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Comparison of the clinical performance of the flexible laryngeal mask airway in pediatric patients under general anesthesia with or without a muscle relaxant: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:The insertion of a laryngeal mask airway (LMA) is difficult in children due to the unique features of their airways. Muscle relaxants have been reported to facilitate LMA insertion in adults; however, there is a lack of evidence supporting this in children. This trial is designed to assess the feasibility of LMA insertion with and without the use of muscle relaxants in pediatric patients under general anesthesia. METHODS/DESIGN:This is a prospective, double-blind, single-center, parallel-arm, non-inferiority, randomized controlled trial to be conducted with participants aged 2-7?years who are undergoing elective ophthalmic surgery under general anesthesia. Participants are randomly assigned to one of two groups based on whether muscle relaxants are used (MR group, n?=?64) or not used (Saline group, n?=?64) prior to LMA insertion. The primary outcome is the oropharyngeal leak pressure (OLP) at a fixed gas flow of 3?L/min. The secondary outcomes are intubation time for successful insertion, ease of insertion and mask bagging, intubation attempt for successful insertion, successful insertion rate on the first attempt, fiberoptic view of the LMA position, postoperative complications, and changes in hemodynamic and ventilatory parameters. DISCUSSION:We will compare the OLPs to determine whether the muscle relaxant provides better conditions for the manipulation of the LMA. This is the first randomized controlled trial to investigate whether muscle relaxants are beneficial to the clinical performance of LMA insertion in pediatric patients under general anesthesia. This trial will be a resource for improving the process and safety of pediatric LMA insertion under general anesthesia. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03487003 . Registered on 18 April 2018.

SUBMITTER: Byun SH

PROVIDER: S-EPMC6325664 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Comparison of the clinical performance of the flexible laryngeal mask airway in pediatric patients under general anesthesia with or without a muscle relaxant: study protocol for a randomized controlled trial.

Byun Sung Hye SH Kim Soo Jin SJ Kim Eugene E

Trials 20190109 1

<h4>Background</h4>The insertion of a laryngeal mask airway (LMA) is difficult in children due to the unique features of their airways. Muscle relaxants have been reported to facilitate LMA insertion in adults; however, there is a lack of evidence supporting this in children. This trial is designed to assess the feasibility of LMA insertion with and without the use of muscle relaxants in pediatric patients under general anesthesia.<h4>Methods/design</h4>This is a prospective, double-blind, singl ...[more]

PMID: 30626406

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Project description:BackgroundThe use of a laryngeal mask airway (LMA) in appropriate patients supports fast-track anesthesia with a lower incidence of postoperative airway-connected adverse events. Data on the most favorable anesthetic in this context, with the lowest rate of upper airway complications and fast emergence times, are controversial and limited. Desflurane seems to match these criteria best, but large randomized controlled trials (RCTs) with a standardized study protocol are lacking. Therefore, we aim to compare desflurane with other commonly used anesthetics, sevoflurane and propofol, in a sufficiently powered RCT. We hypothesize that desflurane is noninferior regarding the frequency of upper airway events and superior regarding the emergence times to sevoflurane and propofol.Methods/designA total of 351 patients undergoing surgery with an LMA will be included in this prospective, randomized, double-blind controlled, multicenter clinical trial. The patients will be randomly assigned to the three treatment arms: desflurane (n = 117), sevoflurane (n = 117), and propofol (n = 117). The emergence time (time to state the date of birth) will be the primary endpoint of this study. The secondary endpoints include further emergence times, such as time to open eyes, to remove LMA, to respond to command and to state name. Additionally, we will determine the frequency of cough and laryngospasm, measured intraoperatively and at emergence. We will assess the postoperative recovery on the first postoperative day via the Postoperative Quality Recovery Scale.DiscussionDespite increasing importance of cost-effective and safe anesthesia application, we lack proof for the most advantageous anesthetic agent, when an LMA is used. There are only a few RCTs comparing desflurane to other commonly used anesthetics (sevoflurane, propofol and isoflurane) in patients with LMA. These RCTs were conducted with small sample sizes, huge interstudy variability, and some also showed strong biases. The present multicenter RCT will provide results from a large sample size with a standardized study protocol and minimized bias, which is feasible in the clinical routine. Furthermore, we will expand our knowledge regarding the most favorable recovery on the first postoperative day, which impacts patients' comfort after surgery.Trial registrationEudraCT Identifier: 2014-003810-96, 5 September 2014 ClinicalTrials.gov: NCT02322502, December 2014.

Project description:ObjectiveFlexible laryngeal mask airways (FLMAs) have been widely used in thyroidectomy as well as cleft palate, nasal, upper chest, head and neck oncoplastic surgeries. This systematic review aims to compare the incidence of airway complications that occur during and after general anesthesia when using the FLMA and endotracheal intubation (ETT). We performed a quantitative meta-analysis of the results of randomized trials.MethodsA comprehensive search of the PubMed, Embase and Cochrane Library databases was conducted using the key words "flexible laryngeal mask airway" and "endotracheal intubation". Only prospective randomized controlled trials (RCTs) that compared the FLMA and ETT were included. The relative risks (RRs) and the corresponding 95% confidence intervals (95% CIs) were calculated using a quality effects model in MetaXL 1.3 software to analyze the outcome data.ResultsTen RCTs were included in this meta-analysis. There were no significant differences between the FLMA and ETT groups in the incidence of difficulty in positioning the airway [RR = 1.75, 95% CI = (0.70-4.40)]; the occurrence of sore throat at one hour and 24 hours postoperative [RR = 0.90, 95% CI = (0.13-6.18) and RR = 0.95, 95% CI = (0.81-1.13), respectively]; laryngospasms [RR = 0.58, 95% CI = (0.27-1.23)]; airway displacement [RR = 2.88, 95% CI = (0.58-14.33)]; aspiration [RR = 0.76, 95% CI = (0.06-8.88)]; or laryngotracheal soiling [RR = 0.34, 95% CI = (0.10-1.06)]. Patients treated with the FLMA had a lower incidence of hoarseness [RR = 0.31, 95% CI = (0.15-0.62)]; coughing [RR = 0.28, 95% CI = (0.15-0.51)] during recovery in the postanesthesia care unit (PACU); and oxygen desaturation [RR = 0.43, 95% CI = (0.26-0.72)] than did patients treated with ETT. However, the incidence of partial upper airway obstruction in FLMA patients was significantly greater than it was for ETT patients [RR = 4.01, 95% CI = (1.44-11.18)].ConclusionThis systematic review showed that the FLMA has some advantages over ETT because it results in a lower incidence of hoarseness, coughing and oxygen desaturation. There were no statistically significant differences in the difficulty of intubation or in the occurrence of laryngospasms, postoperative sore throat, airway displacement, aspiration or laryngotracheal soiling. However, there was a higher incidence of partial upper airway obstruction in the FLMA than in the ETT group. We conclude that the FLMA has some advantages over ETT, but surgeons and anesthesiologists should be cautious when applying the mouth gag, moving the head and neck, or performing oropharyngeal procedures to avoid partial upper airway obstruction and airway displacement. The FLMA should not be used on patients at high risk for aspiration.

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:BackgroundDesflurane's short emergence time supports fast track anaesthesia. Data on the rate of upper airway complications and emergence time when desflurane is used with laryngeal mask airway (LMA) are controversial and limited.ObjectivesTo compare recovery time variables and the rates of upper airway adverse events in patients with an LMA undergoing general surgery with desflurane, sevoflurane, isoflurane or propofol anaesthesia.DesignA systematic review and meta-analysis of randomised controlled trials (RCTs).Data sourcesA systematic search for eligible RCTs in Embase (Elsevier) and in PubMed (National Library of Medicine) databases up to September 2013.Eligibility criteriaRCTs investigating the rates of cough overall, cough at emergence, laryngospasm, time to eye opening, time to removal of the LMA, time to respond to command and time to state date of birth in patients with an LMA, during emergence from desflurane, sevoflurane, isoflurane or propofol anaesthesia.ResultsThirteen RCTs were included and analysed. We found a strong interstudy variability. There was no difference in the rates of upper airway events between desflurane and sevoflurane or between desflurane and a control group consisting of all the other anaesthetics combined. Comparing desflurane (n = 284) with all other anaesthetic groups (n = 313), the risk ratio [95% confidence interval (95% CI)] was 1.12 (0.63 to 2.02, P = 0.70). Cough at emergence was only measured in patients receiving desflurane (n = 148) and sevoflurane (n = 146): the risk ratio (95% CI) was 1.49 (0.55 to 4.02, P = 0.43). Laryngospasm was rare and there was no significant difference in its incidence when desflurane (n = 262) was compared with all other anaesthetics combined (n = 289; risk ratio 1.03; 95% CI 0.33 to 3.20, P = 0.96). The times of all emergence variables were significantly faster in the desflurane group than in all other groups.ConclusionWhen using an LMA, upper airway adverse reactions in association with desflurane anaesthesia were no different from those noted with sevoflurane, isoflurane or propofol anaesthesia. Emergence from general anaesthesia with desflurane is significantly faster than all the other anaesthetics. Due to interstudy variations and the small size of the trials, further large-scale, multicentre studies are required to confirm or refute the results of this meta-analysis.

Project description:Background:Several studies have identified side effects of general anesthesia with endotracheal intubation, such as laryngeal pain, dysphonia, and postoperative nausea and vomiting (PONV). The laryngeal mask airway (LMAw) is believed to decrease these side effects. The aim of this trial was to compare postoperative discomfort, emergence delirium, and recovery time of patients who received either an LMAw or nasotracheal intubation (NTI). Patients and methods:A total of 70 children were randomly assigned to the LMAw group (n=35) or the NTI group (n=35). Both groups underwent mask induction with 8% sevoflurane. The NTI group received muscle relaxant, whereas the LMAw group did not. Postoperative laryngeal pain, dental pain, dysphonia, and PONV were assessed immediately and at 1 hour and 6 hours postoperatively. The Wong-Baker Faces Scale was used to evaluate the patients' self-reported pain. In addition, decayed, missing, and filled teeth (dft/DMFT) values, dental procedure type, number of dental procedures, duration of the dental operation, duration of anesthesia, recovery time, emergence delirium, pediatric dentist's access to the mouth, and parents' satisfaction levels were recorded. Data were analyzed using descriptive statistics, chi-square tests, and two-sample t-tests. Results:The incidence of postoperative laryngeal pain was significantly higher in the NTI group immediately (97.2% vs. 8.5%, P=0.00), 1 hour (94.2% vs. 0%, P=0.00), and 6 hours postoperatively (25.7% vs. 0%, P=0.00). There were no statistically significant differences between the two groups in dental pain scores, dft/DMFT values, duration of anesthesia, duration of the dental operation, number of dental procedures, the incidence of PONV, or pediatric dentist's access to the mouth (P>0.05). Emergence delirium and recovery time were significantly higher in the NTI group (P<0.05). Conclusion:The LMAw provided a more comfortable postoperative period than NTI for children who underwent full-mouth dental rehabilitation under general anesthesia.

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Comparison of the clinical performance of the flexible laryngeal mask airway in pediatric patients under general anesthesia with or without a muscle relaxant: study protocol for a randomized controlled trial.

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Comparison of the clinical performance of the flexible laryngeal mask airway in pediatric patients under general anesthesia with or without a muscle relaxant: study protocol for a randomized controlled trial.

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