmed by auscultation over epigastrium.
  2. Difficult: Resistance to placement of gastric drainage tube requiring manipulation of i-gel.


Intraoperative complications such as manipulations required maintaining airway, displacement of device, leak during ventilation, laryngospasm/bronchospasm, coughing and limb movement during insertion and postoperative complications like blood on device, change in voice, sore throat were noted.

Analysis of the difference among the three sizes of i-gel was performed using the Chi-squared test, Fisher's exact test and one-way ANOVA test. P < 0.05 was considered as statistically significant.


  Results Top


We studied 113 male and 7 female patients of age between 1 and 12 years, (mean age 5.2 years) and weight between 8 and 33 kg (mean weight 16.96 kg). I-gel sizes 1.5, 2, 2.5 were used according to manufacturer's recommendations [Table 1]. 56 (46.66%) and 64 (53.33%) of patients were maintained on spontaneous ventilation and controlled ventilation respectively. Mean procedure time was 48 min.
Table 1: Number of patients and recommended i-gel airway device size as per manufacturer's instruction

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Insertion and adequate ventilation were possible in 119 out of 120 patients. One patient had failed insertion and required alternative airway device from beginning of surgery. Insertion was successful in first attempt in 94.11% (113 out of 119) patients, second attempt in 5.88% (6 out of 119) patients overall [Table 2].
Table 2: Size of i-gel and insertion attempts

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I-gel was very easy to insert in 84.84%/92.75%/94.44% patients with size1.5/2/2.5 respectively and easy to insert in 12.12%/7.24%/5.55% with size 1.5/2/2.5 respectively. Insertion was difficult in 3.03% patients with size 1.5. Statistical analysis revealed no significant difference between ease of insertion of i-gel amongst sizes 1.5, 2 and 2.5 (P = 0.45).

Gastric drainage tube insertion was easy in 96.96% patients with size 1.5, 100% with sizes 2 and 2.5. 3.03% patients had difficult gastric tube insertion with size 1.5 [Table 3]. Statistical analysis revealed no significant difference between ease of insertion of gastric drainage tube through i-gel amongst sizes 1.5, 2 and 2.5 (P = 0.42).
Table 3: Ease of insertion score for i-gel airway and gastric drainage tube

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Mean insertion time for all sizes of i-gel was 9.5 s and 9.84/9.33/9.33 s for sizes 1.5/2/2.5 respectively. Statistical analysis revealed no significant difference between mean insertion times for i-gel of sizes 1.5, 2 and 2.5 (P = 0.49).

The oropharyngeal leak pressure with the i-gel was 20 cm of H 2 O with the range between 16 and 26 cm of H 2 O.

Six patients required intraoperative manipulation to maintain a satisfactory airway. Four of them required reinsertion of same i-gel due to displacement, one required jaw thrust and one required neck extension. Two patients had complaints of sore throat and changed in voice postoperatively. No patient had limb movement during i-gel insertion, or laryngospasm, coughing perioperatively. Statistical analysis revealed no significant difference for intraoperative complications (P = 0.07) and postoperative complications (P = 0.42) amongst the various sizes of i-gel.


  Discussion Top


New supraglottic airway devices continue to be invented and marketed. It becomes imperative, then, that these devices are evaluated thoroughly in the local context. Our aim was to evaluate the safety and efficacy of the i-gel in children across a wide spectrum of age and size. Our results demonstrate that the i-gel was an effective airway device in this cohort of 120 children. Only one patient had failure of ventilation and required alternative airway device. Other studies also confirm the ease of insertion and successful maintenance of airway using i-gel in patients ranging from infants to adolescents. [4],[5],[6]

Mean insertion time in our study was 9.5 s. Insertion times ranging from 11 to 19 s have been reported in other studies. [4],[7],[8] The oropharyngeal leak pressure in other studies varied between 20 and 26 cm H 2 O. Our results are comparable. [4],[5],[6],[7]

Complications in several studies ranged between 11% and 20% and it included coughing, displacement, laryngospasm, desaturation, stridor, change in airway device, intraoperative manipulations to improve airway, blood on device, postoperative sore throat and change in voice. [4],[5],[7] In our study, complications were minor and infrequent. We believe some of the complications listed in the above mentioned studies could also have been a consequence of inadequate depth of anesthesia, amongst other factors, and not directly related to the device per se.

Beringer et al. studied the difference among the three sizes of i-gel viz, 1.5, 2, 2.5 and found no statistically significant difference in the number of insertion attempts, leak pressure or complications. [4] These results are similar to our study findings.

A literature search conducted to study the use of the device in Indian children revealed two results. [9],[10] Das et al. showed comparable results in terms of hemodynamic parameters, ease of insertion and postoperative complications amongst i-gel, proseal laryngeal mask airway (LMA) and classic LMA group, each group containing 30 pediatric patients of age between 1 and 6 years and also showed that airway seal pressure was high in i-gel group. [9] Saran et al. also concluded that i-gel is as effective as proseal LMA in terms of ease of insertion of device and gastric drainage tube through device, insertion attempts, adequacy of ventilation and fiberoptic view of glottis in 60 pediatric patients of age between 1 and 12 years. [10] These corroborate our findings regarding safety and effectiveness of the device. As paediatric fiberoptic was not available at our institute, we could not study the fiberoptic view of the glottis through i-gel.

The strength of our study is that we evaluated different sizes of i-gel across patients with differing ages and sizes, in a large study. That we did not do a randomized, controlled trial may be a limitation of our study. However, since the other supraglottic devices (classic, proseal LMA) have been studied extensively, we limited our study to testing the i-gel in a large sample of pediatric patients.


  Conclusion Top


I-gel airway can be used safely and effectively in anesthetized children with spontaneous and assisted ventilation. This device is easy to use and is associated with low pharyngolaryngeal morbidity.

 
  References Top

1.
Levitan RM, Kinkle WC. Initial anatomic investigations of the I-gel airway: A novel supraglottic airway without inflatable cuff. Anaesthesia 2005;60:1022-6.  Back to cited text no. 1
    
2.
Gatward JJ, Cook TM, Seller C, Handler J, Simpson T, Vanek V, et al. A cohort evaluation of the size 4 I-gel airway in one hundred non paralyzed patients. Anaesthesia 2008;63:1124-30.  Back to cited text no. 2
    
3.
Janakiraman C, Chethan DB, Wilkes AR, Stacey MR, Goodwin N. A randomised crossover trial comparing the i-gel supraglottic airway and classic laryngeal mask airway. Anaesthesia 2009;64:674-8.  Back to cited text no. 3
    
4.
Beringer RM, Kelly F, Cook TM, Nolan J, Hardy R, Simpson T, et al. A cohort evaluation of the paediatric i-gel (™) airway during anaesthesia in 120 children. Anaesthesia 2011;66:1121-6.  Back to cited text no. 4
    
5.
Theiler L, Gutzmann M, Kleine-Brueggeney M, Urwyler N, Kaempfen B, Greif R. i-gel™ supraglottic airway in clinical practice: A prospective observational multicentre study. Br J Anaesth 2012;109:990-5.  Back to cited text no. 5
    
6.
Abukawa Y, Hiroki K, Ozaki M. Initial experience of the I-gel supraglottic airway by the residents in pediatric patients. J Anesth 2012;26:357-61.  Back to cited text no. 6
    
7.
Hughes C, Place K, Berg S, Mason D. A clinical evaluation of the I-gel ™ supraglottic airway device in children. Paediatr Anaesth 2012;22:765-71.  Back to cited text no. 7
    
8.
Kannaujia A, Srivastava U, Saraswat N, Mishra A, Kumar A, Saxena S. A preliminary study of I-gel: A new supraglottic airway device. Indian J Anaesth 2009;53:52-6.  Back to cited text no. 8
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9.
Das B, Mitra S, Samanta A, Vijay BS. Comparision of i-gel supraglotic device with classic laryngeal mask airway in anaesthetized paralysed children undergoing elective surgery. Anesth Essays Res 2012;6:180-3.  Back to cited text no. 9
  Medknow Journal  
10.
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;30:195-8.  Back to cited text no. 10
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    Tables

  [Table 1], [Table 2], [Table 3]


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