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A randomised controlled trial comparing ProSeal laryngeal mask airway, i-gel and Laryngeal Tube Suction-D under general anaesthesia for elective surgical patients requiring controlled ventilation.

ABSTRACT: Background and Aims:The ProSeal™ laryngeal mask airway (PLMA), i-gel™ and Laryngeal Tube Suction-D (LTS-D™) have previously been evaluated alone or in pair-wise comparisons but differing study designs make it difficult to compare the results. The aim of this study was to compare the clinical performance of these three devices in terms of efficacy and safety in patients receiving mechanical ventilation during elective surgical procedures. Methods:This prospective, randomised, double-blind study was conducted on 150 American Society of Anesthesiologists physical status I-II patients, randomly allocated into 3 groups, undergoing elective surgical procedures under general anaesthesia. PLMA, i-gel™ or LTS-D™ appropriate for weight or/and height was inserted. Primary outcome measured was airway sealing pressure. Insertion time, ease of insertion, number of attempts, overall success rate and the incidence of airway trauma and complications were also recorded. Intergroup differences were compared using one-way analysis of variance with post hoc correction for continuous data and Chi-square test for categorical variables. Results:Overall success rate was comparable between the three devices (i-gel™ 100%, LTS-D™ 94%, PLMA 96%). Airway sealing pressure was lower with i-gel™ (23.38 ± 2.06 cm H2O) compared to LTS-D™ (26.06 ± 2.11 cm H2O) and PLMA (28.5 ± 2.8 cm H2O; P < 0.0005). The mean insertion time was significantly more in PLMA (38.77 ± 3.2 s) compared to i-gel™ (27.9 ± 2.53 s) and LTS-D™ (21.66 ± 2.31 s; P < 0.0005). Conclusion:Airway sealing pressure and insertion time were significantly higher in PLMA compared to i-gel™ and LTS-D™.

SUBMITTER: Das B

PROVIDER: S-EPMC5752783 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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A randomised controlled trial comparing ProSeal laryngeal mask airway, i-gel and Laryngeal Tube Suction-D under general anaesthesia for elective surgical patients requiring controlled ventilation.

Das Bikramjit B Varshney Rahul R Mitra Subhro S

Indian journal of anaesthesia 20171201 12

<h4>Background and aims</h4>The ProSeal™ laryngeal mask airway (PLMA), i-gel™ and Laryngeal Tube Suction-D (LTS-D™) have previously been evaluated alone or in pair-wise comparisons but differing study designs make it difficult to compare the results. The aim of this study was to compare the clinical performance of these three devices in terms of efficacy and safety in patients receiving mechanical ventilation during elective surgical procedures.<h4>Methods</h4>This prospective, randomised, doubl ...[more]

PMID: 29307902

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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:BackgroundProSeal (PLMA) and Supreme (SLMA) laryngeal mask airways are effective ventilator devices with distinctive designs that may require different anaesthetics for insertion. Sevoflurane induction provides acceptable conditions for laryngeal mask insertion, and remifentanil significantly decreases the minimum alveolar concentration of sevoflurane required for that insertion. The study aimed to evaluate the optimal end-tidal (ET) sevoflurane concentration for successful insertion of PLMA versus SLMA in patients receiving a remifentanil infusion without a neuromuscular blocking agent.MethodsAltogether, 45 patients ASA (American Society Anaesthesiologists) physical status I-II, aged 18-60 years were scheduled for elective ambulatory surgery. Exclusion criteria were a difficult airway, recent respiratory infection, reactive airway, obstructive sleep apnoea syndrome, gastric aspiration's risk factors, pregnancy, and lactation. Patients were randomly allocated to receive the SLMA or the PLMA. Sevoflurane induction with co-administration of remifentanil was performed at an effect-site concentration of 4 ng mL- 1. ET50 was calculated with a modified Dixon's up-and-down method (starting at 2.5% in steps of 0.5%). Predetermined sevoflurane concentration was kept constant during the 10 min before LMA insertion. Patient's response to LMA insertion was classified as "movement" or "no movement". Sevoflurane ET50 was determined as the midpoint concentration of all the independent pairs that manifested crossover from "movement" to "no movement".ResultsThe ET50 sevoflurane concentration co-administered with remifentanil required for PLMA insertion was 1.20 ± 0.41% (95% confidence interval 0.76 to 1.63%). For SLMA insertion, it was 0.55 ± 0.38% (95% confidence interval 0.14 to 0.95%) (p = 0.019).ConclusionsThe end-tidal sevoflurane concentration with co-administered remifentanil required to allow insertion of the SLMA was 54% lower than that needed for inserting the PLMA.Trial registrationClinicaltrials.gov identifier: NCT03003377. Retrospectively registered. Date of registration: December 28, 2016.

Project description:The Laryngeal Tube Suction Disposable (LTS-D) and the Supreme Laryngeal Mask Airway (SLMA) are second generation supraglottic airway devices (SADs) with an added channel to allow gastric drainage. We studied the efficacy of these devices when using pressure controlled mechanical ventilation during general anesthesia for short and medium duration surgical procedures and compared the oropharyngeal seal pressure in different head and-neck positions.Eighty patients in each group had either LTS-D or SLMA for airway management. The patients were recruited in two different institutions. Primary outcome variables were the oropharyngeal seal pressures in neutral, flexion, extension, right and left head-neck position. Secondary outcome variables were time to achieve an effective airway, ease of insertion, number of attempts, maneuvers necessary during insertion, ventilatory parameters, success of gastric tube insertion and incidence of complications.The oropharyngeal seal pressure achieved with the LTS-D was higher than the SLMA in, (extension (p=0.0150) and right position (p=0.0268?? at 60 cm H2O intracuff pressures and nearly significant in neutral position (p?=?0.0571). The oropharyngeal seal pressure was significantly higher with the LTS-D during neck extension as compared to SLMA (p=?0.015). Similar oropharyngeal seal pressures were detected in all other positions with each device. The secondary outcomes were comparable between both groups. Patients ventilated with LTS-D had higher incidence of sore throat (p?=?0.527). No major complications occurred.Better oropharyngeal seal pressure was achieved with the LTS-D in head-neck right and extension positions , although it did not appear to have significance in alteration of management using pressure control mechanical ventilation in neutral position. The fiberoptic view was better with the SLMA. The post-operative sore throat incidence was higher in the LTS-D.ClinicalTrials.gov ID: NCT02856672 , Unique Protocol ID:BnaiZionMC-16-LG-001, Registered: August 2016.

Dataset Information

A randomised controlled trial comparing ProSeal laryngeal mask airway, i-gel and Laryngeal Tube Suction-D under general anaesthesia for elective surgical patients requiring controlled ventilation.

Publications

A randomised controlled trial comparing ProSeal laryngeal mask airway, i-gel and Laryngeal Tube Suction-D under general anaesthesia for elective surgical patients requiring controlled ventilation.

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