One of the fundamental skills of an anesthesiologist is management of the airway. Most of anesthesiologists are very familiar and skilled at managing the adult airway successfully but since children are not small adults and pediatric patient’s airway differ from adult as they have significant anatomical, physiological, pathological differences, securing airway in pediatric patients demands more expertise in airway management which includes different skills, tools and approaches.1

Endotracheal intubation is gold standard technique in airway management but LMAs are also used safely and effectively in pediatric patients since 1990 both for controlled and spontaneous ventilation.2 In current scenario, LMAs are recommended for use in a variety of challenging scenarios, such as in the difficult airway, remote locations, ventilation during resuscitation, long-duration surgeries and even in laparoscopic surgeries and prone position procedures.3

Over many years, Classic LMA was used for securing pediatric airway but condemned for insertional difficulties, airway trauma and also low-pressure seal leading to inadequate positive pressure ventilation, risk of aspiration and gastric sufflation.4 LMA Proseal is styled LMA which aids in insertion and also has advantages of improved ventilation characteristics due specially designed cuff and gastric drainage tube which prevents gastric insufflation and pulmonary aspiration. 4 I – gel was introduced in 2007 by Dr. Nasir. It was designed as latex free second generation Supraglottic airway device (SAD) with innovatively shaped and non-inflatable cuff made of styrene ethylene butadiene styrene (SEBS) which takes the shape of larynx according to anatomy due thermostatic ability.5 Present study was aimed to compare ease of placement and Perioperative Complications of supraglottic airway device in I-GEL and LMA – Proseal in pediatric patients posted for infraumbilical surgeries.

Present study was Prospective randomized controlled single blind study, conducted in department of anaesthesiology, at XXX medical college & hospital, XXX, India. Study duration was of 2 years (December 2020 to December 2022). Study was approved by institutional ethical committee.

Inclusion criteria

• Patients of either sex, aged between 2 to 12 years, ASA I or II posted for elective surgeries i.e., infra-umbilical surgeries of duration less than 2 hours under general anesthesia with controlled ventilation, parents willing to participate in present study

Exclusion criteria

• Patients with limited mouth opening (less than 2 cm) and with anticipated difficult intubation
• MPG III and IV
• Patients at increased risk of aspiration, or having a history of symptomatic gastro- esophageal reflux or hiatus hernia.
• Symptoms related to laryngo-pharyngeal anomaly.
• Musculoskeletal abnormalities affecting the cervical vertebrae.
• ASA Physical Status < II
• Patient undergoing elective surgery of < 2 hours duration under general anaesthesia
• Weight >5kg and <25kg

A day before the scheduled operation, the patients were visited preoperatively in wards for a preanesthetic checkup. Patient characteristics including age, sex, weight, and height were recorded. After obtaining the history, performing a clinical examination and reviewing laboratory investigations which included complete blood count, random blood sugar, kidney function test. Written informed consent for surgery, anesthesia, and participation in the study was taken from parents. All patients were kept nil by mouth (NBM) for 2 hours for clear fluid and 6 hours solid food before the start of anesthesia.

On the day of surgery, NBM and parent’s consent was checked. Intravenous cannula was inserted a night before surgery. Baseline vitals i.e., SPO2, heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP) were checked outside OT. Then child was sedated outside OT with intravenous Inj. Glycopyrrolate 4mcg/kg +Inj. Midazolam 0.02mg/ kg + Inj. Ketamine 1mg/kg. After adequate sedation, patient was shifted inside OT table. On OT table, 100% oxygen was be given with face mask and Pediatric Bain’s circuit. Simultaneously, multipara monitor was attached to patient and HR, SBP, DBP, ECG, Spo2 were recorded. Infusion of Ringer Lactate 2% was started for maintained as per Holiday Segars formula. Pre-oxygenation was done with 100% oxygen. Meanwhile, all patients were further premedicated Inj. Fentanyl 2 mcg/kg iv.

Anesthesia was induced with Inj. Propofol 2mg/kg iv and after confirmation of mask ventilation Inj. Atracurium 0.5mg/kg iv was given as muscle relaxant to facilitate SAD insertion. The patient’s lungs were manually ventilated with 100% oxygen and Sevoflurane 1.5% -2% for 3 minutes by face mask with Pediatric Bain’s circuit.

Patients were randomly allocated in two groups using predetermined computer-generated random allocation plan.

Group I: 50 patients taken for I-GEL

Group P: 50 patients taken for LMA-Proseal

An appropriate size of SAD either I- gel or LMA - Proseal selected as per manufacture guidelines (according to weight). SAD either I – gel or LMA- Proseal was then inserted by the anesthesiologist who has experience in anesthesia for minimum 2 years. SAD for the insertion was selected as per randomization. Position for insertion of SAD - was performed in sniffing position.

Under adequate depth of anesthesia, allocated device was inserted by senior anesthetist. In Group A, the I-GEL of size 1.5 or 2 was inserted according to the manufacturer's instructions. In Group B, the LMA Proseal was inserted. Size of 1.5 and 2.

At the end of the operation, anesthetic agents will be discontinued. On return of spontaneous respiration, reversal given Inj. Neostigmine 0.05 mg/kg and Inj. Glycopyrrolate 8 ug/kg. The device was removed after the patient regains consciousness and responds to verbal command to open the eyes. Further patient was monitor as per routine protocol.

Parameters measured were

Heart rate, Systolic Blood pressure and Diastolic Blood pressure, Mean Airway Pressure, End-tidal CO2 tension, Oxygen saturation (SpO2) & ECG at baseline, after induction of anesthesia and during and after insertion of device, at regular intervals during surgery and after removal of device. During the attempt of insertion if patient developed the complication like desaturation, laryngospasm, bronchospasm then airway was secured with endotracheal tube.

Data was collected and compiled using Microsoft Excel, analysed using SPSS 23.0 version. Frequency, percentage, means and standard deviations (SD) was calculated for the continuous variables, while ratios and proportions were calculated for the categorical variables. Difference of proportions between qualitative variables were tested using chi- square test or Fisher exact test as applicable. P value less than 0.5 was considered as statistically significant.

100 patients were divided as in Group I-50 patient and Group P- 50 patient. The mean age of patients in group I was 5.25 ± 2.97 years and in group P 5.24 ± 2.80 years. Maximum patients were in between and 1 to 3year age in both the groups.  

In group I, 88% of patients were male and 12% of patients were female. In group P, 72% of patients were male and 28% of patients were female. In group-I mean weight was 12.5 ± 9 kg and in group- P, it was 12.5 ± 9.14 kg. Majority of patients were in between 5 - 10 kg weight in both groups. Herniotomy was most performed surgery in both groups with Urethroplasty being second most performed procedure & both groups are comparable in this regard.

Table 1: General characteristics

Mean size ± SD used in I group is 1.8± 0.24 and in group P is 1.74 ± 0.25, difference was not significant statistically. In Group I, out of 50 patients 47 patients had successful insertion and 3 patients had failed to insertion. In Group P, out of 50 patients 40 patients had successful insertion and 10 patients had failed to insertion. The difference between the group was statically significant (p value = 0.037, HS).

Time required for successful insertion in Seconds in group I Mean ±SD is 27.23 ± 4.00 sec. and Time required for successful insertion in Second in group P Mean ±SD is 33.47 ± 2.69 sec. First attempt successful insertion rate with I-Gel was 65.96% and LMA-Proseal was 60% and Second attempt successful insertion rate with I-Gel was 34.04% and LMA-Proseal was 40%. The difference between the 2 group for statically significant.

Table 2: Comparison between I-GEL and LMA – Proseal

In I-GEL group, were 4% of patients had oral injury, 2% of patients had dental injury, 6% of patients had incidence of desaturation, 2% patients developed laryngospasm, 2% patients had bradycardia. In LMA -Proseal group, 4% of pediatric patients had oral injury, 6% patients had dental injury, 12% patients had incidence of desaturation, 4% patients developed laryngospasm, 10% patients had bradycardia in LMA-Proseal group.

 Table 3: Comparison between Complications during the Successful Insertion

The mean time for Nasogastric tube insertion through in I gel Group is 24.89 ± 2.10 and LMA Proseal (P) group was 33.41 ± 3.06. Nasogastric tube insertion success rate for the airway device in Group I & in Group P was 100% in first attempt. The results were found to be statistically not significant.

Table 4: Comparison of Nasogastric Tube insertion

Intraoperative Complication in Group I-GEL (I) and LMA Proseal (P). In Group I, 4% patients developed desaturation, 2% had dislodgment of I-Gel and required repositioning of I-Gel. In LMA-Proseal, 10% patients developed desaturation, 2% had dislodgement of LMA- Proseal and required repositioning of LMA-Proseal. (p value >0.5).

Table.5: Intra Operative Complications between I-Gel (I) and LMA- Proseal (P)

The changes in Mean Heart Rate, Mean Systolic Pressure, Mean diastolic Pressure, Spo2, Mean Airway Pressure & mean ETCO2 were statistically insignificant in both groups at all-time intervals.

Complication during or after Removal of I-GEL (I) and Proseal (P). include cough in 5 patients in I-GEL Group and 6 patients in LMA Proseal. Patients with Dysphagia complaint in I-GEL group was 3 and with LMA Proseal was 3. Patient with Laryngospasm in I-GEL Group was 1 and with LMA Proseal was 1. Patient with blood stain in I-GEL Group was 3 and with LMA Proseal was 5.

Table 6: Incidence of Complications in I-Gel (I) and LMA-Proseal (P) after removal

Post-Operative complication up to 24hr. In which include cough in 2 patients in I-GEL Group and 3 patients in LMA Proseal with P value of 0.388. Patients with sore throat complaint in I-GEL group was 3 and with LMA Proseal was 4 with P value of 0.727. Patients with hoarseness complaint in I-Gel group was 2 and with LMA-Proseal was 3 with value of 0.388. Patients with Dysphagia complaint in I-Gel group was 3 and with LMA-Proseal was 3.

Table 7: Follow for any Complications up to 24 hr. In Group I-Gel(I) And LMA- Proseal(P)

The most important work of anesthesiologist to maintain the airway, adequate oxygenation and ventilation to the patient during time of surgery even the short interval of time, it will be a life threating.

Now a days use of supraglottic airway devices has been in an increase. SADs are replacing endotracheal tube for airway management. Endotracheal tube produces a stress response in patient. The plane of anesthesia needed for inserting endotracheal tube is much deeper and almost always muscle relaxant is required. But for insertion of supraglottic device does not require deep plan of anesthesia as it required for endotracheal tube.

The airway of the pediatric patients is different from adult airway in many aspects and difficult to secure airway in pediatric patient. For securing an airway in pediatric patients, it is important to have knowledge of the anatomical, physiological differences and pathological conditions related to pediatric airway. It is also important for an anesthetist to have the various tools and techniques developed for securing of pediatric airway

The incidence of difficult intubation is 0.07%-0.7% in children and 24%-4.7% in infants.6 Supraglottic airway devices are mainly inserted blindly into the airway and having high success rate of providing oxygenation and ventilation even with the limited training. 1st generation SAD like classic LMA has a risk of gastric insufflation and pulmonary aspiration but with 2nd generation SAD which has separate gastric drain tube for insertion of nasogastric tube reduces chances of the gastric insufflation and pulmonary aspiration.7

We observed that, overall success rate of insertion with I -Gel 94% and with LMA-Proseal was 80%. (p value =0.037). In our study, the successful insertion of I-GEL observed in 47 patients out of 50 patients whereas 3 patients required endotracheal intubation. The successful insertion of LMA- Proseal observed in 40 out of 50 patients whereas 10 patients required endotracheal intubation to secure airway.

Sanket B et al.,8 observed 100% overall success rate with I-GEL and LMA- Proseal both. Saran S et al.,1 also observed similar overall success rate i.e.,100% with both I-GEL and LMA- Proseal. Goyal et al.,3 study shows the overall success rate with I-GEL size 2 pediatric patient was 95% in 40 patients as compared to other supraglottic airways devices (LMA Proseal and LMA supreme) in the study. Shivashi P et al.,9 observed the 100% overall success insertion rate for LMA -Proseal and 100% for I-Gel.

I- gel could be inserted successfully in first attempt in 31 patients (62%) out of 50 patients however, LMA- Proseal could be inserted successfully I in first attempt in 24 patients (48%) out of 50. Difference between two groups was statistically significant (p < 0.5). However, our findings does not corelate with Saran S et al.,1 who observed higher success rate for 1st attempt insertion i.e. 86.07% with I-GEL and 93.3% with LMA- Proseal (p 0.67). Also, Sanket B et al.,8 observed higher success rate for 1st attempt insertion with I-GEL (95.1%) and LMA- Proseal (96.3%). Ashraf N et al.,10 observed, in 95% success rate for first attempt insertion for I-Gel and 77.5% in LMA-Proseal in 40 patients in each group which corelate with our study. It was statically significant (0.05%).

Out of 50 pediatric patients, 1st attempt successful insertion with I-GEL was 31 patients and 2nd attempt successful insertion was 16 patients. However, 3 patients out of 50 required endotracheal intubation as Igel could not successful inserted in IIrd attempt. (p value =0.566) Out of 50 pediatric patients, Ist attempt successful insertion with LMA Proseal was 24 patients and with IInd attempt successful insertion was 16 patients. However, 10 patients out of 50 required the endotracheal intubation because the LMA-Proseal could not be inserted in 3rd attempt.

Saran S et al.,1 needed 2nd attempt for successful insertion in 4 out 30 pediatric patients with I-Gel. 2 out of 30 with LMA-Proseal pediatric patients. Their size of study population was smaller than our study population. Goyal et al.,3 study shows the successful insertion of LMA Proseal size 2 pediatric patient was 90% in 40 patients as compared to other supraglottic airways devices (I-GEL & Classic LMA) in the study.

Ashraf N et al.,10 study shows compared the total number of attempts that were made to insert I-Gel and LMA-Proseal laryngeal mask airway and it was found that 38 patients (95%) had successful supraglottic airway device insertion in a single attempt and 2patients (5%) had success in second attempt in group I-Gel. In group LMA-Proseal, 31 patients (77.5%) had a successful device insertion in a single attempt and 9 patients (22.5%) had success in second attempt.

Time required for successful insertion of I-GEL in our study was 27.23 ± 4.00sec. and for LMA Proseal was 33.47 ± 2.69 sec in 50 pediatric patient in each group. Clinically LMA Proseal group take a much more time as compared to the I-GEL Group due to it required time for cuff inflation, like I-GEL doesn’t have in cuff for inflation. (p value = 0.0001). We compared our study with the Saran S et al.,1 study in which time required for successful insertion of I-GEL group in pediatric patient was 17.2±7sec and for LMA Proseal group in pediatric patient was 15.4±6 sec. In our study time required for insertion both SADs was much longer than Saran S et al.,1 study as, in our study IInd attempt for successful insertion required in 16 pediatric patients in both I-Gel and LMA Proseal group. On the Contrary, study of Saran S et al. in which few patients required IInd attempt of insertion. In Ashraf N et al.,10 study, Igel had a mean duration of 15.2 seconds and LMA-Proseal laryngeal mask airway had a mean duration of 26.1seconds. P value was <0.001 which was statistically significant.

In our study, we were able to insert feeding tube via I in I-GEL 1st attempt in 47 out of 47 patients. There were no failures in our study. Mean Time required for insertion of Nasogastric tube through I-GEL were 24.89 ± 2.10 sec. In the study, we were able to insert feeding tube via LMA Proseal1st attempt in 40 out of 40 patients. Mean Time required for insertion of Nasogastric tube through LMA Proseal were 33.41 ± 3.06sec. We observe in our study that, the time required for insertion of Nasogastric tube through the LMA Proseal take more time as compare to the I-GEL because I-Gel has Anatomical shape which was statistically significant (P value =<0.0001).

Patel MG et al.,11 reported that the success rate of feeding tube in the first attempt was 100% via LMA Proseal in pediatric patient undergoing elective lower abdominal surgeries under general anesthesia. Bhandari G et al.,12 study shows the successful gastric tube placement was possible overall in 92.22% of patients out of 90 and Ist attempt insertion successful rate was 66.66%. [34] The Nasogastric tube placement was 100% successful in both the groups in our study. In Richez et al.,13 study where the gastric tube was successfully inserted in all cases.

There was no incidence of aspiration and regurgitation in either group during induction of anesthesia, in intraoperative period or after the removal of the respective airway device. Similar findings found in the study of Gasteiger L et al.,5 and Shin Wet al.,14 study respectively when they compared I-GEL and LMA- Proseal in pediatric patients.

In I-Gel group, 4% pediatric patients developed cough, 6% has sore throat, 4% has hoarseness, 6% has dysphagia. In LMA - Proseal group, 6% of patient developed cough, 8% has sore throat, 6% has hoarseness, 6% has dysphagia.

In Haw G et al.,15 study, sore throat developed immediate after removal of I-GEL in 4% patients, 30% patients of LMA - Proseal out of 50 patients in each group. dysphagia developed in 6% patient and 4% patient had hoarseness in LMA-Proseal in 50 patient group. Mukadder S et al.,16 study blood contamination was observed in 5 patients in LMA-Proseal and none was observed in i-gel group. Post-operation evaluation, sore throat was not observed in the i-gel group but was observed in 9 patients in LMA-Proseal group, this difference was statistically significant (p value 0.007). Hoarseness and dysphagia were not observed for the i-gel but were present for LMA-Proseal [1 (2.9%) and 6 (17.1%)] groups, the values were not statistically significant. In Jadhav P et al., 17 study, in Group I-Gel 10% patients developed cough, 3% developed the sore throat and with Group LMA – Proseal, 6% patients developed laryngospasm and 16% patients developed sore throat. (p value 0.08).

I-Gel is a safe and suitable supraglottic airway device as compared to LMA -Proseal in pediatric patients for controlled ventilation as judged by better success rate of insertion with less insertion attempts stable hemodynamics, good oxygenation, adequate ventilation and lesser incidence of perioperative complications.

Conflict of Interest: None to declare

Source of funding: Nil

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