This prospective, multicenter, randomized controlled trial aims to evaluate the safety and feasibility of second-generation laryngeal mask airway (LMA) management compared with conventional endotracheal intubation (ETT) during general anesthesia in adults undergoing elective liver transplantation. Approximately 100 participants undergoing their first elective liver transplantation will be randomly assigned in a 1:1 ratio to either the LMA group or the ETT group. The study will primarily evaluate a composite endpoint of intraoperative airway-related adverse events, including clinically significant airway leakage, pulmonary aspiration, laryngospasm, bronchospasm, and airway injury. Conversion from LMA to endotracheal intubation, perioperative hemodynamic changes, blood gas measurements, airway placement and removal times, postoperative airway symptoms, pulmonary complications, intensive care unit length of stay, and postoperative hospital length of stay will also be assessed. Participants will be followed during hospitalization and for 3 months after transplantation to evaluate safety, postoperative recovery, rehospitalization, and survival.
Adults aged 18 to 75 years, regardless of sex.
Clinical diagnosis of end-stage liver disease, including hepatocellular carcinoma, and scheduled to undergo a first elective allogeneic liver transplantation using the conventional or piggyback technique. Participants with hepatocellular carcinoma must meet the indications for liver transplantation specified in the Chinese Clinical Practice Guidelines for Liver Transplantation for Hepatocellular Carcinoma (2021 Edition). Causes of end-stage liver disease may include, but are not limited to, viral hepatitis-related cirrhosis, alcoholic cirrhosis, and autoimmune liver disease.
No severe airway abnormality on preoperative assessment, including severe laryngeal malformation, laryngeal tumor, restricted neck movement, mouth opening less than 3 cm, thyromental distance less than 6.5 cm, or Mallampati class IV.
No history or evidence of a high risk of pulmonary aspiration, including gastric retention, intestinal obstruction, severe gastroesophageal reflux disease, or active upper gastrointestinal bleeding.
Emergency liver transplantation or repeat liver transplantation.
Contraindication to a laryngeal mask airway or endotracheal intubation, or a known or anticipated difficult airway, including severe airway obstruction, severe cervical spine injury, laryngeal edema, or restricted mouth opening.
Previous esophageal or pharyngeal/laryngeal surgery.
High risk of regurgitation or pulmonary aspiration, including severe gastroesophageal reflux disease, markedly increased intra-abdominal pressure due to massive ascites, an inadequately fasted state, or a full stomach.
Guangzhou Medical University
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Sponsor institution