|Year : 2022 | Volume
| Issue : 1 | Page : 90-96
Comparison of I-gel and LMA Protector in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
DE Ari1, S Abitagaoglu1, C Koksal1, A YildirimAr1, D Emrem2, M Ustun1
1 Department of Anesthesiology and Reanimation, Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey
2 Department of Anesthesiology and Reanimation, Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, Istanbul, Turkey
|Date of Submission||20-Dec-2020|
|Date of Acceptance||02-Jul-2021|
|Date of Web Publication||19-Jan-2022|
Dr. D E Ari
Department of Anesthesiology and Reanimation, Fatih Sultan Mehmet Training and Research Hospital, E-5 Highway İçerenköy Street 34752 Ataşehir İstanbul
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Aims: Comparison of the use of I-gel and Laringeal Mask Airway (LMA) Protector in laparoscopic cholecystectomy regarding the time and ease of insertion for supraglottic airway devices (SAD) and gastric tube (GT), airway sealing capacity, and postoperative complications. Patients and Methods: Sixty-four American Society of Anaesthesiologists (ASA) I–III patients undergoing laparoscopic cholecystectomy were randomly allocated into two groups. After anesthesia induction, LMA Protector was inserted in Group LPRO (LMA Protector) (n = 33) and I-gel was inserted in Group IGEL (I-gel) (n = 31) patients. Time of SAD insertion, number of attempts, time, and ease of GT insertion were recorded. The peak inspiratory pressure (PIP) and oropharyngeal leak pressure (OLP) were measured at the time of SAD insertion, 10 min after insertion, 10 min after pneumoperitoneum, and just before the termination of pneumoperitoneum. The presence of bloodstains on SAD, sore throat, hoarseness, nausea, and pain in swallowing was assessed postoperatively. A P value of < 0.05 was accepted as statistically significant. Result: Two patients in Group LPRO needed endotracheal intubation and were excluded from the study. The SAD insertion time was shorter in Group IGEL than in Group LPRO (13 ± 7.4 s vs. 18.8 ± 9.8 s). The number of attempts and success rate on the first attempt were similar in both groups. GT insertion time was shorter in Group IGEL than Group LPRO (11 ± 7.7 s vs. 21 ± 11 s). The insertion of GT was easier in Group IGEL. The OLP levels decreased during the pneumoperitoneum in Group LPRO while they remained constant in Group IGEL. Conclusion: We observed that I-gel offers more stable airway sealing and easier GT insertion advantages when compared with LMA Protector in laparoscopic cholecystectomy.
Keywords: Cholecystectomy, laparoscopic surgery, laryngeal masks
|How to cite this article:|
Ari D E, Abitagaoglu S, Koksal C, YildirimAr A, Emrem D, Ustun M. Comparison of I-gel and LMA Protector in Laparoscopic Cholecystectomy: A Randomized Controlled Trial. Niger J Clin Pract 2022;25:90-6
|How to cite this URL:|
Ari D E, Abitagaoglu S, Koksal C, YildirimAr A, Emrem D, Ustun M. Comparison of I-gel and LMA Protector in Laparoscopic Cholecystectomy: A Randomized Controlled Trial. Niger J Clin Pract [serial online] 2022 [cited 2022 Dec 3];25:90-6. Available from: https://www.njcponline.com/text.asp?2022/25/1/90/335992
| Introduction|| |
Over the last decade, supraglottic airway devices (SADs) have been adopted in laparoscopic surgical procedures. They have some advantages over endotracheal intubations: ease of placement, lesser requirement of neuromuscular blockade, more hemodynamic stability, less restricted mucociliary clearance, and lower incidence of postoperative airway morbidity.,,, Especially second-generation SADs protect against pulmonary aspiration due to incorporated gastric channels., The SADs are also effective and life-saving in difficult airway management.
The most important parameter to provide adequate and safe ventilation for the SAD is its sealing effectivity measured as oropharyngeal leak pressure (OLP). Yoon et al. reviewed the articles that compared the competency of SADs used in laparoscopic surgery. The authors suggested that I-gel® (Intersurgical Ltd, Wokingham, UK) is a safe airway tool for laparoscopic surgery patients by providing the highest seal pressure after pneumoperitoneum.
The LMA Protector™ (Teleflex Medical, Co. Westmeath, Ireland) is a recently developed supraglottic airway device made of medical-grade silicone which makes it more flexible and less traumatic than LMA devices made of polyvinylchloride. It has a fixed, curved structure for easier insertion with an inflatable airway cuff. It has two drain channels which emerge proximally as separate ports and enter a chamber behind the cuff bowl. This chamber narrows distally into the orifice located at the end of the cuff. Additionally, the LMA Protector™ is available with a pilot balloon providing easier adjustment and monitorization of the intracuff pressure., Eckardt et al. stated that the LMA Protector provides high pharyngeal seal pressures (28–35 cm H2O) and these pressures are comparable with LMA Proseal and higher than LMA Supreme.
Chang et al. compared the use of LMA Protector and I-gel in paralyzed, anesthetized patients and found that the LMA Protector provides a better airway sealing than I-gel, besides a longer insertion time, and more mucosal injury.
We aimed to compare the use of I-gel and LMA Protector in laparoscopic cholecystectomy regarding the time and ease of insertion for SAD and for gastric tube (GT), airway sealing capacity, and postoperative complications.
| Patients and Methods|| |
The ethical approval of this study was provided by the Institutional Ethical Committee on 12/10/2017. Sixty-four patients with the American Society of Anesthesiologists physical status classification I–III undergoing laparoscopic cholecystectomy under general anesthesia were included in this prospective study. The patients with body mass index (BMI) ≥35, gastroesophageal reflux disease, severe pulmonary disease, preoperative hoarseness, and patients who were expected to have difficult intubation were excluded from the study. Patients younger than 18 years and older than 80 years were also excluded. The patients were informed about the study and their consent was obtained preoperatively. Sternomental length and inter-incisors distance were recorded.
In this parallel study, the patients were randomly allocated into Group LPRO (n = 33): LMA Protector group and Group IGEL (n = 31): I-gel group, using opaque sealed envelopes that were opened just prior to the induction of general anesthesia. An anesthetist who was involved in the study assigned the patients to the groups, inserted the SAD, and recorded the intraoperative data. The patients were unaware of the group they belonged to.
The patients were not premedicated and they fasted for 8 h before surgery. Routine monitoring including electrocardiography, pulse oximetry, non-invasive blood pressure, and bispectral index (BIS) was initiated before the induction of anesthesia. The anesthesia was induced with 2 mcg.kg-1 fentanyl and 2–3 mg.kg-1 propofol. When BIS was score <60%, rocuronium 0.5 mg.kg-1 was given. Following balloon-valve-mask ventilation with 100% oxygen for 2 min, SAD was inserted by the same two experienced anesthesiologists, with the patient's head in the semi-sniffing position. The size of SADs was determined according to the manufacturer's recommendations based on weight. The posterior face of the SADs was lubricated with a water-soluble lubricant before insertion.
A closed circle system was connected (inspired tidal volume 7 mL.kg-1, respiratory rate 12 b.min-1, I:E ratio of 1:2 and fresh gas flow 3 L.min-1). Effective ventilation was defined as a square-wave tracing on the capnograph and normal chest movements. If the first attempt failed, the SAD was inserted with a jaw thrust maneuver or by changing the head position. If the first two attempts failed, different size of SAD was chosen. If the third attempt failed, endotracheal intubation was performed and the patient was excluded from the study. The number of attempts was recorded. The patient was ventilated by a face mask between the attempts. The time of insertion was defined as the time from removing the face mask to the first appropriate capnography trace. Cuff pressure was monitored using a manual manometer to achieve and maintain a level of 60 cm H2O for the LMA Protector.
Mechanical ventilation was adjusted to maintain end-tidal CO2 between 35 and 45 mmHg. Anesthesia was maintained with sevoflurane 1–2% in 50/50% oxygen/air mixture and remifentanil (0.05–0.5 mcg.kg-1.min-1) infusion in order to keep the BIS level between 40 and 60%. A well-lubricated 14 G GT was inserted via the drain tube of the SAD and the ease of inserting was recorded (very easy, easy, difficult, very difficult, impossible). The duration of GT insertion was also recorded.
With the patient's head placed in the neutral position, the OLP was measured by closing the expiratory valve of the circle system at a fixed gas flow of 3 L.min-1. The OLP was deemed to be the pressure in the circuit when an audible noise was heard over the mouth. The OLP and peak airway pressure (PIP) were recorded at the insertion of SAD, 10 min after insertion, 10 min after pneumoperitoneum, and just before the termination of pneumoperitoneum. All the peroperative recordings were taken at reverse Trendelenburg position with the head at 30°. Peritoneal insufflation was set at 13 mmHg. At the end of the surgery, the neuromuscular block was reversed using neostigmine (0.03–0.05 mg.kg-1) and atropine (0.01–0.02 mg.kg-1). The SAD was removed when the BIS was >80% and the patient responded to verbal orders. The patient received ondansetron 4 mg and paracetamol 1 g intravenously at the end of the surgery. The duration of anesthesia, pneumoperitoneum, and surgery was also recorded. The presence of bloodstain on the SAD following the removal was recorded. The patient was evaluated regarding sore throat, hoarseness, and pain in swallowing at the first hour postoperatively. The postoperative data were recorded by an anesthesiologist who was not involved in the study.
Our primary outcome was the OLP level at 10 min after pneumoperitoneum. The sample size was calculated based on the data from a pilot study of 14 patients (7 patients in each group), in which OLP at 10 min after pneumoperitoneum was measured as 27 ± 4.5 cm H2O and 25.43 ± 5.13 cm H2O for LPRO and IGEL groups, respectively. The sample size calculation using the above data at a two-tailed α =0.05 and 80% power, determined that 26 patients were needed to detect statistically significant differences between groups. Considering the possible lack of data, 31 patients were included in each group.
We analyzed the data with SPSS version 16 (SPSS Inc., Chicago, IL, USA). Continuous data were analyzed using the Wilcoxon's test. The Mann–Whitney U test was used for comparison between groups. Nominal data were analyzed with the Chi-square test. A P value less than 0.05 was considered significant.
| Results|| |
A total of 64 patients were allocated for the study between December 2017 and January 2019. In Group LPRO, two patients needed endotracheal intubation because of failed SAD insertion at the third attempt. These patients were excluded from the study [Supplementary Figure].
The age, BMI, sternomental distance, inter-incisors distance of the patients, and duration of anesthesia, surgery, and pneumoperitoneum were similar in both groups [Table 1].
|Table 1: Demographic data, duration of anesthesia, surgery, and pneumoperitoneum|
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The supraglottic airway device insertion time was shorter in Group IGEL than in Group LPRO. The number of attempts and success rate on the first attempt were similar in both groups. GT insertion time was shorter in Group IGEL than Group LPRO. The insertion of GT was easier in Group IGEL. The insertion of GT was impossible in two patients of Group LPRO [Table 2].
No difference was found between the groups regarding PIP levels. In Group LPRO, PIP 10 min after insertion was higher than PIP at insertion, PIP 10 min after pneumoperitoneum was higher than PIP 10 min after insertion, and PIP before the end of pneumoperitoneum was lower than PIP 10 min after pneumoperitoneum. In Group IGEL, PIP 10 min after pneumoperitoneum was higher than PIP 10 min after insertion, and PIP before the end of pneumoperitoneum was lower than PIP 10 min after pneumoperitoneum [Figure 1]. No difference was found between the groups regarding OLP levels. In Group LPRO, OLP 10 min after pneumoperitoneum was lower than OLP 10 min after insertion, and OLP before the end of pneumoperitoneum was lower than OLP 10 min after pneumoperitoneum [Figure 2].
|Figure 1: OLP levels before and during pneumoperitoneum. *P < 0.005 when compared with previous measurement in Group LPRO, & P<0.0005 when compared with previous measurement in Group IGEL, Wilcoxon's test. OLP: Oropharyngeal leak pressure pneumo: pneumoperitoneum|
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|Figure 2: PIP levels before and during pneumoperitoneum. *P < 0.005 when compared with previous measurement in Group LPRO, Wilcoxon's test and P < 0.005 when compared with previous measurement in Group IGEL, Wilcoxon's testPIP: peak inspiratory pressurepneumo: pneumoperitoneum|
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The incidences of bloodstains on the SAD, sore throat, and nausea were similar in both groups.
No patient experienced hoarseness or pain in swallowing during the study [Table 3].
| Discussion|| |
In this study while comparing LMA Protector and I-gel for laparoscopic cholecystectomy, we found that I-gel was inserted faster, the gastric catheter was inserted faster and easier through I-gel, and I-gel provided a more stable OLP during pneumoperitoneum.
The I-gel was inserted more rapidly than the LMA Protector. The difference between the duration of insertion is probably related to the time taken for the insufflation of LMA Protector's cuff balloon. Although the success rate on the first attempt seems to be similar in both groups, the fact that two patients required intubation because of a failed third attempt with LMA Protector should be considered. These two patients were excluded from the study in order to prevent the lack of following data. In a mannequin-based simulation study, emergency nurses succeeded in inserting the I-gel and LMA Protector within the same time. Their performance was independent of their previous experience and education on SADs. Mendonca et al. compared fiberoptic-guided tracheal intubation via I-gel with LMA Protector and found that both SADs allowed fiberoptic intubation with similar ease. On the other hand, the authors highlighted that at the first insertion of SAD, the I-gel was quicker and easier to insert. They remarked that the most common difficulty with the use of LMA Protector was the insertion of the device in the mouth. Chang et al. suggested that I-gel has a better fiberoptic view with less epiglottic folding than the LMA Protector. I-gel has an epiglottic rest in order to prevent the downfolding of the epiglottis or distal opening of the SAD; the LMA Protector has no such component. We did not evaluate the placement of SAD by the fiberoptic view.
Gastric distension and aspiration are the main concerns when using SADs for laparoscopic procedures.
Yoon et al. concluded that I-gel has the lowest GT insertion success among all SADs because of its slender channel that allows insertion of only smaller GTs. This meta-analysis did not include any study on LMA Protector. The LMA Protector has two gastric channels with a larger volume of drainage way. The presence of two gastric channels makes the clinicians expecting a reduced risk of aspiration. Nevertheless, we observed that GT insertion was easier and faster with I-gel than LMA Protector. This result agrees with the study conducted by Chang et al. We used the same size (14 G) of GT for all. The difficulty of GT insertion may be related to the curved shape of the LMA Protector.
A high OLP guarantees airway without leakage, and therefore, is a crucial factor in selecting SAD during laparoscopic surgeries where airway pressure rises due to pneumoperitoneum. Yoon et al. highlighted that I-gel provides the highest OLP level after pneumoperitoneum. They associated this advantage of I-gel with its medical-grade thermoplastic elastomer structure that provides an anatomical seal over pharyngeal tissues. As it reshapes with body temperature, it may not provide a high OLP at the beginning of the surgery, but provides an adequate seal after some time. Sharma et al. compared the respiratory mechanics of LMA Proseal and I-gel in laparoscopic cholecystectomy. Their results showed a higher sealing pressure with LMA Proseal and higher dynamic compliance with I-gel. Choi et al. compared Baska Mask and I-gel in laparoscopic cholecystectomy and found that the Baska Mask offered a higher OLP than I-gel, but the measurement of OLP was taken before pneumoperitoneum. They did not observe the change in OLP after pneumoperitoneum. Sabuncu et al. conducted a study comparing AuraGain and I-gel in laparoscopic cholecystectomy. They found that OLP was similar for both SADs, but as Choi et al., they did not measure OLP after pneumoperitoneum. As we obtained repeated measurements of OLP, we could observe the changements during the study course. In both groups, the PIP increased after the peritoneal insufflation and decreased during the course of pneumoperitoneum. OLP was similar in both groups but it decreased in the LMA Protector group during the pneumoperitoneum, while it remained constant in the I-gel group. This means that the sealing capacity of I-gel was maintained and the LMA Protector weakened during surgery. Mishra et al. evaluated the effect of pneumoperitoneum and Trendelenburg position on the oropharyngeal sealing pressure of I-gel and Proseal LMA in laparoscopic gynecological surgery. They found that OLP was lower with I-gel before and after pneumoperitoneum. In our study, the patients were at reverse Trendelenburg position with the head at 30° up.
Eckardt et al. stated that the LMA Protector provides high pharyngeal seal pressures (28–35 cm H2O). The authors suggested that the pharyngeal seal of the LMA Protector does not change with the extension of the neck. Chang et al. found that the LMA Protector provided a higher sealing pressure than I-gel in patients undergoing non-laparoscopic surgery.
Kang et al. compared the LMA Protector use with endotracheal intubation in laparoscopic cholecystectomy. The authors found that the LMA Protector was as effective as endotracheal intubation in maintaining pulmonary ventilation without disturbances in the peak airway pressure. Postoperative hoarseness and nausea were less frequent with LMA Protector. Sen et al. remarked that the use of I-gel is safer than tracheal intubation in patients with bleeding disorders undergoing laparoscopic surgery, especially in the presence of previous intracranial bleeding history.
As mentioned by Nagahisa and colleagues, endotracheal intubation does not always secure the airway against aspiration. In addition, difficult airway situations may be encountered because of endobronchial intubation which is not uncommon during laparoscopic procedures. One other advantage of the use of SAD in laparoscopic surgeries may be decreased level and duration of postoperative pain. As one of the most important causes of postoperative abdominal pain is the staining and coughing of the patient during the removal of the endotracheal tube, the use of SAD may provide a lower and shorter lasting pain.
Chang et al. found that the bloodstain incidence was higher with LMA Protector than I-gel. In our study, although bloodstains were present in three patients of the LMA Protector group no bloodstains were seen in the I-gel group. The difference was not statistically significant. Nausea and sore throat incidence showed no difference between groups. None of our patients experienced hoarseness nor pain in swallowing.
Timmermann stated that the cuff pressures should be measured and maintained under 60 cm H2O. The use of a cuff manometer helps to reduce respiratory morbidity. I-gel has no cuff which is an essential advantage regarding the tissue damage that the inflated cuff may cause. On the other side, the LMA Protector has a pilot balloon that provides easier adjustment of the intracuff pressure.
One of the limitations of our study is the fact that the anesthesiologists who recorded the intraoperative data could not be blinded to the SAD choice.
Timmermann et al. highlighted that the use of second-generation SADs for expended medications (laparoscopic surgeries, obesity, prone position, cesarean section) seems to be useful and safe when the clinician has adequate clinical experience.
| Conclusion|| |
We found that both LMA Protector and I-gel seem to be appropriate for use in patients undergoing laparoscopic cholecystectomy. We observed that I-gel offers a more stable airway sealing and easier GT insertion advantages.
There is no conflict of interest with any financial organization. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Ethical Committee of Fatih Sultan Mehmet Educational and Research Hospital (İstanbul, Turkey) approved the study on 12/10/2017.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]