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A randomized prospective controlled trial comparing the laryngeal tube suction disposable and the supreme laryngeal mask airway: the influence of head and neck position on oropharyngeal seal pressure.

ABSTRACT: 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.

SUBMITTER: Somri M

PROVIDER: S-EPMC5054611 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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A randomized prospective controlled trial comparing the laryngeal tube suction disposable and the supreme laryngeal mask airway: the influence of head and neck position on oropharyngeal seal pressure.

Somri Mostafa M Vaida Sonia S Garcia Fornari Gustavo G Mendoza Gabriela Renee GR Charco-Mora Pedro P Hawash Naser N Matter Ibrahim I Swaid Forat F Gaitini Luis L

BMC anesthesiology 20161006 1

<h4>Background</h4>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.<h4>Methods</h4>Eighty patients ...[more]

PMID: 27716165

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Project description:Background and aimsThe 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 H2O 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.Material and methodsAmerican 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.ResultsOropharyngeal leak pressures were significantly higher (P < 0.0001) for LMA Protector™ compared to LMA Supreme™ at different cuff volumes and a cuff pressure of 65 cm H2O. 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) (P < 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.ConclusionOropharyngeal leak pressures were consistently higher (>5 cm H2O) for LMA Protector™ compared to LMA Supreme™. LMA Protector™, therefore, allows effective ventilation at higher airway pressures than LMA Supreme™.Trial registrationhttp://clinicaltrials.gov.NCT03462550.

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:BACKGROUND:Obstetric dfficult airway is a leading cause of maternal morbidity and mortality. The laryngeal mask airway (LMA) is often used as a rescue airway device after failed intubation, however, little is known about predictors of difficult LMA insertion, particularly in obstetrics. Since Mallampati scores of III/IV has been associated with difficult tracheal intubation, our present study aims to investigate if Mallampati score (MP) could predict airway outcomes for LMA use in obstetrics. METHODS:This prospective cohort study was performed at a single-center: Quanzhou Women's and Children's Hospital, Fujian Province, China. Five hundred and eighty-four parturients undergoing elective cesarean section under general anesthesia were recruited. The primary outcome was time to effective ventilation, and secondary outcomes included first attempt insertion success, seal pressure, ventilation and hemodynamic parameters, occurrence of clinical aspiration, and maternal and fetal outcomes. RESULTS:The parturients were classified into two groups based on MP of III/IV (High MP: 61) versus I/II (Low MP: 523). BMI was higher in the High MP group than in the Low MP group (mean (SD) 29.3 (7.0) vs 26.8 (3.1), p?<? 0.0001). There was no difference in maternal age, ASA status and gestational age. There was similar time to effective ventilation (mean (SD) High MP: 14.9 (4.5) vs Low MP: 15.7 (4.4) seconds, p?=?0.2172), and first attempt success rate, seal pressure, and peak airway pressure. No clinical aspiration was noted. The incidence of blood on SLMA was higher in the High MP group than in Low MP (4 (6.6%) vs 4 (0.8%), p?=?0.001). There was no difference in sore throat, voice hoarseness, maternal satisfaction and fetal outcomes. CONCLUSION:High MP was not associated with reduced SLMA airway outcomes in cesarean section under general anesthesia, but may increase the risk of blood found on SLMA upon removal. TRIAL REGISTRATION:This study was registered at http://www.clinicaltrials.gov , identifier: NCT02026882 , retrospectively registered. Date of registration: December 31, 2013.

Project description:BACKGROUND:The obstetric airway is a significant cause of maternal morbidity and mortality. Endotracheal intubation is considered the standard of care but the laryngeal mask airway (LMA) has gained acceptance as a rescue airway and has been incorporated into the obstetric airway management guidelines. In this randomized controlled equivalence trial, we compared the Supreme LMA (SLMA) with endotracheal intubation (ETT) in managing the obstetric airway during cesarean section. METHODS:Parturients who underwent elective cesarean section under general anesthesia were randomized to receive either an SLMA or ETT as their airway device. Our primary outcome was first-attempt insertion success. Successful insertion was defined as adequate bilateral air entry with auscultation and the presence of end-tidal carbon dioxide on the capnogram. The first-attempt insertion success rate was compared using the Chi-Square test. Secondary outcomes included time-to-ventilation, seal pressure, ventilation/hemodynamic parameters, occurrence of clinical aspiration, fetal outcomes, and maternal side effects associated with the airway device. RESULTS:We recruited 920 parturients (460 SLMA, 460 ETT) who underwent elective cesarean section under general anesthesia. Patient characteristics were similar between the groups. First attempt success was similar (Odds Ratio--ORSLMA/ETT: 1.00 (95%CI: 0.25, 4.02), p?=?1.0000). SLMA was associated with reduced time to effective ventilation (Mean Difference--MD -22.96; 95%CI: -?23.71, -?22.21?s) compared to ETT group (p?<? 0.0001). Ventilation parameters, maternal and fetal outcomes were similar between the groups, and there was no aspiration. CONCLUSIONS:SLMA could be an alternative airway management technique for a carefully selected low-risk obstetric population, with similar insertion success rates, reduced time to ventilation and less hemodynamic changes compared with ETT. Our findings are consistent with the airway guidelines in recommending the second-line use of LMA in the management of the obstetric airway. TRIAL REGISTRATION:The study was registered at http://www.clinicaltrials.gov , identifier: NCT01858467 , retrospectively registered. Date of registration: May 21, 2013.

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.

Dataset Information

A randomized prospective controlled trial comparing the laryngeal tube suction disposable and the supreme laryngeal mask airway: the influence of head and neck position on oropharyngeal seal pressure.

Publications

A randomized prospective controlled trial comparing the laryngeal tube suction disposable and the supreme laryngeal mask airway: the influence of head and neck position on oropharyngeal seal pressure.

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