|Year : 2017 | Volume
| Issue : 2 | Page : 47-53
Laryngeal mask airway versus i-gel for airway maintenance during general anesthesia with controlled ventilation in pediatrics
Maher E Ramadan, Doreyya M Fikry, Mohamed S Elhadidi, Huda A.Z. Boghdady
Department of Anaesthesia and Surgical Intensive Care, Faculty of Medicine, Alexandria University, Alexandria, Egypt
|Date of Submission||18-Apr-2016|
|Date of Acceptance||08-Mar-2017|
|Date of Web Publication||12-May-2017|
Huda A.Z. Boghdady
70 Ibn Monkez Street, Alexandria
Source of Support: None, Conflict of Interest: None
Supraglottic airway devices have become prevalent in children because they are typically more user-friendly than a face mask and avoid many of the problems associated with endotracheal intubation. i-gel is a new single-use supraglottic airway device without an inflatable cuff. Pediatric i-gel is now available in four different sizes, 1, 1.5, 2, and 2.5, on the basis of body weight.
Patients and methods
This study was carried out in Alexandria University Hospitals on 70 patients of American Society of Anesthesiologists grade I and II, aged 3–6 years. They were classified randomly into two equal groups of 35 patients each and admitted to undergo elective surgery under general anesthesia with controlled ventilation in the supine position without head and neck manipulation. In group I, a classic laryngeal mask was used and in group II, i-gel was used to maintain a patent airway during anesthesia. The devices were compared in terms of insertion success, hemodynamic responses, oropharyngeal sealing pressure, airway interventional requirements during maintenance, and postoperative complications.
The time of insertion of i-gel was significantly shorter than that of the classic laryngeal mask airway (cLMA) (P<0.001) and the airway sealing pressure for the i-gel was significantly higher than that for the cLMA (P=0.043).
Both the i-gel and the cLMA are suitable devices for controlled ventilation for pediatric patients undergoing short surgical procedures who are not at risk of aspiration. The insertion time of i-gel was less than that of cLMA and airway sealing pressure of i-gel was higher than that of cLMA.
Keywords: classic laryngeal mask airway, i-gel, pediatrics
|How to cite this article:|
Ramadan ME, Fikry DM, Elhadidi MS, Boghdady HA. Laryngeal mask airway versus i-gel for airway maintenance during general anesthesia with controlled ventilation in pediatrics. Res Opin Anesth Intensive Care 2017;4:47-53
|How to cite this URL:|
Ramadan ME, Fikry DM, Elhadidi MS, Boghdady HA. Laryngeal mask airway versus i-gel for airway maintenance during general anesthesia with controlled ventilation in pediatrics. Res Opin Anesth Intensive Care [serial online] 2017 [cited 2017 Dec 13];4:47-53. Available from: http://www.roaic.eg.net/text.asp?2017/4/2/47/206153
| Introduction|| |
Supraglottic airway device (SAD) is designed to maintain a clear airway while creating a seal around the larynx. It may be used in elective surgery as an airway rescue device in failed tracheal intubation, as a conduit for tracheal intubation, or in emergencies such as cardiorespiratory arrest, both in and out of hospital .
SADs have been used in pediatric anesthesia by Lopez-Gil et al.  to adequately secure the airway without any major intraoperative morbidity for spontaneous and controlled ventilation.
The i-gel has been commercially available in sizes suitable for children since 2010. It has a noninflatable cuff and an additional lumen (except in size 1) for active or passive drainage of gastric contents. It is available in four pediatric sizes (1, 1.5, 2, and 2.5) .
Laryngeal mask airway (LMA) has become a very important part of the airway management of adults and, now, children. Availability of different sizes (1, 1.5, 2, and 2.5) together with favorable clinical experiences have led to the increasing use of LMA in children .
| Patients and methods|| |
After approval of the local ethical committee and obtaining an informed written consent from the parents of every patient, the present study was carried out in Alexandria University Hospitals on 70 patients of American Society of Anesthesiologists grade I and II, aged 3–6 years, and scheduled to undergo elective surgery under general anesthesia with controlled ventilation in the supine position without head and neck manipulation.
Patients who fulfilled the following criteria were excluded:
- Neuromuscular diseases.
- Pulmonary diseases (e.g. asthma).
- Patients with syndromes with anticipated difficult airway (e.g. Goldenhar syndrome, mucopolysacaridosis, etc.).
- Any condition with increased risk of regurgitation and aspiration of gastric contents.
- Prolonged surgeries (>1 h).
- Patients with pharyngeal pathology, for example, abscess and hematoma.
They were divided randomly into two equal groups of 35 patients each.
Group I: classic laryngeal mask was used to maintain a patent airway during anesthesia.
Group II: i-gel was used to maintain a patent airway during anesthesia.
All children were assessed preoperatively by a detailed assessment of history from their parents, a complete clinical examination, airway assessment, and routine laboratory investigations. Written informed consent was obtained from the parents before intervention. All children fasted 2 h for clear fluid and water, 6 h for solids.
EMLA cream was applied to the dorsum of both hands 1 h before surgery. All children were premedicated with chloral hydrate 25–50 mg/kg orally 30 min before induction of anesthesia.
On arrival to the operating room, children were connected to the standard monitoring including ECG, noninvasive arterial blood pressure, and a pulse oximeter. For all children, an intravenous access was established. After preoxygenation with 100% oxygen for 3 min, induction of anesthesia was carried out by administration of fentanyl 1 μg/kg, followed by propofol 3 mg/kg intravenously (10 mg lignocaine 1% was added to each 100 mg propofol). Atracurium of 0.5 mg/kg was administered. Ventilation was provided through a face mask with 100% O2 and 1.2% isoflurane for 2–3 min once an adequate depth of anesthesia was achieved (no eye lash reflex and no response to jaw thrust). The airway devices were inserted according to the manufacturer’s recommendations. Then, the children were mechanically ventilated; the ventilator was adjusted to administer 8–10 ml/kg body weight and patient’s respiratory rate was controlled to maintain EtCO2 between 30 and 35 mmHg with an I : E ratio of 1 : 2. Anesthesia was maintained by isoflurane 1.2% in 100% oxygen. At the end of surgery, anesthesia was shut off, the muscle relaxant was reversed, with neostigmine 0.04 mg/kg and atropine 0.02 mg/kg, and the device was removed after the children regained consciousness and breathed spontaneously.
The following parameters were measured:
- Insertion criteria:
- Time to successful insertion of the airway device.
From the insertion of the device in the mouth to the establishment of effective ventilation (no audible leak, symmetrical movement of the chest wall, and square wave capnograph trace).
- Number of attempts to successful insertion: After three failed attempts, device insertion was recorded as a failure and an endotracheal tube (ETT) was used.
- Airway sealing pressure:
Fresh gas was insufflated at 3 l/min, the spill valve was occluded, and the minimum airway pressure at which gas could have been heard leaking around the airway device was measured. Peak airway pressure was not allowed to exceed 40 cmH2O.
- Maintenance success: Adequacy of ventilation was assessed by expiratory tidal volume (ml) and peak airway pressure (cmH2O). They were recorded every 15 min of ventilation with the device.
- Airway interventional requirements during maintenance were as follows:
Adjust head and neck position, jaw thrust, reinsertion, or changing the device.
- Hemodynamic measurements:
- Pulse (beats/min).
- Mean arterial blood pressure (mmHg).
- Arterial oxygen saturation (%).
These hemodynamic parameters were measured continuously and recorded at the following times:
- Before the induction of anesthesia.
- After the induction of anesthesia and before insertion of the airway device.
- Just after the insertion of the airway device.
- Five minutes after the insertion of the airway device.
- Ten minutes after the insertion of the airway device.
- After removal, the device was inspected for traces of blood.
- Laryngeal spasm.
- Hoarse cry.
- Sore throat.
Data were described using range, percentage (%), arithmetic mean, and SD. Analysis was carried out using the following tests of significance: independent t-test for two independent groups, paired t-test for paired samples, χ2 and Fisher’s exact tests for qualitative data, as well as the Z-test for differences in two proportions. The P value was considered statistically significant if less than 0.05.
| Results|| |
In terms of demographic data (sex, weight, and age), there were no statistically significant differences between the groups studied (P=0.631, 0.356, and 0.821).
In terms of the duration of the operation, there was no statistically significant difference between the two groups (P=0.580).
In terms of time of successful insertion, for group I (LMA), it ranged from 14 to 31 s, with a mean of 18.83±3.73, whereas for group II i-gel, it ranged from 11 to 25 s, with a mean of 15.31±3.07. There was a statistically significantly higher mean in group I (LMA) compared with the mean in group II (i-gel) (P<0.001) ([Figure 1]).
|Figure 1 Comparison between the two groups studied according to the time (s) of successful insertion. LMA, laryngeal mask airway|
Click here to view
There was no statistically significant difference between the two groups in the number of successful insertion attempts (P=0.167).
Airway sealing pressure (cmH2O) at the time of insertion for group I [classic laryngeal mask airway (cLMA)] ranged from 18 to 23 cmH2O, with a mean of 19.89±1.75, whereas for group II (i-gel), it ranged from 17 to 27 cmH2O, with a mean of 21.06±2.85. There was a statistically significantly higher mean of group II (i-gel) compared with the mean of group I (LMA) (P=0.043) ([Figure 2]).
|Figure 2 Comparison between the two groups studied according to airway sealing pressure (cmH2O) at the time of insertion. LMA, laryngeal mask airway|
Click here to view
Expiratory tidal volume (ml) and peak airway pressure (cmH2O), which were measured every 15 min throughout the operation, showed no statistically significant differences between the two groups.
Some cases in both groups required airway manipulations to achieve a good placement of the airway devices and hence the establishment of a successful ventilation. For group I (LMA), three (8.6%) patients required adjustment by head and neck flexion and extension, two (5.7%) patients required jaw thrust, and four (11.4%) patients required reinsertion, whereas in group II (i-gel), one (2.9%) patient required jaw thrust and another one (2.9%) required reinsertion. For both groups, there were no need to change the airway device by ETT. There were no statistically significant differences between the two groups studied (P=0.05) ([Table 1]).
|Table 1 Comparison between the two groups studied according to airway interventional requirements|
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On comparing between the two groups, there were no significant differences in the hemodynamic response just before induction of anesthesia, before insertion, just after insertion, and 5 or 10 min after insertion of the devices.
In terms of the complications encountered during this comparative study, for group I (LMA), there were traces of blood on the device after its removal in four (12.5%) cases, two (6.3%) cases developed laryngeal spasm, and one (3.1%) patient developed sore throat, whereas in group II (i-gel), one (2.9%) patient had blood traces on i-gel after removal and one (2.9%) patient developed laryngeal spasm; none of the patients had sore throat or hoarse cry ([Table 2]).
|Table 2 Comparison between the two groups studied according to complications|
Click here to view
| Discussion|| |
In terms of the insertion of both devices, the i-gel group had a significantly shorter time of insertion than cLMA as the time of insertion of i-gel was 15.31±3.07 s and that for cLMA was 18.83±3.73 s.
The different key components of the i-gel worked together to provide easy and short duration of i-gel insertion and high stability after insertion. It has a noninflatable cuff; thus, there is no change in position with cuff inflation as occurs with other SAD with inflatable cuffs .
Our results are in agreement with the study by Lee et al. , in which it was found that i-gel could be inserted faster than the cLMA (median 17 vs. 21 s, respectively; P=0.002). Also, Tokgoz et al.  found that the i-gel could be inserted faster than the LMA ProSeal (mean 19 vs. 28 s, respectively; P=0.01).
However, Kus et al.  reported that a longer time for insertion was required for the i-gel than the LMA Supreme (mean 13 vs. 11 s, respectively; P=0.001). In another trial conducted by Theiler et al. , it took a longer time for the i-gel to be inserted than the Ambu AuraOnce device (median 26 vs. 24 s, respectively; P=0.02); these times are longer than those in other studies because the time required for the fixation of the device was included, whereas in most of the other studies, the common definition of insertion time was the time from removal of the face mask (or picking up of the device) until confirmation of adequate ventilation (a ‘square wave’ end-tidal capnography trace and symmetrical chest wall movement).
Also, Abukawa et al.  found that a mean insertion time for the i-gel of 23 s. This may be because of the fact that in the study by Abukawa et al. , the i-gels were inserted by trainees rather than by experienced consultants.
In terms of the number of attempts at successful insertion, there was no significant difference between the two groups. The success rate of the first attempt of insertion for the i-gel was 97.14%, whereas for cLMA, it was 88.57%. In one patient, a second attempt was required for successful insertion in the i-gel group and in four cases in the LMA group (P=0.167).
The results of Lee et al.  were also nonsignificant in terms of the success rate for the i-gel at the first attempt (96%) and for cLMA (92%) (P=0.385). This study was carried out on 99 children aged from 1 to 108 months; in two children, a second attempt was required for insertion in the i-gel group and in four children, a second attempt was required for insertion in the cLMA group .
Our results are also in agreement with the study of Das et al.  that was carried out on 60 children aged from 1 to 6 years using i-gel size-2. He found that insertion of i-gel was successful in the first attempt in 28 of 30 patients and comparable with 27 of 30 in cLMA .
Beylacq et al.  also reported a successfully inserted i-gel at the first attempt in all of their pediatric patients (mean age: 12 years). Beringer et al.  carried out an i-gel study on 120 anesthetized children using different sizes (1.5, 2, and 2.5) (mean age: 5 years) and reported first attempt success rates of 85, 96, and 86%, respectively, and an overall success rate of 92% for the i-gel group.
Theiler et al.  compared the use of i-gel and the Ambu AuraOnce laryngeal mask device in children (mean age: 6 years) and reported first attempt and overall success rates of 93 and 98%, respectively.
In contrast, Lee et al. , whose study was carried out on 63 children aged from 4 to 72 months, found that the rates of successful insertion at the first attempt were 77 and 88% using i-gel and cLMA, respectively (P=0.54). The overall success rates using i-gel and cLMA were 87 and 100%, respectively. These results seem to be very low in comparison with other studies. Lee et al.  supposed that the low success rate could be because of the younger median age of patients and the higher percentage of 1.0-sized and 1.5-sized devices that were used compared with other studies. Lee et al. supposed that the overall success rate of 1.0-sized and 1.5-sized i-gel devices (79%) was lower than that of 2.0-sized and 2.5-sized i-gel devices (88%) .
The insertion success rate for the i-gel was high even when performed by nonanesthetists; Abukawa et al.  found a 94% initial success rate for nonanesthetists inserting various sized i-gels, whereas Schunk et al.  compared insertion success rates for 66 healthcare professionals during a simulated pediatric resuscitation and found that the i-gel was superior to both the LMA and the laryngeal tube.
The airway sealing pressure for i-gel was statistically significantly higher than that of cLMA: 21.06±2.85 for i-gel and 19.89±1.75 for cLMA.
This is because the i-gel is a truly anatomical device, achieving a mirrored impression of the pharyngeal, laryngeal, and perilaryngeal structures, without causing any compression, displacement, or trauma to tissues and structures in the vicinity; the soft noninflatable cuff fits snugly onto the perilaryngeal framework, thus supporting the seal by enveloping the laryngeal inlet. The thermoplastic properties of the gel cuff may form a more efficient seal around the larynx after warming to body temperature .
Five randomized trials, including 356 patients in total, compared the i-gel with the cLMA. The average oropharyngeal leak pressure ranged from 22 to 26 cmH2O and was significantly higher in the i-gel group than the cLMA group in two of the five studies.
Our results are in agreement with those of Das et al. , who found a significant difference in oropharyngeal leak pressure between cLMA and i-gel: 22.64±2.2 cmH2O for cLMA and 26.1±2.4 cmH2O for the i-gel.
Also, our results were further supported by the results of the study carried out by Goyal et al. , who found that an oropharyngeal leak pressure in the cLMA group of 22±2.3 cmH2O and that for the i-gel group of 26±2.63 cmH2O.
However, Lee et al.  used an i-gel 1.5–2.5 in size and found no significant difference in leak pressures between i-gel and cLMA (P=0.91). Also, Kim et al.  compared the i-gel with the cLMA in infants and found the i-gel easier to insert; otherwise, the characteristics of both devices were similar (P=0.117).
The i-gel was compared with the LMA ProSeal in six randomized trials that included a total of 473 patients. The largest trial was conducted by Tokgoz et al.  and included i-gel sizes of 1–2.5 in mechanically ventilated children. The authors did not separate results by i-gel size, but, overall, found a significantly higher leak pressure in the i-gel group, 28 cmH2O, and 20 cmH2O for LMA ProSeal  (P<0.01).
Mitra et al.  used only size-2.5 SADs in controlled ventilated children and found that a higher leak pressure 27 cmH2O for the i-gel versus 23 cmH2O for LMA ProSeal (P<0.0001).
Theiler et al.  compared the pediatric i-gel with the Ambu AuraOnce in 147 patients. The mean oropharyngeal leak pressure was significantly higher for the i-gel (20 vs. 18 cmH2O; P<0.01).
Hence, a pediatric i-gel can provide a safety margin in terms of airway leak pressure for ventilation of small children undergoing general anesthesia.
In terms of airway device intervention requirements during maintenance of anesthesia, some patients in both groups required airway manipulations to achieve a good placement of the airway devices and hence the establishment of a successful ventilation. In group I (cLMA), three patients required adjustment of the head, neck flexion, and extension (8.6%), two (5.7%) patients required jaw thrust, and four (11.4%) patients required reinsertion, whereas in group II (i-gel) one (2.9%) patient required jaw thrust and another one (2.9%) required reinsertion. In both groups, there was no need to change the airway device by ETT. There were no statistically significant differences between the two groups studied (P<0.05).
This is caused by artificial epiglottis in i-gel and protective ridge prevent the epiglottis from down-folding or obstructing the distal opening of the airway. The epiglottic ridge at the proximal end of the bowl rests at the base of the tongue, thus keeping the device from moving upwards out of position and the tip from moving out of the upper esophagus .
The hemodynamic changes in each group were analyzed and only a reduction in heart rate and the mean arterial blood pressure was found just before insertion of SAD in relation to the baseline measures. These findings could be explained by the hypotensive effects of propofol and fentanyl that were used for induction of anesthesia. There were no statistically significant differences in the heart rate and the mean arterial blood pressure just after insertion, and 5 or 10 min after insertion.
Comparison between the two groups indicated that there were no significant differences in the heart rate and the mean arterial blood pressure just before induction of anesthesia, before insertion, just after insertion, and 5 or 10 min after insertion.In terms of arterial oxygen saturation, there was no statistically significant difference between the two groups at different intervals, before induction, before insertion, just after insertion, and 5 or 10 min after insertion.
Our results are similar to those of Lee et al. , who found no difference in terms of the mean blood pressure or heart rate between the cLMA and the i-gel group.
Our results are also in agreement with those of Das et al. , who found no significant difference in hemodynamic data between the cLMA and the i-gel group.
In terms of the complications encountered during this comparative study, there was no significant difference between the two groups. In group I (cLMA), there were blood traces on the device after its removal in four (12.5%) patients, two (6.3%) patients developed laryngeal spasm, and one (3.1%) patient developed sore throat, whereas in group II (i-gel), one (2.9%) patient had blood traces on the i-gel after removal and one (2.9%) patient developed laryngeal spasm; none of the patients had a sore throat or hoarse cry.
Das et al.  also found no significant difference between i-gel and cLMA in terms of complications. Only one patient showed blood staining on removal of the i-gel and two patients on removal of the cLMA; none of the patients developed sore throat or hoarse cry in both groups .
Lee et al.  reported that no equipment was stained with blood after device removal in the i-gel group and two patients in cLMA showed blood traces on removal of the device. No significant differences were also found in terms of other side effects (e.g. coughing) between i-gel and cLMA (P=0.75) .
The results of Kim et al. also showed no significant difference between i-gel and cLMA in terms of complications; blood stain was identified in two patients in the i-gel group versus five patients in the LMA group; there was no laryngeal spasm in any patient in both groups, but seven patients in the i-gel group and six patients in the LMA group developed sustained cough.
| Conclusion|| |
Both the i-gel and the cLMA are suitable devices for controlled ventilation for pediatric patients undergoing short surgical procedures who are not at risk of aspiration. Insertion time of i-gel was less than that of cLMA and the airway sealing pressure of the i-gel was higher than that of cLMA. There was no significant difference in hemodynamic data, manipulation, and complications between cLMA and i-gels.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]