Hung-Shu Chen1,2, Shih-Chieh Yang3,4, Chih-Fang Chang Chien5, Jan Spielberger5, Kuo-Chuan Hung5, Kao-Chi Chung4. 1. Department of Anesthesiology, E-DA Hospital, I-Shou University, 1, Yida Road, Jiaosu Village, Yanchao District, Kaohsiung City 824, Taiwan, ROC. teasy@pchome.com.tw. 2. Institute of Biomedical Engineering, National Cheng-Kung University, Tainan, Taiwan, ROC. teasy@pchome.com.tw. 3. Department of Orthopedic Surgery, E-DA Hospital, I-Shou University, Kaohsiung, Taiwan, ROC. 4. Institute of Biomedical Engineering, National Cheng-Kung University, Tainan, Taiwan, ROC. 5. Department of Anesthesiology, E-DA Hospital, I-Shou University, 1, Yida Road, Jiaosu Village, Yanchao District, Kaohsiung City 824, Taiwan, ROC.
Abstract
PURPOSE: The ProSeal™ laryngeal mask airway (PLMA™) may be difficult to insert because of its large soft cuff, even when using a dedicated introducer tool. The purpose of this study was to investigate whether introduction of a stylet (Flexi-Slip™) in the drainage tube improved insertion characteristics compared with the standard introducer. METHODS: In this randomized controlled trial, 160 adults were allocated randomly to either the Introducer group (n = 80) or to the Flexi-Slip stylet group (n = 80). In the Introducer group, the PLMA was inserted with an introducer as described in the manufacturer's instructions. In the Flexi-Slip stylet group, a Flexi-Slip stylet was inserted into the drainage tube of the PLMA and bent to form a near 90° angle at the junction of the cuff and the airway tube. The primary outcome measurement was the success rate at first attempt. Insertion time, visible blood staining, and complications were also noted. RESULTS: Success at first attempt was more frequent with the Flexi-Slip stylet than with the introducer (100% vs 86%, respectively; P = 0.001). Overall time (mean ± standard deviation) taken for successful placement was shorter with the Flexi-Slip stylet than with the introducer (19.9 ± 5.6 sec vs 28.4 ± 15.2 sec, respectively; P < 0.001). The incidences of blood staining and postoperative sore throat were lower in the Flexi-Slip stylet group than in the Introducer group (4% vs 15%, respectively; P = 0.015 and 8% vs 23%, respectively; P = 0.008). CONCLUSION: Insertion of the PLMA with a Flexi-Slip stylet has a higher success rate at first attempt, requires less time, and results in fewer airway complications than the introducer technique.
RCT Entities:
PURPOSE: The ProSeal™ laryngeal mask airway (PLMA™) may be difficult to insert because of its large soft cuff, even when using a dedicated introducer tool. The purpose of this study was to investigate whether introduction of a stylet (Flexi-Slip™) in the drainage tube improved insertion characteristics compared with the standard introducer. METHODS: In this randomized controlled trial, 160 adults were allocated randomly to either the Introducer group (n = 80) or to the Flexi-Slip stylet group (n = 80). In the Introducer group, the PLMA was inserted with an introducer as described in the manufacturer's instructions. In the Flexi-Slip stylet group, a Flexi-Slip stylet was inserted into the drainage tube of the PLMA and bent to form a near 90° angle at the junction of the cuff and the airway tube. The primary outcome measurement was the success rate at first attempt. Insertion time, visible blood staining, and complications were also noted. RESULTS: Success at first attempt was more frequent with the Flexi-Slip stylet than with the introducer (100% vs 86%, respectively; P = 0.001). Overall time (mean ± standard deviation) taken for successful placement was shorter with the Flexi-Slip stylet than with the introducer (19.9 ± 5.6 sec vs 28.4 ± 15.2 sec, respectively; P < 0.001). The incidences of blood staining and postoperative sore throat were lower in the Flexi-Slip stylet group than in the Introducer group (4% vs 15%, respectively; P = 0.015 and 8% vs 23%, respectively; P = 0.008). CONCLUSION: Insertion of the PLMA with a Flexi-Slip stylet has a higher success rate at first attempt, requires less time, and results in fewer airway complications than the introducer technique.