OBJECTIVES: To assess the clinical performance of the AmbuAura-i (Aura-i) in children. AIM: To compare the Aura-i with the air-Q intubating laryngeal airway (air-Q) for the purposes of fiberoptic-guided tracheal intubation. BACKGROUND: The Aura-i is a new supraglottic airway designed for tracheal intubation. MATERIALS/ METHODS: One hundred twenty children, ages 1 month to 6 years, were randomized to receive either the Aura-i or air-Q, and divided into three equal subgroups (Group 1, 2, 3) based on weight. The time for successful tracheal intubation was primarily assessed. The ease, time, and number of attempts for successful device insertion, leak pressures, fiberoptic grade of laryngeal view, number of attempts time for removal of the device after tracheal intubation, and complications were secondarily assessed. RESULTS: Device placement, tracheal intubation, and removal after tracheal intubation were successful in all patients. There were no differences in the time to successful tracheal intubation through the Aura-i (32.9 ± 13.3 s), and the air-Q (33.9 ± 13 s; P = 0.68), or fiberoptic grade of view between devices. There was not a statistically significant correlation between the time to intubation and the fiberoptic grade of laryngeal view in any of the groups. There were no statistically significant differences in the overall leak pressures, air-Q (18.3 ± 6.1 cm H(2) O) vs Aura-i (16 ± 5.1 cm H(2) O; P = 0.05). In Group 1 (5-10 kg), leak pressures were higher with the air-Q (23.4 ± 7.2 cm H(2) O) than the Aura-i (16.1 ± 5.2 cm H(2) O; P = 0.001). There were no statistically significant differences in the time for removal between the two devices (P = 0.11). However, with the size 1.5 Aura-i, the pilot balloon of the tracheal tube was removed in order to facilitate the removal of the device after tracheal intubation. CONCLUSIONS: Both devices served as effective conduits for fiberoptic-guided tracheal intubation. The limitation of the narrower proximal airway tube of the size 1.5 Aura-i should be considered if cuffed tracheal tubes are to be utilized.
RCT Entities:
OBJECTIVES: To assess the clinical performance of the Ambu Aura-i (Aura-i) in children. AIM: To compare the Aura-i with the air-Q intubating laryngeal airway (air-Q) for the purposes of fiberoptic-guided tracheal intubation. BACKGROUND: The Aura-i is a new supraglottic airway designed for tracheal intubation. MATERIALS/ METHODS: One hundred twenty children, ages 1 month to 6 years, were randomized to receive either the Aura-i or air-Q, and divided into three equal subgroups (Group 1, 2, 3) based on weight. The time for successful tracheal intubation was primarily assessed. The ease, time, and number of attempts for successful device insertion, leak pressures, fiberoptic grade of laryngeal view, number of attempts time for removal of the device after tracheal intubation, and complications were secondarily assessed. RESULTS: Device placement, tracheal intubation, and removal after tracheal intubation were successful in all patients. There were no differences in the time to successful tracheal intubation through the Aura-i (32.9 ± 13.3 s), and the air-Q (33.9 ± 13 s; P = 0.68), or fiberoptic grade of view between devices. There was not a statistically significant correlation between the time to intubation and the fiberoptic grade of laryngeal view in any of the groups. There were no statistically significant differences in the overall leak pressures, air-Q (18.3 ± 6.1 cm H(2) O) vs Aura-i (16 ± 5.1 cm H(2) O; P = 0.05). In Group 1 (5-10 kg), leak pressures were higher with the air-Q (23.4 ± 7.2 cm H(2) O) than the Aura-i (16.1 ± 5.2 cm H(2) O; P = 0.001). There were no statistically significant differences in the time for removal between the two devices (P = 0.11). However, with the size 1.5 Aura-i, the pilot balloon of the tracheal tube was removed in order to facilitate the removal of the device after tracheal intubation. CONCLUSIONS: Both devices served as effective conduits for fiberoptic-guided tracheal intubation. The limitation of the narrower proximal airway tube of the size 1.5 Aura-i should be considered if cuffed tracheal tubes are to be utilized.
Authors: Eun Jin Ahn; Geun Joo Choi; Hyun Kang; Chong Wha Baek; Yong Hun Jung; Young Cheol Woo; Si Ra Bang Journal: Biomed Res Int Date: 2016-06-23 Impact factor: 3.411
Authors: Senthil G Krishna; Faizaan Syed; Mohammed Hakim; Mumin Hakim; Dmitry Tumin; Giorgio C Veneziano; Joseph D Tobias Journal: Med Devices (Auckl) Date: 2018-10-01