Pediatric supraglottic airway devices in clinical practice: A prospective observational study.
ABSTRACT: Supraglottic airway devices (SGA) are commonly used in pediatric anesthesia and serve as primary or back-up devices for difficult airway management. Most SGA are marketed without proper clinical evaluation. The purpose of this study was to evaluate the performance of the pediatric LMA Supreme™, Air-Q® and Ambu® Aura-i™.This prospective observational study was performed at Bern University Hospital, Switzerland. With ethics committee approval and a waiver for written informed consent 240 children undergoing elective surgery with an ASA class I-III and a weight of 5-30 kg were included. Three different pediatric supraglottic airway devices were assessed: The LMA Supreme™, Air-Q® and Ambu® Aura-i™. Primary outcome parameter was airway leak pressure. Secondary outcome parameters included first attempt and overall success rate, insertion time, fiberoptic view through the SGA, and adverse events. The primary hypothesis was that the mean airway leak pressure of each tested SGA was 20 cmH2O ± 10%.None of the SGA showed a mean airway leak pressure of 20 cmH2O ± 10%, but mean airway leak pressures differed significantly between devices [LMA Supreme™ 18.0 (3.4) cmH2O, Air-Q® 15.9 (3.2) cmH2O, Ambu® Aura-i™ 17.3 (3.7) cmH2O, p < 0.001]. First attempt success rates (LMA Supreme™ 100%, Air-Q® 90%, Ambu® Aura-i™ 91%, p = 0.02) and overall success rates (LMA Supreme™ 100%, Air-Q® 91%, Ambu® Aura-i™ 95%, p = 0.02) also differed significantly. Insertion times ranged from 20 (7) seconds (Air-Q®) to 24 (6) seconds (LMA Supreme™,
Project description:Introduction:During esophagogastroduodenoscopy (EGD), general anesthesia (GA) may be provided using a laryngeal mask airway (LMA) with the endoscope inserted behind the cuff of the LMA into the esophagus. Passage of the endoscope may increase the intracuff of the LMA. We evaluated a newly designed LMA (LMA® Gastro™ Airway) which has an internal channel exiting from its distal end to facilitate EGD. The current study compared the change of LMA cuff pressure between this new LMA and a standard clinical LMA (Ambu® AuraOnce™) during EGD. Methods:Patients less than 21 years of age and weighing more than 30 kg were randomized to receive airway management with one of the two LMAs during EGD. After anesthetic induction and successful LMA placement, the intracuff pressure of the LMAs was continuously monitored during the procedure. The primary outcome was the change of intracuff pressure of the LMAs. Results:The study cohort included 200 patients (mean age 13.6 years and weight 56.6 kg) who were randomized to the LMA® Gastro™ Airway (n=100) or the Ambu® AuraOnce™ LMA (n=100). Average intracuff pressures during the study period (before and after endoscope insertion) were not different between the two LMAs. Ease of the procedure was slightly improved with the LMA® Gastro™ Airway (p<0.001). Discussion:The LMA® Gastro™ Airway blunted, but did not prevent an increase in intracuff pressure during EGD when compared to the Ambu® AuraOnce™ LMA. Throat soreness was generally low, and complications were infrequent in both groups. The ease of the procedure was slightly improved with the LMA® Gastro™ Airway compared to the Ambu® AuraOnce™ LMA.
Project description:Background:When managing patients with a difficult airway, supraglottic airways (SGAs) have been used as rescue devices or to serve as a conduit for endotracheal intubation. The current study compares various clinical outcomes, including the bronchoscopic view of the glottis when using 2 SGAs, the Air-Q® laryngeal mask airway (LMA) and the i-gel® SGA, in pediatric patients. Methods:Patients ?18 years of age were prospectively randomized to receive either the Air-Q® LMA or the i-gel® SGA. Following SGA placement, a flexible fiberoptic bronchoscope was inserted through the SGA to visualize the glottis. Time taken to obtain the bronchoscopic view and place the SGA, and the ability to seal the airway at 20 cmH2O were compared. The bronchoscopic view obtained was graded as follows: 1) glottic aperture seen completely; 2) glottic aperture seen partially with visual obstruction <50%; 3) glottic aperture seen, but visual obstruction >50%; and 4) glottic aperture not seen. Results:Fifty patients were enrolled and 48 (22/26 male/female) were included in the analysis. Median age was 13 years (IQR: 7, 16) and median weight was 49 kg (IQR: 25, 70). The Air-Q® LMA and i-gel® SGA groups did not differ in device placement time (median of 19 vs 21 seconds; 95% CI of difference in medians: - 2 to 7; P=0.331), the time to achieve fiberoptic view of the glottis (median of 25 vs 21 seconds; 95% CI of difference: - 9 to 8; P=0.489) or the grade of the bronchoscopic view of the airway. Eight Air-Q® and 6 i-gel® supraglottic devices sealed the airway at 20 cmH2O. Discussion:The time required for successful placement of the SGA, the time required for bronchoscopic view, and the quality of bronchoscopic view through the Air-Q® LMA and the i-gel® SGA did not differ.
Project description:<h4>Background and aims</h4>The Laryngeal Mask Airway (LMA) Protector™ is one of the latest introduced supraglottic airway devices. It provides access and functional separation of the respiratory and digestive tracts. Compared to the LMA Supreme™, it has two digestive ports, one to provide suction in the pharyngeal region and one for gastric tube insertion. High oropharyngeal leak pressure is a marker for safe ventilation when using LMA devices. We hypothesized that oropharyngeal leak pressure of the LMA Protector™ is 5 cm H<sub>2</sub>O higher than the oropharyngeal leak pressure of the LMA Supreme™ at various cuff volumes. Secondary outcome measures were ease of insertion of both masks, fiberoptic confirmation of correct positioning, failures of insertion, presence of blood staining, sore throat, presence of air leak and insertion time.<h4>Material and methods</h4>American Society of Anesthesiologists (ASA) I-III patients aged >18 years, scheduled for elective minor ambulatory surgery under general anesthesia with a LMA were included. Patients were randomized in the LMA Protector™ or LMA Supreme™ group based on a computer-generated random sequence table. After general anesthesia induction, oropharyngeal leak pressures were measured.<h4>Results</h4>Oropharyngeal leak pressures were significantly higher (<i>P</i> < 0.0001) for LMA Protector™ compared to LMA Supreme™ at different cuff volumes and a cuff pressure of 65 cm H<sub>2</sub>O. Insertion time was significantly higher for the LMA Protector™ (29 sec) [interquartile range (IQR) 23, 35] compared to the LMA Supreme™ (19 sec) (IQR 16, 22) (<i>P</i> < 0.0001). There were no statistically significant differences in ease of insertion (number of attempts for succesful positioning), failures of insertion, presence of blood staining, sore throat or presence of air leak.<h4>Conclusion</h4>Oropharyngeal leak pressures were consistently higher (>5 cm H<sub>2</sub>O) for LMA Protector™ compared to LMA Supreme™. LMA Protector™, therefore, allows effective ventilation at higher airway pressures than LMA Supreme™.<h4>Trial registration</h4>http://clinicaltrials.gov.NCT03462550.
Project description:BACKGROUND:The intubating laryngeal mask Fastrach™ is considered a gold standard for blind intubation as well as for fibreoptic guided intubation via a laryngeal mask. Recently, a single use version of the mask has been introduced. We compared the Fastrach single use with the new, low-priced single use intubating laryngeal mask Ambu Aura-i™. We hypothesised that the LMA Ambu Aura-i and the LMA Fastrach are comparable with respect to success rates for mask placement and blind tracheal intubation through the LMA device. METHODS:A prospective, randomised clinical trial. University Hospital Schleswig-Holstein, Campus Kiel, from April 2011 to April 2012. Eighty patients undergoing general anaesthesia with planned tracheal intubation were randomised and enrolled in the study. Blind intubation was performed with either laryngeal mask using two different tracheal tubes (Rüsch Super Safety Silk™ and LMA ETT™). A crossover-design was performed after an unsuccessful procedure. Primary outcome measure was the overall success rate of blind intubation. Secondary outcome measures were the time to the first adequate ventilation, a subjective handling score, and a fibreoptic control of placement, as well as the success rate of mask placement, time for mask removal after successful intubation, differences in airway leak pressure, and the incidence of postoperative sore throat and hoarseness. RESULTS:The success rate of tracheal intubation with the Fastrach for the first and second attempt was significantly better compared with the Ambu Aura-i. Tracheal intubation was also significantly faster (14.1?s. ±4.4 versus 21.3?s. ±9.0; p <?0.01), and the time interval for mask removal after successful intubation was significantly shorter using the Fastrach device (24.0?s. ±8.2 versus 29.4?s. ±7.5; p <?0.001). There were no significant differences between groups regarding the incidence of postoperative sore throat and hoarseness. CONCLUSION:Both laryngeal mask devices are suitable for ventilation and oxygenation. Blind intubation remains the domain of the LMA Fastrach, the Ambu Aura-i is not suitable for blind intubation. TRIAL REGISTRATION:Clinicaltrials.gov Identification Number NCT03109678 , retrospectively registered on April 12, 2017.
Project description:We aimed to compare the effectiveness of supraglottic airway devices as a strategy for unassisted tracheal intubation. Accordingly, we searched the OVID-MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, KoreaMed, and Google Scholar databases to identify all relevant randomized controlled trials (RCTs) on supraglottic airway devices as a strategy for tracheal intubation published until May 2017. The primary outcome was the overall success rate of intubation by the intention to treat (ITT) strategy. The secondary outcomes of the study were the overall success rate of tracheal intubation by the per protocol (PP) strategy and the success rate of tracheal intubation at first attempt by ITT and PP. We conducted a network meta-analysis with a mixed-treatment comparison method to combine direct and indirect comparisons among supraglottic airway devices. Of 1396 identified references, 16 RCTs (2014 patients) evaluated unassisted intubation with supraglottic airway devices. Patients were grouped according to the type of device used: LMA-CTrach, LMA-Fastrach, Air-Q, i-gel, CobraPLA, Ambu-Aura, or single-use LMA devices. Based on the surface under the cumulative ranking curve, the three best supraglottic airway devices for use as a strategy for unassisted tracheal intubation were LMA-CTrach (which included video-assisted tracheal tube guidance), single-use LMA-Fastrach, and LMA-Fastrach. LMA-Fastrach showed a higher success rate of intubation than did i-gel, CobraPLA, Air-Q, and Ambu-Aura. However, this study was limited by the small number of eligible RCTs. Therefore, well-designed RCTs performed on large patient populations are required to increase the confidence of the results.
Project description:BACKGROUND:In the present study, we compare the LMA-Protector™ and the i-gel™ in terms of adequacy of the airway seal, insertion time, ease and accuracy of insertion, and the incidence of postoperative sore throat. METHODS:In 110 anesthetized and paralyzed adult patients, the i-gel™ (n?=?55) or the LMA-Protector™ (n?=?55) was inserted. The primary outcome was airway leak pressure. The secondary outcomes included the first-attempt success rate, insertion time, ease and accuracy of the device insertion, ease of gastric tube placement, blood staining on the device after removal, and incidence and severity of postoperative sore throat. RESULTS:The airway leak pressure was higher with the LMA-Protector™ than with the i-gel™ (31  cmH2O vs. 27  cmH2O, respectively; P?=?0.016). Insertion time was longer with the LMA-Protector™ than with the i-gel™ (27  sec vs. 19  sec, respectively, P?<?0.001), but ease of insertion and the first-attempt success rate were not different between the two groups. The LMA-Protector™ provided a worse fiberoptic view of the vocal cords and more difficult gastric tube insertion than the i-gel™ (both P?<?0.001). Blood staining on the device was more frequent with the LMA-Protector™ than with the i-gel™ (P?=?0.033). The incidence and severity of postoperative sore throat were not different between the two groups. CONCLUSION:The LMA-Protector™ provided a better airway sealing effect than the i-gel™. However, it required a longer insertion time, provided a worse fiberoptic view of the vocal cords, and caused more mucosal injury compared to the i-gel™. TRIAL REGISTRATION:ClinicalTrials.gov (NCT03078517). Registered prior to patient enrollment, Date of registration: Mar 13, 2017.
Project description:The Guardian Laryngeal Mask Airway (G-LMA) is a new silicone-based single-use extraglottic device with the drainage port and a cuff pilot valve with pressure indicator. The aim of this study is to compare the clinical performance of this laryngeal mask airway with ProSeal laryngeal mask airway (P-LMA).In this prospective randomized study, we included adult patients with ASA grading I and II scheduled for elective surgery requiring supine position under total intravenous anesthesia. The patients were randomly allocated to two groups, 40 in each. G-LMA and P-LMA were used in groups G and P respectively. The cuff of each device was air inflated to 60 cmH2O. The primary outcome was to compare the airway sealing pressure and the secondary outcome was to compare the efficacy and safety of these two devices with respect to insertion success, insertion time, ease of insertion, volume of air for cuff inflation to 60 cmH2O, intracuff pressure measurement, gastric tube insertion attempt, gastric tube insertion time, Fiberoptic laryngeal view, and postoperative pharyngolaryngeal morbidity.The airway sealing pressure at 60 cmH2O cuff pressure was significantly greater in G-LMA than P-LMA (p?=?0.04).The first successful attempt of both groups were comparable (p?=?1.000). Insertion time was significantly shorter in G-LMA than P-LMA (p?<?0.0001). The first successful attempt for the gastric tube insertion in both groups was comparable (p?=?0.431). Gastric tube insertion time was less in G-LMA than in P-LMA (p?<?0.0001). The volume of air for cuff inflation to 60 cmH2O was more in G-LMA than in P-LMA (<0.0001). The intracuff pressure measurement at 30, 60, 90 and 120 minutes were comparable (p?=?0.823, 0.182, 0.870, 0.658).We did not find differences in ease of insertion (p?=?0.60); Fiber-optic positions of airway devices were comparable (p?=?0.83). In addition, blood staining (p?=?1.00), sore throat and dysphagia at 1, 2 and 24 hour (p?=?1.00) were comparable in both groups.The Guardian laryngeal mask airway was associated with high airway sealing pressure with a quicker insertion of the device as well as gastric tube.Clinical Trial.gov Identifier: NCT02063516. Date: June 2013.
Project description:A new supraglottic device, the LMA-Supreme™, has recently become available for clinical use. Information on anaesthetic and co-adjuvant requirements for insertion of the LMA-Supreme™ is limited. The present study aimed to evaluate the optimal effect-site concentration of propofol in 50 % (EC50) of adults necessary for successful insertion of the LMA-Supreme™ and to examine remifentanil's effect on propofol requirements.Fifty-eight elective patients (aged 18-60 years; ASA (American Society Anaesthesiologists) physical status classification I and II) scheduled for day surgery were randomly assigned to one of two groups: propofol with saline or propofol with remifentanil. Anaesthesia was induced by target-controlled infusion according to predetermined effect-site concentrations of propofol and remifentanil (5 ng.mL(-1)). The EC50 was calculated using Dixon's up-and-down method. Ten minutes following drug administration, LMA-Supreme™ insertion was attempted without the use of muscle relaxant drugs.In the propofol + saline group, the EC50 of propofol required for LMA-Supreme™ insertion was 6.32 ± 0.67 ?g.mL(-1) (95 % CI, 5.69-6.94 ?g.mL(-1)). With the addition of remifentanil at an effect-site concentration of 5 ng.mL(-1), the EC50 of propofol required for LMA-Supreme™ insertion was 2.50 ± 0.80 ?g.mL(-1) (95 % CI, 1.82-3.17 ?g.mL(-1); p < 0.0001).The propofol requirement for smooth insertion of the LMA-Supreme™ was 60 % less when remifentanil (5 ng.mL(-1)) was co-administered.Identified as NCT01974648 at www.clinicaltrials.gov .
Project description:<h4>Background and objective</h4>Conflicting results were found between the I-gel™ and the LMA-Supreme™ during anesthesia, so we conducted a meta-analysis of randomized controlled trials (RCTs) to compare the effectiveness and safety of the I-gel™ vs. the LMA-Supreme™during anesthesia.<h4>Methods</h4>A comprehensive search was conducted using Pubmed, EMbase, ISI Web of Knowledge, the Cochrane Library, China Journal Full-text Database, Chinese Biomedical Database, Chinese Scientific Journals Full-text Database, CMA Digital Periodicals, and Google scholar to find RCTs that compare the LMA-S™ with the i-gel™during anesthesia. Two reviewers independently selected trials, extracted data, and assessed the methodological qualities and evidence levels. Data were analyzed by RevMan 5.0 and comprehensive meta-analysis software.<h4>Results</h4>Ten RCTs were included. There were no significant differences in oropharyngeal leak pressures (mean difference [MD] 0.72, 95% confidence interval [CI] -1.10 2.53), device placement time (MD -1.3, 95%CI -4.07 1.44), first attempt insertion success (risk ratio [RR] 1.01, 95% CI 0.9 1.14), grade 3 and 4 fiberoptic view (RR 0.89, 95%CI 0.65 1.21), and blood on removal (RR 0.62, 95%CI 0.32 1.22) between the i-gel™ and the LMA-Supreme™, respectively. However, the LMA-Supreme™was associated with easier gastric tube insertion (RR 1.17, 95%CI 1.07 1.29), and more sore throat (RR 2.56, 95%CI 1.60 4.12) than the i-gel™ group.<h4>Conclusions</h4>The LMA-Supreme™ and i-gel™ were similarly successful and rapidly inserted. However, the LMA-Supreme™ was shown to be easier for gastric tube insertion and associated with more sore throat compared with the i-gel™.
Project description:The LMA Protector™ is the latest CE marked single use supraglottic airway device. This airway device provides access and functional separation of the respiratory and digestive tracts. There are two ports (male, female ports) to provide suction in the laryngeal region and insertion of the gastric tube. The aim of our study is to assess the ease of use, airway quality, device positioning, airway leak and complications associated with initial clinical experience in LMA Protector™ usage.This is an initial investigation of LMA Protector™ airway device. We conducted a preliminary assessment in the anaesthetised women who underwent minor gynaecological procedures with spontaneous ventilation in order to evaluate the performance of the airway device.Insertion was successful on first and second attempts in 23 (88.5%) and 3 (11.5%) respectively. Median [IQR (range)] insertion time was 19 [17-21(14-58)] seconds. Airway leak pressure was 25.5 [23-29(21-30] cmH2O. On fibreoptic examination via the device, vocal cords were visible in all 26 patients. There were no alternative airway use or airway manipulations required during maintenance of anaesthesia. Six patients had sore throat 24 h after procedures and there was no dysphagia or hoarseness.This pilot study of the LMA protector shows that the device is easily inserted with fast insertion time, providing a reliable and adequate airway seal.Clinicaltrials.gov Registration NCT02531256 . Retrospectively registered on August 21, 2015.