TY - JOUR
T1 - A randomized equivalence trial comparing the i-gel™ and laryngeal mask airway Supreme™ in children
AU - Jagannathan, Narasimhan
AU - Sommers, Katherine
AU - Sohn, Lisa E.
AU - Sawardekar, Amod
AU - Shah, Ravi D.
AU - Mukherji, Isabella I.
AU - Miller, Steven
AU - Voronov, Polina
AU - Seraphin, Sally
PY - 2013/2
Y1 - 2013/2
N2 - Background The laryngeal mask airway Supreme™ (Supreme) is a new single-use supraglottic device with gastric access capability now available in all sizes for children. Objectives To compare the i-gel™ with the Supreme in children for routine airway maintenance. Materials/Methods One hundred and seventy children, aged 3 months to 11 years, 5-50 kg in weight, were randomly assigned to receive either the i-gel™ or the Supreme. The primary outcome measured was airway leak pressure. Secondary outcomes included the following: ease and time for insertion, insertion success rate, fiberoptic grade of view, ease of gastric tube placement, number of airway manipulations, quality of airway during anesthetic maintenance, and complications. Results A total of 168 patients were assessed for the outcomes. The median (IQR [range]) airway leak pressure for the i-gel™ was higher than with the Supreme, 20 (18-25 [9-40]) cm H2O vs 17 (14-22 [10-40]) cm H2O, respectively (P = 0.001). There were no differences in the time for device insertion, fiberoptic grade of view, quality of airway, and complications. Median (IQR[range]) time of successful insertion of a gastric tube was faster with the Supreme, 12 (9.2-14.3 [5.2-44.2]) s than with the i-gel™, 14 (11.9-19 [6.9-75]) s; P = 0.01. The number of airway manipulations during placement was higher with the i-gel™ than with the laryngeal mask airway Supreme (12 vs 13 patients), P = 0.02. Conclusions In infants and children, when a single-use supraglottic device with gastric access capabilities is required, the i-gel™ demonstrated higher airway leak pressures and can be a useful alternative to the Supreme.
AB - Background The laryngeal mask airway Supreme™ (Supreme) is a new single-use supraglottic device with gastric access capability now available in all sizes for children. Objectives To compare the i-gel™ with the Supreme in children for routine airway maintenance. Materials/Methods One hundred and seventy children, aged 3 months to 11 years, 5-50 kg in weight, were randomly assigned to receive either the i-gel™ or the Supreme. The primary outcome measured was airway leak pressure. Secondary outcomes included the following: ease and time for insertion, insertion success rate, fiberoptic grade of view, ease of gastric tube placement, number of airway manipulations, quality of airway during anesthetic maintenance, and complications. Results A total of 168 patients were assessed for the outcomes. The median (IQR [range]) airway leak pressure for the i-gel™ was higher than with the Supreme, 20 (18-25 [9-40]) cm H2O vs 17 (14-22 [10-40]) cm H2O, respectively (P = 0.001). There were no differences in the time for device insertion, fiberoptic grade of view, quality of airway, and complications. Median (IQR[range]) time of successful insertion of a gastric tube was faster with the Supreme, 12 (9.2-14.3 [5.2-44.2]) s than with the i-gel™, 14 (11.9-19 [6.9-75]) s; P = 0.01. The number of airway manipulations during placement was higher with the i-gel™ than with the laryngeal mask airway Supreme (12 vs 13 patients), P = 0.02. Conclusions In infants and children, when a single-use supraglottic device with gastric access capabilities is required, the i-gel™ demonstrated higher airway leak pressures and can be a useful alternative to the Supreme.
KW - airway
KW - clinical trial
KW - devices
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U2 - 10.1111/pan.12078
DO - 10.1111/pan.12078
M3 - Article
C2 - 23189931
AN - SCOPUS:84872060723
SN - 1155-5645
VL - 23
SP - 127
EP - 133
JO - Paediatric anaesthesia
JF - Paediatric anaesthesia
IS - 2
ER -