Abstract：
This study aimed to investigate the overall success of tracheal intubation using the intubating Laryngeal Tube Suction-Disposable (iLTS-D™, VBM, Sulz a. N., Germany) compared to the Laryngeal Mask Airway (LMA) Fastrach™ (Teleflex, Athlone, Ireland). We hypothesised that the iLTS-D™ would be non-inferior to the LMA Fastrach™ for tracheal intubation and ventilation.
Multicentric, non-inferiority, randomised controlled study.
Operating rooms from two tertiary and one secondary centre in Switzerland from January 2017 to July 2019. The investigators were trained anaesthetists with extensive experience with laryngeal masks but limited to laryngeal tubes. The study was discontinued after the planned interim analysis.
Ninety-nine adult patients were included after randomisation. The inclusion criteria were American Society of Anesthesiologists physical status 1 to 3 in patients scheduled for elective surgery requiring tracheal intubation. Patients with a history of difficult intubation were excluded.
After anaesthesia induction and once neuromuscular blockade was obtained, ventilation was initiated, and tracheal intubation was performed through the randomised device with the flexible endoscope tip placed proximally to the tip of the tracheal tube (visualised blind intubation).
The primary outcome was the intubation success rate after two attempts. The secondary outcomes were time to intubation, successful ventilation rate, time to achieve ventilation, and gastric access success rate.
The overall intubation success rate was significantly higher in the Fastrach™ group than in the iLTS-D™ group (91.8% vs 70.0%, p = 0.006). No difference was found in the ventilation success rate (94% for iLTS-D™ and 100% for LMA Fastrach™ [p = 0.829]). The time to achieve ventilation and intubation were similar between the groups. No major airway complications were noted.
Although both supraglottic devices provided the same effective ventilation rate, the LMA Fastrach™ was superior to the iLTS-D™ as a conduit for intubation in 99 adult patients without a known difficult intubation. These preliminary results need to be confirmed in studies that include a larger population.
Clinicaltrials.gov, 21.09.2016, Identification Number NCT02922595.
Multicentric, non-inferiority, randomised controlled study.
Operating rooms from two tertiary and one secondary centre in Switzerland from January 2017 to July 2019. The investigators were trained anaesthetists with extensive experience with laryngeal masks but limited to laryngeal tubes. The study was discontinued after the planned interim analysis.
Ninety-nine adult patients were included after randomisation. The inclusion criteria were American Society of Anesthesiologists physical status 1 to 3 in patients scheduled for elective surgery requiring tracheal intubation. Patients with a history of difficult intubation were excluded.
After anaesthesia induction and once neuromuscular blockade was obtained, ventilation was initiated, and tracheal intubation was performed through the randomised device with the flexible endoscope tip placed proximally to the tip of the tracheal tube (visualised blind intubation).
The primary outcome was the intubation success rate after two attempts. The secondary outcomes were time to intubation, successful ventilation rate, time to achieve ventilation, and gastric access success rate.
The overall intubation success rate was significantly higher in the Fastrach™ group than in the iLTS-D™ group (91.8% vs 70.0%, p = 0.006). No difference was found in the ventilation success rate (94% for iLTS-D™ and 100% for LMA Fastrach™ [p = 0.829]). The time to achieve ventilation and intubation were similar between the groups. No major airway complications were noted.
Although both supraglottic devices provided the same effective ventilation rate, the LMA Fastrach™ was superior to the iLTS-D™ as a conduit for intubation in 99 adult patients without a known difficult intubation. These preliminary results need to be confirmed in studies that include a larger population.
Clinicaltrials.gov, 21.09.2016, Identification Number NCT02922595.
摘要：
本研究旨在调查使用插管喉管抽吸一次性（iLTS-D™，VBM,Sulza.N.，德国）与喉罩气道（LMA）Fastrach™（Teleflex，阿斯隆,爱尔兰)。我们假设iLTS-D™在气管插管和通气方面不劣于LMAFastrach™。
多中心,非自卑，随机对照研究。
2017年1月至2019年7月，来自瑞士两个三级中心和一个二级中心的手术室。研究人员是受过训练的麻醉师，他们对喉罩有丰富的经验，但仅限于喉管。在计划的中期分析后停止研究。
随机分组后纳入了99名成年患者。入选标准是美国麻醉医师协会的身体状况1至3，患者计划进行需要气管插管的择期手术。有困难插管史的患者被排除在外。
麻醉诱导后，一旦获得神经肌肉阻滞，开始通风，通过随机装置进行气管插管,并将柔性内窥镜尖端放置在气管导管尖端的近侧(可视化盲插管).
主要结果是两次尝试后的插管成功率。次要结果是插管时间，成功通气率，时间来实现通风，和胃通道成功率。
Fastrach™组的总体插管成功率明显高于iLTS-D™组（91.8%vs70.0%，p=0.006)。通气成功率无差异（iLTS-D™为94%，LMAFastrach™为100%[p=0.829]）。两组之间达到通气和插管的时间相似。无重大气道并发症。
虽然两种声门上装置提供了相同的有效通气率，在99例没有已知困难插管的成年患者中,LMAFastrach™作为插管导管优于iLTS-D™.这些初步结果需要在包括更大人群的研究中得到证实。
Clinicaltrials.gov,21.09.2016，标识号NCT02922595。
多中心,非自卑，随机对照研究。
2017年1月至2019年7月，来自瑞士两个三级中心和一个二级中心的手术室。研究人员是受过训练的麻醉师，他们对喉罩有丰富的经验，但仅限于喉管。在计划的中期分析后停止研究。
随机分组后纳入了99名成年患者。入选标准是美国麻醉医师协会的身体状况1至3，患者计划进行需要气管插管的择期手术。有困难插管史的患者被排除在外。
麻醉诱导后，一旦获得神经肌肉阻滞，开始通风，通过随机装置进行气管插管,并将柔性内窥镜尖端放置在气管导管尖端的近侧(可视化盲插管).
主要结果是两次尝试后的插管成功率。次要结果是插管时间，成功通气率，时间来实现通风，和胃通道成功率。
Fastrach™组的总体插管成功率明显高于iLTS-D™组（91.8%vs70.0%，p=0.006)。通气成功率无差异（iLTS-D™为94%，LMAFastrach™为100%[p=0.829]）。两组之间达到通气和插管的时间相似。无重大气道并发症。
虽然两种声门上装置提供了相同的有效通气率，在99例没有已知困难插管的成年患者中,LMAFastrach™作为插管导管优于iLTS-D™.这些初步结果需要在包括更大人群的研究中得到证实。
Clinicaltrials.gov,21.09.2016，标识号NCT02922595。
