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.