INTRODUCTION
Laparoscopic surgery is among the most frequent procedures conducted across the globe. Along with surgical advancements, anaesthesia techniques have also evolved to satisfy the emerging demand for laparoscopic surgeries. Supraglottic airway devices (SADs) became a common airway adjunct alongside preexisting endotracheal intubation as anaesthesia techniques evolved. SADs are now replacing endotracheal intubation in patients requiring positive pressure ventilation.[ 1 ]
Maintaining a patent airway will always be a major concern for an anaesthesiologist during general anaesthesia.[ 2 ] The efficiency as well as safety of the SAD and endotracheal intubation (ETT) were compared in several randomised controlled trials (RCTs) It was observed that the SAD reduces the occurrence of some postoperative airway problems. However, both endotracheal tubes and SADs are commonly used but have their own demerits. Due to the sharing of the laryngeal inlet and oesophagus by laryngeal mask airway (LMA) there is an increased risk of aspiration and regurgitation.[ 3 ] On the other hand, laryngospasm, postoperative hoarseness and elevated haemodynamic parameters are seen with endotracheal intubation .[ 4 ] Park et al .[ 5 ] conducted a meta-analysis in 2016 on laparoscopic surgeries comparing endotracheal tubes and LMA. They included 17 studies and reporting was done on device insertion time, sore throat, laryngospasm, gastric insufflation pressure, regurgitation, nausea, vomiting, cough and bradycardia.
In this research, we attempt to to evaluate the frequency of airway complication in detail, with SADs as well as endotracheal intubation in patients who underwent laparoscopic surgeries.
METHODS
The research was prospectively registered in PROSPERO (ID: CRD42021272957) dated 16.09.2021. This systematic review and meta-analysis were reported according to the guidelines of the 2009 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).[ 6 ]
Eligibility criteria
The following selection criteria were employed: prospective RCTs comparing the usage of SADs and ETTs in adult patients having laparoscopic surgery from at least two independent groups. All chosen publications offered adequate information to pool data on the prevalence of respiratory difficulties using SAD and ETT. Animal studies, articles not published in English and articles whose full text was not available were not included. Systematic review, literature review, scoping reviews, case reports, editorials and conference abstracts were excluded. Studies including paediatric patients and Baska mask® (Proact Medical Ltd, Frenchs Forest NSW, Australia) were also excluded. The studies were also excluded if the study methods and design were not properly stated and reported, or inadequate data was mentioned. Studies were synthesised on well-formulated Population, Intervention, Control, Outcome Study design [Table 1 ].
Table 1: PICOS statement
We have undertaken the analysis based on available data in the individual studies. We have not imputed any data for analysis.
Search strategy
Two authors (TK and BB) separately searched the PubMed database and Google Scholar for related papers written in English and printed from database inception through January 2000 till August 2022. Variations that emerged were resolved by discussions. The search phrases comprised ‘laryngeal mask airway’, ‘LMA’, ‘supraglottic device’, ‘endotracheal intubation ’, ‘ETT’ and ‘laparoscopic surgery’. Authors also reviewed previous meta-analysis for inclusion of studies. The same two writers read the names and abstracts of possibly related papers. All included research reference lists were manually checked, and related review papers were examined to find suitable papers. Another reviewer (SS) independently assessed and decided the articles, to be included in the final analysis. PRISMA flow chart is shown in Figure 1 . Search strategy is shown in Supplementary Table 1 . PRISMA -S check list is shown in Supplementary Figure 1 .
Figure 1: PRISMA flow chart
Supplementary Table 1: Search strategy
Supplementary Figure 1: PRISMA – S checklist
Data collection process
Two independent authors went through all the selected articles. Authors did independent and thorough data extraction from the articles and summarised it in a Microsoft Excel spreadsheet using a standardised data extraction form. The data were gathered from each paper: the name of first author, publication year, country, sample size, type of intervention used and surgery performed. Our departmental research committee concealed article title, author names and journal name and gave a number to each article. Copies of these articles were then distributed to authors. Authors were blinded to the article’s title, journal name and authors. Complications of the airway after anaesthesia (coughing, hoarse voice, sore throat, nausea, vomiting, stridor) were noted as per the article code numbers. Nausea was reported in seven studies while vomiting was studied in eight studies. Vomiting is recorded as an event and collected as nominal data. Patients reported the incidence in the form of yes or no for vomiting. Nausea was reported by patients as nominal data in some studies,[ 4 , 7–10 ] while in others, the event was measured as per visual analogue scale.[ 11 , 12 ] The data were collected from those studies who reported these events independently.
Outcome measures
All the RCTs included in our study had airway complications as secondary outcomes. It was difficult for us to decide the primary outcomes. Sore throat, hoarseness, nausea, vomiting, cough and stridor were the endpoints.
Primary outcome: The primary endpoint was sore throat and hoarseness. These two complications are the most common adverse events reported with any airway manipulation.
Secondary outcome: Stridor and cough are less frequently reported after endotracheal intubation . Owing to their rare occurrences, they have been chosen as secondary outcomes. Nausea and vomiting are not directly related with upper airways. However, they have occurred more frequently with general anaesthesia and endotracheal intubation . In view of these reasons, the secondary endpoints included cough, nausea, vomiting and stridor.
Quality assessment of individual studies
The full-text papers were separately evaluated by the two authors (TK and SS) to assess if they were relevant to the present meta-analysis.
Both authors independently assessed risk of bias assessment for included RCTs using Review Manager Software version 5.4.1 (RevMan version 5.4.1), Copenhagen, The Nordic Cochrane Centre and The Cochrane Collaboration 2020).[ 13 ] They assessed the included studies regarding selection bias, performance bias, detection bias, attrition bias, reporting bias and other bias by evaluating random-sequence generation, allocation concealment, participant blinding, blinding of outcome assessor, incomplete outcome data and selective reporting in individual studies. The internal validity of the study was assessed by rating the above parameters as either ‘high’, ‘low’ and ‘some concern’ risk of bias. If there was a discrepancy between these evaluations, the problem was rectified by discussing it with the senior author (SK).
Statistical analysis
We computed the pooled risk ratio (RR) with 95% confidence interval (CI) for the binary outcome data using random-effect model or fixed-effect models, depending on the heterogeneity. P value less than 0.05 considered as statistically significant. For all outcomes, RRs with 95% CIs were computed. We have presented the results with 95% CI, P values and associated forest plots. Egger’s test and funnel plot-based analysis of the possibility of publication bias were also performed on fixed-effect models [Supplementary Figure 2 ]. GRADE analysis was performed for appraisal of individual studies shown in Supplementary Figure 3 . We also planned to assess the credibility of effect modification.
Supplementary Figure 2: Egger’s test and funnel plot-based analysis
Supplementary Figure 3: GRADE analysis
All the statistical analyses were carried out using software RevMan version 5.4.1 (Copenhagen, The Nordic Cochrane Centre, The Cochrane Collaboration 2020).[ 13 ]
Assessment of heterogeneity
Pooled binary data were analysed using random-effect model in case of heterogeneity more than 50%; otherwise, fixed-effect model was examined by seeing the i 2 statistics. A P value 0.10 for the Cochran Q statistics indicates significant heterogeneity.[ 14 ] In case of high heterogeneity, subgroup analysis will be done to find the cause.
RESULTS
Search results and study selection
A database search was performed in August 2022, and total 31 studies were assessed for eligibility, including 12 from the previous meta-analysis. After excluding review articles, case reports, editorials, conference abstracts, clinical opinions and comments, total 21 articles were included in the final analysis as outlined in the PRISMA flowchart [Figure 1 ]. Twelve articles were included from the previous meta-analysis done by Park et al .[ 5 ] in 2016 and nine articles were added in this updated meta-analysis.
Study characteristics
All articles were a prospective randomised clinical trial. The studies consisted two or more groups in which control arm is endotracheal intubation and intervention arm is the insertion of either one or more than one type of SAD. This review includes a total of 2213 patients who met our inclusion criteria [Table 2 ].[ 4 , 7–12 , 15–28 ]
Table 2: Summary of studies evaluating the effects of various interventions
Risk of bias assessment
Risk of bias was assessed as per authors’ judgement. Among 21 RCTs, 12 studies demonstrated an overall low risk of bias in most of the categories [Figure 2 ]. Nine studies demonstrated some concerns in RoB 2 tool either due to loss of outcome data or bias in measurement of outcome. Two studies also showed bias in selection of reported results.[ 8 , 19 ]
Figure 2: Risk of bias (RoB 2) plot
Results of individual studies
Primary outcome
Comparison of sore throat and hoarseness
The incidence of sore throat was studied in 18 studies.[ 4 , 7–12 , 18–28 ] Pooled analysis showed 44% reduction in incidence of sore throat in SAD group as compared to ET intubation group (RR 0.44, P < 0.00001 [0.30, 0.65], i 2 = 72%) [Figure 3a ]. However, there was detection bias noted in few studies.[ 11 , 16 , 18 , 28 ]
Figure 3: Forest plot for various airway related complications with supraglottic airway devices and endotracheal intubation
Hoarseness was reported in eight studies.[ 4 , 8–11 , 18 , 21 , 25 ] Analysis of pooled data showed 38% reduction in incidence of hoarseness in SAD group as compared to ET intubation group (RR 0.38, P < 0.01 [0.21, 0.69], i 2 = 72%) [Figure 3b ].
The subgroup analysis of these primary outcomes is shown in Figure 4a and 4b . P value for subgroup differences in sore throat and hoarseness were 0.3 and 0.07, respectively.
Figure 4: Forest plot for subgroup analysis (a) Sore throat (b) Subgroup analysis for hoarseness
Secondary outcome
Vomiting was studied in eight studies, whereas nausea was studied in seven studies. The incidence of nausea was 83% in SAD group as compared to ET intubation group (RR 0.83, P = 0.26 [0.60, 1.15], i 2 = 52%)[ 4 , 7–12 ] [Figure 3c ]. There was no difference between fixed-effect and random-effect models for nausea.
The occurrence of vomiting among the eight studies secured nonsignificant results in random-effect model.[ 4 , 7 , 9–12 , 20 , 22 ] Incidence of vomiting SAD was 60% as compared to tracheal intubation group (RR 0.60, P = 0.13 [0.32, 1.15], i 2 = 14%). In contrast with the random-effect model, the incidence of vomiting when analysed in fixed-effect model yielded significant results. The incidence of vomiting was 55% in SAD group as compared to ET intubation group (RR 0.55, P = 0.03 [0.33, 0.93], i 2 = 14% [Figure 3d ]. Three studies did not report any incidence of vomiting.[ 4 , 7 , 22 ]
The occurrence of stridor was observed in two studies.[ 16 , 17 ] The incidence of stridor was 38% lower in SAD group as compared to tracheal intubation group (RR 0.38, 95% CI [0.13, 1.18], i 2 = 0%) [Figure 3e ]. There is a potential risk of bias as only two studies were included and both were done by the same Maltby et al .[ 16 , 17 ]
There were five studies that contributed to the analysis of cough with SAD or tracheal intubation.[ 15–17 , 20 , 25 ] We observed 11% reduction of cough in SAD group as compared to ET intubation group (RR 0.11, P < 0.00001 [0.06, 0.20], i 2 = 42%) [Figure 3f ]. In our study, three out of five studies were conducted by the same author which may led to bias.
There was high heterogeneity in sore throat and hoarseness groups. We conducted subgroup analysis with different types of supraglottic devices but found very heterogenous results in sore throat group.
DISCUSSION
In our meta-analysis, the occurrences of sore throat, nausea, hoarseness, vomiting, stridor and cough were greater in the ETT group than in the SAD group. The meta-analysis by Park et al .[ 5 ] obtained similar results. There were 17 studies, including paediatric patients where supraglottic devices were compared with endotracheal intubation . We included 12 studies from previous study done by Park et al . and included 9 more studies to analyse airway complications. There were a veriety of SADs, namely LMA Classic, ProSeal LMA, I-Gel, SLIPA, Protector LMA, LMA Supreme and Combitube that was used in different studies and compared with endotracheal intubation . The control arm was designated to endotracheal intubation in all studies. In one study, a specialised endotracheal tube (Profile Soft – seal Cuff™) was used which is included in control arm.[ 9 ] Some studies included two groups in intervention arm, comparing SADs with endotracheal tube, while one study used a specialised endotracheal tube in control arm.[ 11 , 17 , 19 , 27 ]
Sore throat
Sore throat is associated with anatomical regions where high pressure is applied due to cuff insufflation. It has been reported that postoperative sore throat is an inflammatory process since inflammatory mediators were detected in the tracheal mucosa following intubation.[ 29 ] Our results show that the occurrences of ‘sore throat’ postoperatively were greater in the ETT group than in the SAD group. This finding is similar to Yu’s finding, who conducted a meta-analysis in 2010 and concluded that ETT had a higher occurrence of ‘sore throat’ (RR = 1.67, 95% CI = 1.33–2.11) than LMA, although the difference was modest and insignificant.[ 30 ] In our meta-analysis, we found that there is 44% risk reduction but with high heterogeneity. We believed that the use of different types of LMA may be associated with heterogenous result. We conducted subgroup analysis of different types of LMA but did not find any significant difference in heterogeneity. Included studies had uneven sample sizes in two groups which could have caused high heterogeneity[ 11 , 19 , 23 ] [Figure 4a ].
Hoarseness
Our findings suggest that the occurrence of hoarseness of voice was greater in the ETT group than in the SAD group. Tracheal intubation with ETT can cause direct damage to the ‘vocal cords’ because of neck overextension throughout the overinflated cuff or intubation that holds constant pressure on the vocal cords.[ 31 ] SADs induce minimal trauma to the trachea and vocal cords and less pressure damage to the pharynx. SAD cuffs are positioned above the larynx, which means they are less likely to irritate the vocal cords and trachea. Abdi et al .[ 18 ] concluded with significant results favouring SADs in preventing hoarseness. Another study by Ulrich-Pur et al .[ 32 ] showed that many supraglottic airways (except intubating LMA) apply a suitable pressure to keep mucosal perfusion when employing the ‘cuff pressure’ recommended by the manufacturers. Moreover, in laparoscopic surgery after pneumoperitoneum when diaphragm is pushed up, there is an anatomical alteration in the position of carina which gets further irritated by indwelling endotracheal tube.[ 33 ] There was high statistical heterogeneity of 72% in this group. We conducted subgroup analysis with different types of supraglottic devices and found that LMA Classic[ 10 , 25 ] yielded the most consistent result with i 2 of 0%. Other studies with LMA Supreme[ 11 , 18 ] and LMA ProSeal[ 8 , 9 ] yielded i 2 of 49% and 42%, respectively [Figure 4b ].
Nausea and vomiting
The main disadvantage of SAD is that they do not reliably protect the lungs from regurgitated gastric contents and inadequate ventilation.[ 4 ] The higher airway pressure caused by CO2 pneumoperitoneum as well as Trendelenburg’s position will theoretically increase gastric air content. The increase in intra-abdominal pressure causes a reflex rise in the tone of the LES (lower oesophageal sphincter), leading to nausea and regurgitation of gastric content. The increased tone of the LES hampers the vision of the surgical site, thereby making surgery cumbersome and further increasing the occurrence of postoperative nausea and vomiting. In our review, we found that there was a higher incidence of nausea and vomiting in ETT group. In spite of the assumption that SADs have safety issues in preventing regurgitation, no study reported any incidence of aspiration. Moreover, supraglottic devices showed a favourable trend but statistically it was not significant.
Stridor
The most common cause of immediate stridor after surgery is oedema from trauma to the airway.[ 34 ] Only two studies contributed to our analysis, which was not enough to give strong evidence. However, the trend was in favour of SADs as compared to trachea intubation. Airways compromise such as stridor and other life-threatening complications may occur with endotracheal intubation , which can be avoided with the use of SADs.[ 35 ]
Cough
The SAD group (11%) had a substantially lower occurrence of coughing throughout the recovery period as evaluated by the ETT group (89%). Our outcomes validate the findings of previous investigations and systematic analyses.[ 20 , 36 ]
Endotracheal tubes can cause significant undesirable events due to tracheal irritation in the postoperative period . Coughing may cause bleeding at the surgical site, especially for patients undergoing oral maxillofacial surgery, otorhinolaryngology and cardiothoracic surgery, hence increasing the risk of airway blockage and suffocation, leading to oxygen desaturation. It increases the chance of wound dehiscence and internal or external bleeding.[ 37 ]
This updated meta-analysis obtained similar results for airway complications as compared with the previous meta-analysis by Park et al .[ 5 ]
We also performed GRADE analysis[ 38 , 39 ] in this study. We found high certainty evidence in sore throat, hoarseness, vomiting and cough. Nausea and stridor yielded moderate quality of evidence. However, the credibility of evidence is moderate when we performed the test for credibility on instrument for assessing the Credibility of Effect Modification Analyses (ICEMAN) in meta-analyses of randomised controlled trials (Version 1.0)[ 40 ] [Supplementary Table 2 ]. The overall recommendation is in favour for the use of SADs with high certainty but moderate credibility of evidence [Supplementary Figure 3 ].
Our study had some limitation. Firstly, SADs are available in different types. Many studies used different types of SADs. Few studies have uneven distribution of samples in different groups. Approximately, half of the studies were carried out in laparoscopic cholecystectomies while the other half was performed in gynaecological surgeries. There is large variation of position on these types of surgeries which may have impact on heterogenous outcome.
Secondly, the possibility of publication bias derived from studies that are not published in the current literature because of null results or small sample sizes cannot be denied. On the basis of results of Begg funnel plot and Egger test to detect publication bias, we can conclude that more studies are required to minimise publication bias. Our study meticulously examined the present literature to compare SADs and ETTs in patients undergoing laparoscopic surgery and updated the existing evidence. Supraglottic devices are very safe and effective in airway management in laparoscopic surgery under general anaesthesia.
CONCLUSION
In conclusion, we observed a substantial variation between SADs and ETTs with respect to the occurrence of hoarseness, sore throat, cough and nausea. However, the occurrences of vomiting and stridor were greater in the ETT group than SAD group, but we needed more data to reach a significant conclusion. These findings indicate that compared with ETTs, SADs induce lesser trauma on the vocal cords and trachea, and lesser pressure damage to the pharynx. The anatomical changes in upper airway due to pneumoperitoneum further aggravate the damage caused by endotracheal tube. Because the cuffs of SGAs are placed superior to the larynx, they cause less irritation to the vocal cords and trachea, thereby reducing adverse effects.
Thus, we can conclude that SADs can be clinically valuable and safe airway adjuncts to prevent airway complications during laparoscopic surgery.
Financial support and sponsorship
Authors have not received any financial support or sponsorship.
Conflicts of interest
There are no conflicts of interest.
Acknowledgments
We are deeply thankful to our linguistic expert Mr. Prakash M. Singh for his expert advice and unconditional support.
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