Comparison of the clinical performance of i-gel and Ambu AuraGain in children: A randomised noninferiority clinical trial
| Autor: | Rika Nakayama, Koui Ka, Takahisa Goto, Takahiro Mihara |
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| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Oropharynx Hemorrhage Anesthesia General Laryngeal Masks law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial 030202 anesthesiology law Pressure Medicine Humans General anaesthesia Elective surgery Disposable Equipment Intraoperative Complications business.industry Incidence (epidemiology) Incidence Infant 030208 emergency & critical care medicine Equipment Design Pharyngeal Diseases Confidence interval Surgery Clinical trial Anesthesiology and Pain Medicine Equivalence Trial Elective Surgical Procedures Child Preschool Cuff Female business |
| Zdroj: | European journal of anaesthesiology. 36(6) |
| ISSN: | 1365-2346 |
| Popis: | BACKGROUND Supraglottic airway devices are commonly used in general anaesthesia in children. The AuraGain is a newly developed disposable second-generation supraglottic airway device with an inflatable cuff and a gastric port. OBJECTIVE To confirm our hypothesis that the oropharyngeal leak pressure (OLP) of the AuraGain would be noninferior to that of the i-gel in paediatric patients. DESIGN A single-blinded, randomised, noninferiority, clinical trial. SETTING Single-centre trial from January to March 2017. PATIENTS One hundred paediatric patients (American Society of Anesthesiologists' physical status 1 to 3), aged up to 12 years old, and body weight of 5 to 30 kg requiring a supraglottic airway for elective surgery with an expected surgery time of less than 2 h under general anaesthesia. INTERVENTION The patients were randomised to allocation to the AuraGain group or the i-gel group. The device size (1.5 to 2.5) used in each group was based on the manufacturer's recommendation. MAIN OUTCOME MEASURES The primary outcome measure was OLP immediately after insertion, with a predefined noninferiority margin of 3 cmH2O. RESULTS The OLP immediately after insertion was lower for the AuraGain than for the i-gel (17.1 vs. 23.0 cmH2O; mean difference: -5.9 cmH2O; 95% confidence interval: -8.5 to -3.3 cmH2O; P = 0.98 and |
| Databáze: | OpenAIRE |
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