|Ahead of print publication
Comparison of I-gel™ versus Baska mask® on oropharyngeal sealing pressure in patients receiving general anesthesia under spontaneous ventilation: A randomized controlled trial
Bhimala Naga Ramya1, Sandeep Kumar Dav1, Sivakumar Segaran1, D Sivaramakrishnan2, Mamie Zachariah1, RV Ranjan3
1 Department of Anesthesiology, Pondicherry Institute of Medical Sciences, Puducherry, India
2 Department of Anesthesiology, Indira Gandhi Medical College and Research Institute, Puducherry, India
3 Department of Anesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Puducherry, India
|Date of Submission||12-Oct-2022|
|Date of Decision||19-Dec-2022|
|Date of Acceptance||20-Dec-2022|
|Date of Web Publication||02-Mar-2023|
Sandeep Kumar Dav,
Department of Anesthesiology, Pondicherry Institute of Medical Sciences, Ganapathichettikulam, Kalapet, Puducherry - 605 014
Source of Support: None, Conflict of Interest: None
Background: Baska mask® is a newer third-generation supraglottic airway device (SAD) having a self-sealing membranous cuff that does not require inflation. Oropharyngeal sealing pressure (OSP) is used to quantify the efficacy of airway sealing in SAD. Our primary objective was to compare OSP between Baska mask® and I-gel™ in patients receiving general anesthesia on spontaneous ventilation. The secondary objectives were to determine the ease, duration, number of attempts during insertion, hemodynamic responses, and perioperative complications.
Methodology: Fifty patients scheduled for a variety of surgical procedures lasting up to 90 min under general anesthesia were randomly allocated to one of the two groups, Group B (Baska mask®) and Group I (I-gel™). Data were collected and entered into an Excel sheet. Statistical analysis was performed using SPSS. Statistical tests used were Student's unpaired t-test, Mann–Whitney U-test, and Fisher's exact test. P < 0.05 was considered statistically significant.
Results: The OSP was significantly higher in Group B than in Group I (29.4 ± 6.01 vs. 26.32 ± 4.26 cmH2O, respectively) (P = 0.042). The number of attempts, mean duration, and grade of ease of insertion in both groups had no statistical difference. Hemodynamic parameters were not significantly different between both groups. No postoperative complications were noticed in either group.
Conclusion: Baska mask® offers a superior airway sealing pressure compared to I-gel™ without significant hemodynamic changes, with equal first-pass success rate and postoperative complications.
Keywords: Day care, general anesthesia, hoarseness, laryngeal masks
|How to cite this URL:|
Ramya BN, Dav SK, Segaran S, Sivaramakrishnan D, Zachariah M, Ranjan R V. Comparison of I-gel™ versus Baska mask® on oropharyngeal sealing pressure in patients receiving general anesthesia under spontaneous ventilation: A randomized controlled trial. J Curr Res Sci Med [Epub ahead of print] [cited 2023 Mar 31]. Available from: https://www.jcrsmed.org/preprintarticle.asp?id=370928
| Introduction|| |
Day-care surgeries are steadily increasing in many countries across the world. Anesthesia for day-care surgeries focuses on perioperative care, where minimal airway manipulation without muscle paralysis is one of the preferred anesthetic techniques.
Supraglottic airway devices (SADs) have been increasingly used nowadays since they are less invasive and cause less discomfort in the postoperative period. An ideal SAD must have high airway seal pressures during positive pressure ventilation, also low resistance to the flow of gases during spontaneous ventilation with a low incidence of pulmonary aspiration and complications.
The I-gel™ is a second-generation supraglottic device with a noninflatable cuff exerting a slight pressure on the pharyngolaryngeal structure to provide a perilaryngeal seal and a gastric drain tube facilitating aspiration of gastric contents. Baska mask® is a newly designed third-generation SAD with a self-inflating cuff that improves the seal during intermittent positive pressure ventilation and a drain sump posteriorly acting as a reservoir for pooled secretions or aspiration of gastric contents providing better airway protection.
Although different SADs have been compared against each other on various parameters, comparison between the I-gel™ and the Baska mask® has not been investigated enough in terms of their performance and suitability among adult patients receiving general anesthesia on spontaneous ventilation.
The primary objective of our study was to compare the oropharyngeal sealing pressure (OSP) of the Baska mask® and I-gel™ as airway devices in patients receiving general anesthesia on spontaneous ventilation. The secondary objectives were to find out the ease of insertion, time taken for insertion of SAD, any manipulation required for correct positioning of SAD, number of attempts, hemodynamic responses during insertion of airway device, and perioperative complications between Baska mask® and I-gel™.
| Materials and Methods|| |
This is a prospective randomized clinical trial approved by the Institutional Ethics Committee (IEC/RC/18/64), dated November 2, 2018, and registered with the Clinical Trial Registry of India (CTRI/2019/08/020691), dated October 29, 2018. The study was conducted from October 2018 to April 2020. With written informed consent, 50 patients of both genders scheduled for various elective minor surgeries under general anesthesia were enrolled in this study. Patients between 18 and 60 years of age, American Society of Anesthesiologists (ASA) physical status I–II, and Modified Mallampati grade I–II were included. Patients requiring emergency surgeries, intra-abdominal surgeries, reactive airway disease, pregnancy, history of gastroesophageal reflux disease (GERD), sore throat, difficult airway, mouth opening <5 cm, and body mass index (BMI) >30 kg/m2 were excluded.
Patients were randomized into two groups based on computer-generated simple randomization: Group I (n = 25) for I-gel™ and Group B (n = 25) for Baska mask®. On the day of the surgery, the sealed envelopes containing the allocated group were handed over to the investigator.
All the patients received standardized premedication of tablet Ranitidine 150 mg, tablet Metoclopramide 10 mg, tablet Lorazepam 1 mg night before surgery, fasted 6 h before surgery, and received tablet Ranitidine 150 mg, tablet Metoclopramide 10 mg two hours before surgery with sips of water. On arrival at the operation theater, an 18G intravenous (IV) access was secured, connected to multipara monitors, and baseline parameters (noninvasive blood pressure, oxygen saturation [SpO2], and heart rate) were recorded. Choosing the size of SADs has been decided by the patient's body weight and the manufacturer's recommendations. Both I-gel™ (Intersurgical Ltd. Wokingham, Berkshire, UK) and Baska mask® (Logikal Health Products Pty Ltd, Morisset, NSW, Australia) were lubricated on the posterior surface and the tip, using a water-based gel (KY jelly), before the insertion of the device.,
Patients were placed in a sniffing position, pre-oxygenated for 3 min with 100% oxygen after premedication using intravenous (IV) Injection Midazolam 0.03 mg/kg, Injection Glycopyrrolate 0.01 mg/kg and Injection Fentanyl 2 μg/kg. Induced with IV Injection Propofol 2 mg/kg, maintained with Sevoflurane, Oxygen, and Nitrous Oxide.
After achieving an adequate depth of anesthesia, the SAD (I-gel™ or Baska mask®) was inserted by anesthesiologists with >5 years of experience. To ascertain the correct placement of SAD, the patient ventilation was assisted to see for bilateral equal chest rise, end-tidal carbon dioxide (EtCO2) waveform, and lack of gastric distension in the epigastric area were assessed. Time taken for the insertion, number of attempts, OSP, and hemodynamics after insertion were recorded.
In both groups, when it was difficult to insert the SAD in the first attempt, the following maneuvers were followed: chin lift to open the airway along with jaw thrust and head extension or flexion of the neck was done. In the case of the Baska mask®, the position was adjusted by pushing up or pulling down the device by the tab provided on the ventral surface. When the insertion of SAD failed on the first attempt, two more attempts were allowed. If the third attempt failed, the plan was to either intubate or awaken the patient, depending on the clinical situation. The ease of insertion was assessed using a 4-point scale. 1 – Easy insertion on the first attempt with no need for adjustment, 2 – Slight difficult insertion on the first attempt with at least one adjustment maneuver, 3 – Obvious difficult insertion on the second attempt, and 4 – More than two attempts or no SAD insertion.
The OSP was measured by maintaining a constant fresh gas flow rate of 5 L/min (O2:N2O in 1:1), gradual closure of the adjustable pressure-limiting (APL) valve of the anesthetic circuit, and recording the pressure on the airway pressure gauge of anesthesia machine when an audible leak was heard around the SAD. In patients in whom the airway pressure reached 40 cmH2O without any leak, the leak test was interrupted by opening the APL valve, and a value of 40 cmH2O was recorded.,
The heart rate, blood pressure, EtCO2, and SpO2 were recorded at the time of insertion and every minute for the first 5 min and then every 5 min for 15 min after successful insertion. Oxygen and nitrous oxide were given for the maintenance of anesthesia in a 50:50 ratio with sevoflurane (2%–4%) to a minimum alveolar concentration of 1–1.5. The patient's ventilation was assisted manually whenever EtCO2 rises >45 mmHg to maintain EtCO2 in the range of 35–40 mmHg during spontaneous ventilation. Thereafter, anesthesia was maintained with spontaneous ventilation. After completion of the surgery, the I-gel or the Baska mask® was removed after the patient became awake and had a gag reflex. During extubation, we looked for any laryngospasm and evidence of blood on the device or in the mouth during suction. Five minutes of postoperative oxygenation was given before shifting the patient to the recovery room. During the first 24 h postoperatively (i.e., half an hour, 2nd h, 4th h, 6th h, and 24 h), the patient was assessed for sore throat and was graded using a 4-point scale. 0 – No sore throat, 1 – Mild sore throat (complaints of sore throat only on asking), 2 – Moderate sore throat (complaints of sore throat on his/her own), and 3 – Severe sore throat (change of voice or hoarseness associated with dysphagia and dysphonia).
The sample size calculation was done using Epi Info version 7.0 software by taking OSP as an outcome measure of interest from the study of Aziz et al. From the above study, we required 19 participants per group to detect the difference in the means of OSP of 2.8 cmH2O between the two groups, standard deviations of 3.2 cmH2O in Group I and 2.9 cmH2O in Group B with 80% power, and a level of significance of 5%. Accounting for 10% dropout, the sample size was rounded off to 25 in each group.
Statistical analysis was performed using SPSS version 23.0, Chicago, IL, USA (trial version). The statistical tests used were unpaired Student's t-test for OSP, Mann–Whitney U-test for the duration of insertion, and Fisher's exact test for the grade of ease of insertion. P < 0.05 was considered statistically significant.
| Results|| |
Fifty-five patients were assessed for eligibility, four patients were excluded due to refusal, and one patient was excluded due to a history of GERD and sore throat [Figure 1]. The two study groups were comparable in age, sex, BMI, Mallampati grade, ASA status, type of surgery, and duration of surgery [Table 1].
The OSP was high in Group B (29.4 ± 6.01 cmH2O) than in Group I (26.32 ± 4.26 cmH2O) and was statistically significant (P = 0.042) [Figure 2].
|Figure 2: The mean oropharyngeal sealing pressures of I-gel and Baska mask|
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Both airway devices were successfully placed on the first attempt with a 100% success rate. Of 25 patients, ease of insertion was Grade 1 in 22 (88%) and Grade 2 in 3 (12%) in both groups. The mean duration of insertion was relatively longer in Group B (13.80 ± 11.27 s) than in Group I (13.28 ± 10.72 s) but was statistically insignificant (P = 0.865) [Table 2]. Although there was an increase in the heart rate and mean arterial pressure (MAP) postinsertion when Baska mask® was used, there was no statistically significant difference found using the unpaired t-test [Figure 3]. No postoperative complications were noticed in either group.
|Table 2: Comparison of size of the device, number of attempts, and ease and duration of insertion|
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|Figure 3: Comparison of hemodynamic changes following SAD insertion in both groups (a) Mean HR changes, (b) Mean arterial blood pressure changes. SAD: Supraglottic airway device, HR: Heart rate, MAP: Mean arterial pressure|
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| Discussion|| |
In our study, we found that in Baska mask® group, five patients had a sealing pressure of 31 and 40 cmH2O, but none of the patients in the I-gel™ group had OSP above 30 cmH2O [Table 3]. When these two groups were compared, the mean OSP pressure in the I-gel™ group was 26.32 cmH2O, and the mean airway sealing pressure in Baska mask® group was 29.4 cmH2O, which was found to be statistically significant with P = 0.042. This showed that oropharyngeal sealing with Baska mask® was better compared to I-gel™. Our findings are similar to those in a study done by Aziz et al. In their study, they compared I-gel™ with Baska mask® in obese patients undergoing ambulatory surgery and concluded that both I-gel™ and Baska mask® are suitable for ventilation in obese patients, and Baska mask® has a better laryngeal seal compared to I-gel™. Similar sealing pressures with Baska mask® have been described in earlier studies by Priya et al. and Sidhu et al.,
Sachidananda et al. compared the Baska mask® with I-gel™ in patients undergoing minor surgical procedures; the first-time success rate of the Baska mask® was 21/24 (87.5%) compared to that of the I-gel™, which was 23/25 (92%). They attributed that lower success rates achieved with the Baska mask® were due to the morphology and the uniqueness of the device, which may require more expertise. However, in our study, we found that in both the groups, the SADs were placed in the first attempt (i.e., 100%) with an ease of insertion score of 1 in 88% and a score of 2 in 12% of patients. There was no statistically significant difference between the two groups concerning ease of insertion. Even though Baska mask® is a relatively newer SAD, in our study, we found insertion was as easy as with I-gel™.
The duration of insertion of I-gel™ was 13.28 ± 10.72 s, and the duration of insertion of Baska mask® was found to be 13.80 ± 11.27 s (not statistically significant, P = 0.865); I-gel™ took lesser time to insert than Baska mask® similar to study by Sachidananda et al.
During the insertion of SAD, the pressor response (i.e., increase in heart rate and arterial pressure) may be induced due to the pressure produced in the larynx and the pharynx by the noninflatable cuff and dome of SAD. In this study, there was no statistically significant difference between I-gel™ and Baska mask® groups concerning heart rate, systolic, diastolic, and MAP, arterial saturation, and EtCO2. There was no desaturation in any patient. The EtCO2 did not show obstructed traces at any time. The results of our study were similar to the studies done by Fotedar.
During the removal of SAD, the hemodynamic response is probably triggered by pharyngeal stimulation during reverse rotation of the cuff; it can also lead to laryngospasm on emergence, sore throat, and a bloodstain on the device. After extubation, we watched for laryngospasm and looked for evidence of blood on the device or in the mouth during suctioning. Patients were asked about sore throat postoperatively for 24 h and were graded similarly to the Al-Rawahi et al.'s study. In our study, none of the patients had any of these complications.
Limitations of our study are unable to use a fiberoptic bronchoscope, real-time ultrasonography, and follow-up of OSP. Choosing an ideal SAD should be based on the correct size, adequate seal, higher sealing pressures for better ventilation, and fiberoptic confirmation as a norm if available, which could have been done in our study. Gastric insufflation could be assessed using real-time ultrasonography. Follow-up of OSP could have been done throughout the surgery, as in a study done by Alexiev et al. This may have shown us if the same measurement of OSP stayed consistent throughout the case or improved with time. Multi-regression analysis could have been done to associate the size of the device, BMI, and age of the patient with OSP.
| Conclusion|| |
Both Baska mask® and I-gel™ are effective in maintaining an airway in spontaneously ventilating patients. However, Baska mask® offers superior OSP compared to I-gel™ while both devices have a similar ease of insertion and first-attempt success rates.
The authors would like to thank Dr. Sagiev Koshy George, Ex-HOD and Professor, Department of Anesthesiology, Pondicherry Institute of Medical Sciences, for his continuous support as departmental chair.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3]