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Comparison of a Polyvinyl Chloride Tube or a Wire-Reinforced Tube for Tracheal Intubation Using the New SaCoVLMTM Video Intubating Laryngeal Mask Airway: A Randomized Controlled Superiority Trial
20 Pages Posted: 6 Jun 2024
More...Abstract
Backgroud: SaCoVLMTM is a new video intubating laryngeal mask airway (ILMA) and the first LMA to realize continuous visual monitoring. The aim of this study was to compare the success rate of intubation with polyvinyl chloride (PVC) tubes and wire-reinforced (WR) tubes through SaCoVLMTM.
Methods: We included adult patients (n=108) aged between 18-85 years scheduled for elective laparoscopic surgery were enrolled from May to December 2022. Participants were randomized to either the PVC or WR group in a 1:1 ratio. The primary outcome was the total success rate of intubation. The secondary outcomes were the first success rate of intubation, the time of tracheal intubation, the site of first contact, the adjustment action for tracheal intubation, hemodynamic fluctuation, and the incidence rates of postoperative adverse events.
Findings: The success rate of first tracheal intubation in the PVC group was significantly higher than that in the WR group (83.3% vs. 64.8%; difference, 18.5%, 95% CI, 1.9-33.9; P = 0.028). The incidence of sore throat at 24 h after surgery in the PVC group was significantly higher than that in the WR group (33.3% vs. 13.0%; difference, -20.4%, 95% CI, -35.2-4.4; P = 0.041).
Interpretation: PVC and WR tubes can be used for safe and effective tracheal intubation via SaCoVLMTM. There is preliminary evidence supporting the benefits of intubation with a WR tube compared to a PVC tube when using the SaCoVLMTM video ILMA. Further studies are needed to validate and expand upon these findings.
Trial Registration: The trial was registered prior to patient enrollment at clinicaltrials.gov (NCT05338827, Principal investigator: Yongtao Sun, Date of registration: 04/14/2022).
Funding: This work was funded by the Natural Science Foundation of Shandong Province (ZR2022MH221), the Academic Promotion Programme of Shandong First Medical University (2019QL015), and the Shandong Medical Association Clinical Research Fund -- Qilu Special Project (YXH2022DZX02007).
Declaration of Interest: The authors declare that they have no competing interests.
Ethical Approval: This study was approved by the Ethics Committee of the First Affiliated Hospital of Shandong First Medical University (YXLL-KY-2022 (008)) and written informed consent was obtained from all subjects participating in the trial. This report followed the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
Keywords: polyvinyl chloride tube, wire-reinforced tube, tracheal intubation, SaCoVLMTM, video laryngeal mask airway
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