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Ambu AuraOnce versus i-gel laryngeal mask airway in infants and children undergoing surgical procedures. A randomized controlled trial.

ABSTRACT: OBJECTIVES:To compare the efficacy and performance of the pediatric Ambu AuraOnce (Ambu AO) mask (Ambu, Copenhagen, Denmark) and i-gel mask (Intersurgical Ltd., Wokingham, United Kingdom). Methods: From May 2015 to September 2016, 112 patients, 0-14 years old, underwent elective surgery at a tertiary university hospital (Riyadh, Saudi Arabia). They were randomly assigned to the Ambu AO or i-gel group. Three groups underwent a subgroup analysis: ?5 kg (group 1), 5.1-10.0 kg (group 2), and >10 kg (group 3). Results: The oropharyngeal leak pressure was significantly higher for the i-gel (25.4±4.1 cm H2O) than for the Ambu AO (22.5±3.9 cm H2O, p less than 0.001). The Ambu AO had a slightly higher ease of insertion compared to the i-gel (100% versus 94%, p=0.08) and required less manipulation (2% versus 11%, p=0.07).The Ambu AO and i-gel showed non-significant differences in performance between weight groups. There were statistically significant differences for higher leak pressure in group 2 (p=0.01) and group 3 (p=0.002) in favor of the i-gel, and for less manipulation in the Ambu AO in group 1 (p=0.04). Fiberoptic viewing was superior in group 2 for the i-gel (p=0.03) and in group 3 for the Ambu AO (p=0.02). Conclusion: Both devices demonstrated equally good performance with low morbidity. The Ambu AO had a statistical tendency towards easier insertion and less manipulation. Confirming this finding will require large scale trials.

SUBMITTER: Alzahem AM

PROVIDER: S-EPMC5447208 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Ambu AuraOnce versus i-gel laryngeal mask airway in infants and children undergoing surgical procedures. A randomized controlled trial.

Alzahem Abdulrahman M AM Aqil Mansoor M Alzahrani Tariq A TA Aljazaeri Ayman H AH

Saudi medical journal 20170501 5

<h4>Objectives</h4>To compare the efficacy and performance of the pediatric Ambu AuraOnce (Ambu AO) mask (Ambu, Copenhagen, Denmark) and i-gel mask (Intersurgical Ltd., Wokingham, United Kingdom). Methods: From May 2015 to September 2016, 112 patients, 0-14 years old, underwent elective surgery at a tertiary university hospital (Riyadh, Saudi Arabia). They were randomly assigned to the Ambu AO or i-gel group. Three groups underwent a subgroup analysis: ≤5 kg (group 1), 5.1-10.0 kg (group 2), and ...[more]

PMID: 28439597

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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: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:BACKGROUND:Laryngeal mask UNIQUE® (LMAU) is supraglottic airway device with good clinical performance and low failure rate. Little is known about the ideal position of the LMAU on the magnetic resonance imaging (MRI) and whether radiological malposition can be associated with clinical performance (audible leak) in children. The primary aim of the study was to evaluate incidence of the radiologic malposition of the LMAU according to size. The secondary outcome was the clinical performance and associated complications (1st attempt success rate, audible leak) in LMAUs in correct position vs. radiologically misplaced LMAUs. METHODS:In prospective observational study, all paediatric patients undergoing MRI of the brain under general anaesthesia with the LMAU were included (1.9.2016-16.5.2017). The radiologically correct position: LMAU in hypopharynx, proximal cuff opposite to the C1 or C2 and distance A (proximal cuff end and aditus laryngis)???distance B (distal cuff end and aditus laryngis). Malposition A: LMAU outside the hypopharynx. Malposition B: proximal cuff outside C1-C2. Malposition C: distance A???distance B. We measured distances on the MRI image. Malposition incidence between LMAU sizes and first attempt success rate in trainees and consultant groups was compared using Fisher exact test, difference in incidence of malpositions using McNemar test and difference in leakage according to radiological position using two-sample binomial test. RESULTS:Overall 202 paediatric patients were included. The incidence of radiologically defined malposition was 26.2% (n?=?53). Laryngeal mask was successfully inserted on the 1st attempt in 91.1% (n?=?184) cases. Audible leak was detected in 3.5% (n?=?7) patients. The radiologically defined malposition was present in 42.9% (n?=?3) cases with audible leak. The rate of associated complications was 1.5% (n?=?3): laryngospasm, desaturation, cough. In 4.0% (n?=?8) the LMAU was soiled from blood. Higher incidence of radiological malposition was in LMAU 1.0, 1.5 and LMAU 3, 4 compared to LMAU 2 or LMAU 2.5 (p?<?0.001). CONCLUSION:Malposition was not associated with impaired clinical performance (audible leak, complications) of the LMAU or the need for alternative airway management. TRIAL REGISTRATION:Clinicaltrials.gov (NCT02940652) Registered 18 October 18 2016.

Dataset Information

Ambu AuraOnce versus i-gel laryngeal mask airway in infants and children undergoing surgical procedures. A randomized controlled trial.

Publications

Ambu AuraOnce versus i-gel laryngeal mask airway in infants and children undergoing surgical procedures. A randomized controlled trial.

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