ABSTRACT
Background and Aims:
A variety of extraglottic airway devices (EADs) are available. Main concerns with EADs are protection against aspiration and ability to ventilate patients with high airway pressures. Baska mask meets these criteria and is the only third-generation device available for clinical use.
Methods:
After institutional ethics committee approval and informed consent were obtained, this prospective study was performed in 100 adult patients undergoing surface surgeries at a tertiary referral centre. The primary outcome was the success rate of insertion, while the secondary outcomes were the sealing pressure, stability of the device and the perioperative complications of Baska mask. We then compared it with other currently used EADs.
Results:
The first attempt at insertion and overall success rates, showed values of 81% and 98%, respectively. Insertion was quick (median 12; interquartile range [IQR] 9–15 s). The mask sealing pressure, was 35 cmH2O (median [IQR 20–50 cmH2O]). Also, the mask remained stable in 95% of patients intraoperatively. Sore throat and dysphagia were seen in 37% and 24% of patients, respectively. No patient had laryngospasm or desaturation at any time. It compared favourably well with other EADs, while achieving higher sealing pressures.
Conclusion:
We found that the Baska mask performs well with excellent first attempt at insertion and overall success rates, higher sealing pressures and minimal complications compared to currently used EADs in clinical anaesthesia.
Keywords: Airway pressure, Baska mask, complications, dysphagia, extraglottic airway devices, general anaesthesia, hoarseness, laryngeal mask
INTRODUCTION
Airway management was revolutionised after the advent of the laryngeal mask airway (LMA). Since then, many extraglottic airway devices (EADs) have been in clinical use. Baska mask® (Logikal Health products PTY Ltd., Morisset, Australia) is an innovative, recently introduced EAD. Baska mask is made of medical grade silicone, with a thin cuff and pliable diaphragm, and the cuff does not need inflation. It is the first third-generation EAD as per Michálek and Miller[1] classification, with a self-energising expandable cuff, with a variable pressure sealing mechanism.
The data regarding ease and speed of insertion, maximum sealing pressure, intraoperative device stability and perioperative complications of Baska mask is scarce and is derived from small studies; therefore, we evaluated its use, with a focus on these parameters. We then performed a literature review to compare the Baska mask with other currently used EADs.
METHODS
This prospective, single-arm study was conducted in a tertiary referral hospital from May 2018 to January 2019 following institutional ethics committee (vide approval number IEC0218/1987, dated 28 March 2018 and Clinical Trials Registry - India (CTRI) (vide registration no. CTRI/2018/04/013402, www.ctri.nic.in). After obtaining written informed consent from the participants for participation in the study and use of the patient data for research and educational purposes, 100 American Society of Anesthesiologists (ASA) physical status I or II adults, with body mass index (BMI) <30 kg/m2 and adequate mouth opening undergoing elective surface surgery under general anaesthesia were included in the study. Those with a difficult airway, cervical spine disease, sore throat, dysphagia or dysphonia and pregnant women were excluded. An operator, who was a third-year anaesthesiology resident, achieved competency by inserting a Baska mask in 10 patients before the study. She inserted the device in all patients included in the study. The principles of the Declaration of Helsinki, 2013 were followed while conducting the study.
Baseline demographics and Mallampati class were recorded. The anaesthetic technique was standardised. Intravenous (IV) fentanyl 2 μg/kg and propofol 2–2.5 mg/kg were given for induction, followed by atracurium 0.5 mg/kg or vecuronium 0.08 mg/kg for facilitating Baska mask insertion. After facemask ventilation for 3 min, a Baska mask of appropriate size (chosen as per manufacturer’s recommendation) was inserted. Before insertion, the integrity of the device was checked and the posterior surface of the mask was lubricated with a water-based lubricant before insertion. Three attempts were allowed before declaring a failed insertion. In such cases, another EAD or endotracheal tube was inserted. Time required to insert the Baska mask (from device insertion in the mouth till optimal positioning) and the number of attempts were recorded. The optimal position was confirmed clinically and by capnography. Heart rate and blood pressure were measured at baseline and every minute up to 5 min. After securing the airway, sealing pressure was recorded by closing the adjustable pressure-limiting valve and allowing a fixed fresh gas flow rate of 3 L/min. The ventilation was temporarily suspended, and the maximum airway pressure (50 cm of H2O) in the anaesthesia breathing system at which it reached equilibrium or an audible leak was heard was noted. Anaesthesia was maintained with sevoflurane/isoflurane and nitrous oxide/air in 40% oxygen, and the patients were ventilated with volume-controlled mode. Minute ventilation was adjusted to maintain normocarbia.
Intraoperative displacements causing air leak or inadequate ventilation and the need to either reposition or replace the device were recorded. Complications, if any, such as laryngospasm, desaturation and trauma during insertion were recorded. After reversal and mask removal, patients were shifted to the recovery room. One hour later, patients were given a few sips of water and asked about sore throat and/or dysphagia.
The primary outcome was the first attempt insertion and the overall success rate, while the secondary outcomes were maximum sealing pressure, stability of the device and complications such as sore throat and dysphagia. Current literature suggests a 72%–88% first attempt insertion success rate for the Baska mask.[2-6] To detect a first attempt success rate of 80% (with 8% precision [range of 72%–88%] at 95% confidence), a sample size of 97 was needed. We, therefore, included 100 patients in our study.
Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) version 25 (International Business Machines Corp. Armonk, NY, USA). The data were checked for normality of distribution using the Shapiro–Wilk test. A repeated measure analysis of variance (ANOVA) was used to compare changes in haemodynamic parameters every minute starting from baseline up to 5 min. All analyses were two sided, and significance was set at a P value of 0.05.
RESULTS
Of the 100 recruited patients, 58 belonged to ASA class I, while the remaining belonged to ASA II. The mean age was 46.89 ± 12.04 years, and the mean BMI was 23.32 ± 3.35 kg/m2. Seventy-eight patients had Mallampati class I airway (median I, interquartile range [IQR] I–II). The median duration of anaesthesia was 105 (IQR 54-156) min.
Overall successful insertion rate was 98%, while first attempt insertion was achieved in 81%. A second attempt was needed in 15 patients. Of the four patients who required a third attempt, the Baska mask was inserted successfully in two patients, while in one patient, LMA SupremeTM was inserted and in the other, the trachea was intubated. Time required for Baska mask insertion was median 12 (IQR 9–15) s. There was a significant (P < 0.0001) decrease in all haemodynamic parameters (heart rate, systolic, diastolic and mean blood pressure) from baseline. The median sealing pressure in most patients (98%) was at least 35 cmH2O (IQR 20–50 cmH2O). It was >40 cmH2O in 39% of patients and reached 50 cmH2O in 16% patients.
In five patients, the Baska mask got displaced intraoperatively (probably because of change in head position, i.e. head turned away to the other side), which was evident either from inability to ventilate or an audible leak. In two patients, the mask was repositioned, while in two cases, LMA Supreme was inserted and one patient was intubated. Postoperatively, in two patients, blood staining of the mask was seen. Thirty-six patients (37%) complained of sore throat, while 23 patients had dysphagia. There were no other complications.
DISCUSSION
Baska mask was easy and quick to insert with an overall successful insertion rate of 98%, and first attempt insertion of 81%.
The overall success rates of insertion of Baska mask ranged from 88% to 98%, while the first attempt insertion ranged from 76.7% to 89%.[2-4] Alexiev et al.[3] described a lower first attempt success rate, with quite a few patients requiring second and even a third attempt. The study conducted by Aziz et al. revealed that the insertion success rate for Baska mask was similar to ours.[5] This is similar to the first attempt success rate of classic LMA, LMA Unique, LMA Flexible, Proseal LMA and I-gel, except Supreme LMA [Table 1].
Table 1.
Overall successful insertion rates of EADs
| Extraglottic airway device | Author (year) | Success rate | No. of attempts |
|---|---|---|---|
| Baska mask | Mahajan et al.[4] (2018) | 96.59% | First attempt 88.23% Second attempt 100% |
| Baska mask | van Zundert and Gatt[2] (2012) | NR | First attempt 88% Second attempt 10% Third attempt in 2% |
| Baska mask | Alexiev et al.[3] (2012) | 96.7% | First attempt 76.7% Second attempt 13% Third attempt 10% |
| Baska mask | Aziz et al.[5] (2017) | 96.7% | First attempt 90% Second attempt 6.7% |
| Baska mask | Current study (2019) | 98% | First attempt 81% Second attempt 15% Third attempt 2% Failed 2% |
| Baska mask | Tosh et al.[6] (2021) | 94.45% | First attempt 67.5% Second attempt 22.5% |
| Baska mask | Kara and Sarikas[12] (2019) | 95% | First attempt 95% Second attempt 5% |
| Classic LMA | Kömür et al.[13] (2015) | NR | First attempt 90% Second attempt 10% |
| LMA Unique | Eglen et al.[14] (2017) | 93.3% | First attempt 88.3% |
| LMA Flexible | Koo et al.[11] (2019) | NR | First attempt 93.7% |
| Supreme LMA | Tan et al.[7] (2010) | 100% | First attempt 96% Second attempt 100% |
| Proseal LMA | Hwang et al.[8] (2009) | 94% | First attempt 85%0 Second attempt 8% Third attempt 1% |
| I-gel | Kannaujia et al.[9] (2009) | 100% | First attempt 90% Second attempt 10% |
EAD – Extraglottic airway device; LMA – Laryngeal mask airway; NR – Not reported
Aziz et al. compared I-gel, another EAD with non-inflatable cuff, with Baska mask for controlled ventilation in obese patients (BMI 34.7 ± 3 kg/m2; Baska mask group versus I-gel group: 34.1 ± 3.4 kg/m2) during ambulatory surgery and found a higher overall success rate of insertion of Baska mask. They used a larger size (4-6) of Baska mask than that used for patients in the current study who had lower BMIs (23.3 ± 3.32 kg/m2). For the same reason, their insertion time was higher than in the current study.[5] These insertion rates are comparable to the success rates for Proseal LMA, I-gel and Supreme LMA.[7-9]
Various studies on Baska mask have found the time to be as short as 11.0–23.9 s [Table 2], depending on the study population. In the study by Mahajan et al.,[4] the insertion of Baska mask was also quick. Unlike others, Tosh et al.[6] reported a significantly longer time to insertion with Baska mask compared to I-gel. Similarly, Abedini et al.[10] reported a quick overall placement time for classic LMA, while it was found to be slightly longer for insertion of LMA Unique.[10] In Koo et al.’s study, the insertion time for LMA Flexible using standard technique was shorter,[11] while it was longer for Supreme LMA.[13] Proseal LMA and I-gel were found to have an similar average insertion time in other studies.[8,9] From all these studies, it appears that Baska mask can be inserted as quickly as any other EAD [Table 2].
Table 2.
Time to successful insertion of various EADs
| Extraglottic airway device | Author (year) | Time for insertion (Mean±SD), s |
|---|---|---|
| Baska mask | Mahajan et al.[4] (2018) | 11.02±2.11 |
| Baska mask | van Zundert and Gatt[2] (2012) | 16±6 |
| Baska mask | Alexiev et al.[3] (2012) | 23.9±13.3 |
| Baska mask | Aziz et al.[5] (2017) | 19.6±8.4 |
| Baska mask | Current study (2019) | 12 (9–15) |
| Baska mask | Tosh et al.[6] (2021) | 45.3±12.6 |
| Baska mask | Kara and Sarikas[12] (2019) | 14 (6–25) |
| Classic LMA | Abedini et al.[10] (2018) | 8.43±10 |
| LMA unique | Eglen et al.[14] (2016) | 11.78 (6–24) |
| LMA flexible | Koo et al.[11] (2019) | 10.5±4.7 |
| Supreme LMA | Tan et al.[7] (2010) | 15 (12–18.4) |
| Proseal LMA | Hwang et al.[8] (2009) | 10±7 |
| I-gel | Kannaujia et al.[9] (2009) | 11 (8–45) |
EAD – Extraglottic airway device; LMA – Laryngeal mask airway; SD – Standard deviation
The ability to achieve high airway sealing pressure (oropharyngeal leak pressure) is important with EADs, as it allows positive pressure ventilation at high pressures, which may be useful in patients with obesity, those with low respiratory compliance and those undergoing laparoscopic surgery. It also prevents pulmonary soiling in the event of regurgitation of gastric contents.
In the present study, 55% of patients had sealing pressures >40 cmH2O, while the median pressure was 35 (IQR 20-50) cmH2O. While immediate post-insertion pressure was 30 cmH2O in all the patients, it went up to 40 cmH2O in a higher number of patients in the study by van Zundert and Gatt,[2] which might have been due to better placement of Baska mask ensured by fibreoptic examination. Also, they measured the sealing pressure 30 min after insertion of the device, which may have been because of moulding of the mask to the shape of the hypopharynx of the patient, leading to a better seal and thus higher pressure. High sealing pressures have also been reported by other investigators.[3,12] In comparison, other EADs have much lower sealing pressures. First-generation EADs have much lower sealing pressures and while the second-generation devices have higher sealing pressures than the first-generation EADs, they are still lower than what we found with the Baska mask [Table 3].
Table 3.
Sealing pressures achieved with various EADs
| Extraglottic airway device | Author (year) | EADs studied, number of patients | Sealing pressure (cm of H2O) mean±SD or median (IQR) |
|---|---|---|---|
| Baska mask | van Zundert and Gatt[2] (2012) | Single arm, 50 patients | >30a |
| Baska mask | Alexiev et al.[3] (2012) | Single arm, 30 patients | 35.7±13.3 |
| Baska mask | Aziz et al.[5] (2017) | I-gel versus Baska mask 30 obese patients each | 28.6±2.9 |
| Baska mask | Chaudhary et al.[15] (2018) | I-gel versus Baska mask 50 each, 100 patients | 33.54±1.16 |
| Baska mask | Our study (2019) | Single arm, 100 patients | 35.48 (±9.45) |
| Classic LMA | Qamarul Hoda et al.[16] (2017) | CLMA, 30 patients | 26±3 |
| LMA Unique | Francksen et al.[17] (2007) | LMA Unique, Ambu LM and Soft Seal LMA 40 patients each | 18 (14–21)b |
| LMA Flexible | Koo et al.[11] (2019) | LMA Flexible Single device, 129 patients | 20.5±4.2 |
| Supreme LMA | Tan et al.[7] (2010) | 100 patients | 25 (±6.5) |
| Proseal LMA | Qamarul Hoda et al.[13] (2017) | 53 patients | 30±4.57 |
| I-gel | Kannaujia et al.[9] (2009) | Single arm, 50 patients | 20 (16–40) |
| Chaudhary et al.[15] (2018) | I-gel versus Baska mask 50 each, 100 patients | 25.97±2.25 | |
| Aziz et al.[5] (2017) | I-gel versus Baska mask 60 obese patients, 30 each | 25.8±3.2 |
CLMA – Classic laryngeal mask airway; EAD – Extraglottic airway device; IQR – Interquartile range; LMA – Laryngeal mask airway; SD – Standard deviation, a>30 in all patients, 40 cmH2O in 82% patients. bSize 4, inflated with 30 mL air
The incidence of sore throat and dysphagia at 1 h postoperatively in our study was similar to those reported by other authors [Table 4]. Blood staining of Baska mask occurred in only two of our patients (2.04%), while none had trauma. This is similar to the results of some studies on Baska mask, but higher than that reported in van Zundert and Gatt’s[2] study. The higher incidence of oropharyngeal morbidity in our study may have been because of longer duration (105 [IQR 40–300] min) of surgeries. The differences can also be attributed to differences in assessment of laryngopharyngeal morbidity [Tables 4 and 5].
Table 4.
Postoperative complications with the use of Baska mask
| Complications | Author (year) | Incidence |
|---|---|---|
| Sore throat | Van Zundert and Gatt[2] (2012) | 10% |
| Al Rawahi et al.[20] (2013) | 43.3% | |
| Current study (2019) | 37.1% | |
| Dysphagia | van Zundert and Gatt[2] (2012) | 2% |
| Al-Rawahi et al.[20] (2013) | 20% | |
| Current study (2019) | 23.7% | |
| Hoarseness of voice/dysphonia | van Zundert and Gatt[2] (2012) | Nil |
| Al Rawahi et al.[20] (2013) | 20% | |
| Current study (2019) | NA | |
| Blood staining of device | van Zundert and Gatt[2] (2012) | 8% |
| Alexiev et al.[3] (2012) | 23.3% | |
| Current study (2019) | 2.04% | |
| Desaturation | Alexiev et al.[3] (2012) | 3.3% |
| Intraoperative displacement | Current study (2019) | 5.10 |
No reports of aspiration, nerve injury or major trauma
Table 5.
Postoperative complications with other EADs
| Complications | EAD | Author (year) | Incidence |
|---|---|---|---|
| Aspiration | Classic LMA | Michalek et al.[21] (2015) | 2.3 per 10,000 cases |
| I-Gel | Michalek et al.[21] (2015) | Three cases reported | |
| Supreme LMA | Michalek et al.[21] (2015) | No cases reported | |
| Laryngospasm | I-Gel | Michalek et al.[21] (2015) | 1.2% |
| Blood staining of device | Classic LMA | Michalek et al.[21] (2015) | 12%–15% |
| Proseal LMA | Michalek et al.[21] (2015) | 9%–22% | |
| I-Gel | Michalek et al.[21] (2015) | 4%–13% | |
| Supreme LMA | Tan et al.[7] (2010) | 7% | |
| Sore throat | Classic LMA | Michalek et al.[21] (2015) | 5.8%–34% |
| Supreme LMA | Tan et al.[7] (2010) | 7% | |
| Proseal LMA | Hwang et al.[8] (2009) | 25% | |
| I-Gel | Michalek et al.[21] (2015) | 5%–17% | |
| Dysphagia | Classic LMA | Kömür et al.[13] (2015) | 50% |
| Nerve injury | Classic LMA | Thiruvenkatarajan et al.[18] (2015) | Recurrent laryngeal nerve 13 reports, lingual nerve injury 14 cases, hypoglossal nerve injury nine cases |
| Supreme LMA | Tan et al.[7] (2010) | Lingual nerve neuropraxia 1% | |
| Proseal LMA | Brimacombe et al.[19] (2005) | Recurrent laryngeal nerve injury 11 reports, lingual nerve injury five reports, hypoglossal nerve injury six reports | |
| I-Gel | Thiruvenkatarajan et al.[18] (2015) | Lingual nerve injury two reports |
EAD – Extraglottic airway device; LMA – Laryngeal mask airway
The limitations of our study are that it is a single-centre, single-arm study, in which the Baska mask was inserted by a single operator. The results in terms of first attempt success rate would be different if multiple operators with varied experience would have inserted the masks.
CONCLUSION
Baska mask performs well with excellent first attempt and overall success rates, and with higher sealing pressures, good stability and minimal complications.
Financial support and sponsorship
Funds were granted for this research by Tata Memorial Center, Homi Bhabha National Institute, Mumbai, via TMC-Research Administrative Council (TRAC).
Conflicts of interest
There are no conflicts of interest.
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