Introduction- In case of general anesthesia, airway maintenance along with least complications is the most important goal of team of anesthesiologists. In clinical practice, laryngeal mask airway (LMA) devices demonstrate superiority in the management of supraglottic airways. The i-gel airway has recently been introduced as supraglottic airway apparatus. Hence the present study was done to compare between I -gel and fastrach LMA regarding intra operative management pros and cons and post op sore throat. Material and methods- This prospective randomised comparative study involved 50 adult patients (ASA I–II) undergoing elective surgeries under general anaesthesia. Patients were randomly divided into two groups: Group I (I-gel, n = 25) and Group F (LMA Fastrach, n = 25). The parameters evaluated encompassed insertion characteristics, intra-operative airway functionality, and post-operative airway complications. A standardised grading scale was used to rate sore throats after surgery at 1, 6, and 24 hours. We used SPSS version 25.0 to do the statistical analysis, and p < 0.05 was considered significant. Results- The two groups' baseline characteristics and demographic data were similar. Age, gender distribution, body mass index, ASA physical status, and length of operation did not differ statistically significantly (p > 0.05), suggesting proper group matching. In comparison to the Fastrach LMA group, the I-gel group showed a considerably greater first-attempt success rate (92%) and a shorter mean insertion time (14.2 ± 3.1) (p < 0.05). I-gel produced a considerably higher airway sealing pressure and a reduced incidence of air leak (24.6 ± 3.2 cm H₂O) (p < 0.05). The Fastrach group also required airway adjustment more frequently. At every time point measured, the I-gel group's incidence of post-operative sore throat was consistently lower. At one and six hours after surgery, the difference was statistically significant (p < 0.05). Conclusion- Compared to LMA Fastrach, I-gel works better during surgery and causes less airway problems after surgery. It is the best supraglottic airway device for routine elective surgeries because it is easy to insert, makes a good airway seal, and causes fewer sore throats after surgery. LMA Fastrach is still useful when intubation through a SAD is needed.
Endotracheal intubation is the regular procedure followed for delivering anaesthesia for various types of surgeries, foreign body removal from the airways, to visualize the abnormalities in airways, so on and so forth. The process typically is sensitive that it may sometimes lead to complications like distortion of upper airway while reaching the glottis. [1] Further, endotracheal intubations are comparatively complex to perform in facial trauma and high larynx patients. [2] Supraglottic airway device (SADs), a novel invention by Brain A, et al. [1993] has become revolutionary alternative solution to overcome the aforesaid issues by filling the airway gaps and improving the ease of tracheal intubation. [3] These SADs are designed so ergonomically that they provide more safety by reducing the risk of aspiration and offer better pharyngeal sealing. [4]
Laryngeal mask airway (LMA) Fastrach was invented in 1997 as a further development of the classic laryngeal mask airway.[5,6] It was designed for use as a ventilatory device, and in conjunction with a dedicated ETT, as a conduit for blind tracheal intubation while maintaining ventilatory properties of the classic LMA (cLMA). The main reason that prompted its introduction was that it overcomes the length limitations of tracheal tube. Moreover, it does not require intraoral digital manipulation or head and neck manipulation for placement and the epiglottis is elevated from the intubating path. It permits single handed intubation without moving head from neutral position and has become a valuable tool in management of anticipated and unanticipated difficult airway. [7]
The I-gel is SGA composed, single gel like soft, non inflatable cuff that is composed of a elastomer made of thermoplastic. It consist of flattened broad, stem with hard bite block that serves as stabilizer buccally in order to deduce rotation axial as well as mal-positioning, and also a slot for insertion of gastric tube. It is a instrument that is free of latex and does not need insertion digitally into the mouth of patient Moreover, it is cheaper as compared to other SGAs.[8]
There were several comparative clinical studies to understand the differences, advantages, and disadvantages between proseal LMA and i-gel. Comparison of fastrach LMA and I gel is yet to be explored further to optimize the use of airway devices.
The present prospective randomized comparative hospital-based study was conducted at department of Anaesthesiology at a tertiary care hospital for a period of one year. Ethical clearance for conducting the research was taken from institutional ethics committee of college and hospital before commencement of study. Patients were asked to sign an informed consent form after explain them about the study process. Through consecutive sampling a total of 50 patients undergoing elective surgery under general anaesthesia were selected for the study on the basis of inclusion and exclusion criteria. Inclusion criteria- 1.Patients aged 18–60 years 2.American Society of Anesthesiologists (ASA) physical status I and II 3.Elective surgeries of duration ≤ 2 hours 4.Patients requiring airway management with supraglottic airway device 5.Mallampati class I or II Exclusion criteria- 1. Patients with anticipated difficult airway 2. ASA physical status III or IV 3. Body mass index (BMI) > 30 kg/m² 4. Risk of aspiration (gastro-oesophageal reflux disease, full stomach, pregnancy) 5. Upper respiratory tract infection or sore throat preoperatively 6. Head and neck pathology or limited mouth opening Patients were randomly divided into two groups • Group I (I-gel group):25 patients- Airway secured using I-gel supraglottic airway device • Group F (Fastrach LMA group): 25 patients - Airway secured using Fastrach laryngeal mask airway Procedure- All patients received a comprehensive pre-anesthetic evaluation, encompassing airway assessment (Mallampati grading, mouth opening, neck mobility), standard laboratory investigations, and a systemic examination. As per standard guidelines, patients were not allowed to eat or drink anything. When the patient arrived in the operating room, standard monitoring began. This included electrocardiography (ECG), non-invasive blood pressure (NIBP), pulse oximetry (SpO₂), and end-tidal carbon dioxide (EtCO₂). Vital signs were taken at the beginning. After pre-oxygenation for 3 minutes, anaesthesia was started with intravenous propofol 2 mg/kg). According to institutional protocol, muscle relaxation was achieved using atracurium. After the anaesthesia was deep enough, the assigned supraglottic airway device was put in place. Airway device insertion- • I-gel: A properly sized I-gel was chosen based on the patient's weight and put in according to the manufacturer's instructions, without inflating the cuff. • Fastrach LMA: The standard rotational technique was used to put in a Fastrach LMA that fit well, and the cuff was filled with air according to the recommended amounts. The following things were noted : • Number of insertion attempts • Time taken for successful insertion (from picking up the device to appearance of first square EtCO₂ waveform) • Ease of insertion (graded as easy, moderate, or difficult) • Need for airway manipulations (jaw thrust, head extension, repositioning) Intraoperative assessment- After the assigned supraglottic airway device was successfully placed, monitoring continued throughout the surgery. Baseline and regular intra-operative measurements of haemodynamic parameters such as heart rate, non-invasive blood pressure, oxygen saturation (SpO₂), and end-tidal carbon dioxide (EtCO₂) were taken. The adequacy of ventilation was evaluated by examining chest expansion, capnographic waveform, and the preservation of target EtCO₂ levels. We measured the airway sealing pressure to see how well the airway seal worked, and we also noted any audible air leaks or gastric insufflation. It was noted that airway manipulations like head repositioning, jaw thrust, or reinserting the device were necessary. Any problems that happened during the operation, such as coughing, laryngospasm, desaturation, regurgitation, or device displacement, were noted and handled according to standard procedures. We looked at how stable and effective the airway device was during surgery to see how the I-gel and Fastrach laryngeal mask airway worked. Postoperative assessment - After the airway device was taken out, a post-operative assessment was done to see how well the patients were breathing on their own and how well their protective airway reflexes were working. The airway device was checked for blood stains, which were noted as a sign of damage to the mucosa. Patients were assessed in the post-anesthesia care unit for airway-related complications, focussing on the frequency and intensity of post-operative sore throat. A standardised grading scale was used to rate sore throat at 1, 6, and 24 hours after surgery. The scale ranged from no sore throat to severe symptoms that made it hard to swallow or were accompanied by hoarseness. There were also other problems after surgery, such as a hoarse voice, trouble swallowing, coughing, nausea, and vomiting. These assessments facilitated a comparative analysis of post-operative airway morbidity between the I-gel and Fastrach laryngeal mask airway cohorts. Data were entered into Microsoft Excel and analyzed using SPSS version25.0. Continuous variables were represented as mean ± standard deviation and analysed using Student’s t-test. Categorical variables were represented as frequencies and percentages and analysed using the Chi-square or Fisher’s exact test as suitable. A p-value of less than 0.05 was deemed statistically significant.
Table 1. Demographic and Baseline Characteristics of Study Participants
|
Parameter |
Group I (I-gel) (n=25) |
Group F (Fastrach LMA) (n=25) |
p-value |
|
Mean age (years) |
38.6 ± 9.4 |
40.1 ± 8.7 |
0.54 |
|
Gender (M/F) |
14 / 11 |
13 / 12 |
0.78 |
|
Mean BMI (kg/m²) |
23.4 ± 2.6 |
23.9 ± 2.8 |
0.48 |
|
ASA I / II |
16 / 9 |
15 / 10 |
0.77 |
|
Duration of surgery (min) |
68.2 ± 14.5 |
70.6 ± 15.1 |
0.61 |
The two groups' baseline characteristics and demographic data were similar. Age, gender distribution, body mass index, ASA physical status, and length of operation did not differ statistically significantly (p > 0.05), suggesting proper group matching.
Table 2. Airway Insertion Characteristics
|
Parameter |
Group I (I-gel) |
Group F (Fastrach LMA) |
p-value |
|
First attempt success (%) |
23 (92%) |
19 (76%) |
0.04* |
|
Second attempt required |
2 (8%) |
6 (24%) |
|
|
Mean insertion time (seconds) |
14.2 ± 3.1 |
21.6 ± 4.8 |
<0.001* |
|
Ease of insertion (Easy/Moderate/Difficult) |
20 / 5 / 0 |
14 / 8 / 3 |
0.03* |
*Statistically significant
In comparison to the Fastrach LMA group, the I-gel group showed a considerably greater first-attempt success rate (92%) and a shorter mean insertion time (14.2 ± 3.1) (p < 0.05). In the I-gel group, a higher percentage of patients evaluated the insertion process as "easy," while Fastrach LMA was more commonly associated with moderate to difficult insertion.
Table 3. Intra-operative Airway Performance and Complications
|
Parameter |
Group I (I-gel) |
Group F (Fastrach LMA) |
p-value |
|
Mean airway sealing pressure (cm H₂O) |
24.6 ± 3.2 |
22.1 ± 3.5 |
0.02* |
|
Air leak (%) |
2 (8%) |
6 (24%) |
0.04* |
|
Need for repositioning (%) |
3 (12%) |
7 (28%) |
0.05* |
|
Intra-operative coughing |
1 (4%) |
4 (16%) |
0.16 |
|
Desaturation episodes |
0 |
1 (4%) |
0.31 |
When compared to Fastrach LMA, I-gel produced a considerably higher airway sealing pressure and a reduced incidence of air leak (24.6 ± 3.2 cm H₂O) (p < 0.05). The Fastrach group also required airway adjustment more frequently. Coughing and desaturation were rare intraoperative consequences that did not demonstrate statistical significance in either group.
Table 4. Post-operative Sore Throat Incidence
|
Time Interval |
Group I (I-gel) |
Group F (Fastrach LMA) |
p-value |
|
1 hour |
3 (12%) |
9 (36%) |
0.04* |
|
6 hours |
2 (8%) |
7 (28%) |
0.05* |
|
24 hours |
1 (4%) |
5 (20%) |
0.08 |
At every time point measured, the I-gel group's incidence of post-operative sore throat was consistently lower. At one and six hours after surgery, the difference was statistically significant (p < 0.05). Sore throat was more common in the Fastrach LMA group, even though it only lasted for 24 hours in a tiny percentage of patients.
Table 5. Severity of Post-operative Sore Throat
|
Severity Grade |
Group I (I-gel) |
Group F (Fastrach LMA) |
|
No sore throat |
22 (88%) |
16 (64%) |
|
Mild |
3 (12%) |
6 (24%) |
|
Moderate |
0 |
3 (12%) |
|
Severe |
0 |
0 |
The majority of patients in the I-gel group did not develop sore throats following surgery. On the other hand, mild to moderate sore throat was more common in the Fastrach LMA group. There were no instances of severe sore throats in either group.
Extensive knowledge on alternative airway devices plays a decisive role in controlling the airway during anesthesia for the patients at a risk of difficult intubation or ventilation. Though the problem is not common in majority of the cases, it is advisable to be prepared for the alternative airway device during anesthesia administration to avoid possible risk of critical intubation. [9,10]
In the present study compared to the Fastrach LMA group, the I-gel group demonstrated a significantly higher first-attempt success rate and a reduced mean insertion time. In the I-gel cohort, a greater proportion of patients assessed the insertion procedure as "easy," whereas the Fastrach LMA was more frequently linked to moderate to difficult insertion. In comparison to Fastrach LMA, I-gel demonstrated a significantly elevated airway sealing pressure and a diminished occurrence of air leak. The Fastrach group necessitated more frequent airway adjustments. Coughing and desaturation were infrequent intraoperative outcomes that lacked statistical significance in both groups.
Contrary results were found in a study conducted by Kapoor et al, first-attempt success rate for blind tracheal intubation was comparable in both the groups and overall success rate was higher in F group as compared to I group, which is similar to the results of Halwagi et al and Sastre et al who noticed higher success rate of blind tracheal intubation with ILMA. This could be due to a “V” shaped tracheal tube guiding ramp in LMA Fastrach that centralizes the ETT towards the glottic aperture as the ETT emerges from the metal shaft and guides it anteriorly to reduce the risk of arytenoids trauma and oesophageal placement and the presence of the handle in LMA Fastrach which resulted in stabilization and manipulations which could not be done in i-gel. [11-14]
In a study conducted by Bhole et al., it was found that air leak pressure in the present study showed that in the i-gel group it was higher when compared to the LMA group which is statistically significant. This indicates that the sealing capacity of i-gel made of thermoplastic elastomer is better and it fits better in supraglotic anatomy since it is a second generation device with advanced technology. Much of the literature says that both the devices are more or less same in performance yet i-gel has emerged as the preferable device over LMA in majority of the cases. [15,16]
In our study at each measured time point, the incidence of post-operative sore throat in the I-gel group was consistently reduced. Sore throat occurred more frequently in the Fastrach LMA group, however it persisted after only 24 hours in a small minority of patients. Mild to moderate sore throat was more prevalent in the Fastrach LMA cohort. No occurrences of severe sore throats were observed in either group.
Study conducted by Jamal et al., found that A sore throat developed in 17 instances (14.2%), with 4 cases (6.7%) in the i-gel group and 13 cases (21.7%) in the LMA group. The difference between the two groups was substantial (p<0.05).[17] Soliveres et al. demonstrated through their case studies that postoperative sore throat occurred in 3.4% of persons in the I-gel group, compared to 28.6% in the LMA group. A notable change was seen (p<0.05). The people in the LMA group exhibited more dysphagia and sore throat compared to those in the I Gel group. The I-gel mask was recommended.[18]
Jadhav et al. conducted a randomised trial revealing that postoperative sore throat occurred in 3.3% of patients in the I-gel group, compared to 16.7% in the LMA group. An inconsequential difference was noted (p=0.085).[19] Helmy et al. conducted another trial that supported this case study, indicating that postoperative sore throat was observed in 37.5% of people in both the I-gel group and the LMA group. The little difference was seen (p=0.34).[20] Polat et al. demonstrated through a randomised experiment that postoperative sore throat occurred in 1.7% of patients in the I-gel group, which was identical to the 1.7% incidence in the LMA group. The negligible difference was noted t (p=0.752).[21] Dasgupta et al. presented contentious conclusions. In their randomised experiment, the incidence of sore throat at 2 hours was approximately 18% in persons using disposable LMA, compared to 6% in those using the i-gel group. The difference was substantial, namely p<0.05.[22]
Our findings suggest a practical point: I-gel may be the better choice as a primary SAD in elective cases because it is usually easier to insert, provides stable ventilation with good seal characteristics, and is linked to less early post-operative sore throat. On the other hand, LMA Fastrach is still a useful tool for intubation, especially when managing a difficult airway is expected or unexpected and intubation through a SAD is needed, even if this means more throat pain in some cases. User experience, cuff pressure management, and anaesthesia technique can all affect the results of a study. Future studies with larger samples and standardised cuff pressure monitoring (in the Fastrach group) may help to make the differences in airway morbidity clearer.
This study demonstrates that the I-gel supraglottic airway device is more effective during surgery compared to the Fastrach laryngeal mask airway. The I-gel demonstrated a superior success rate on the initial attempt, reduced insertion time, and enhanced airway sealing pressure, resulting in more steady ventilation. The I-gel reduced the likelihood of air leaks and airway manipulations occurring during surgery. Post-surgery, individuals administered I-gel had a consistently lower incidence and severity of sore throats. Both devices were secure and functioned effectively for airway management during elective procedures. Nevertheless, the non-inflatable cuff and anatomical design of the I-gel appear to contribute to a reduction in airway morbidity. According to these findings, I-gel may surpass Fastrach LMA for standard airway control during surgical procedures