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.
Parallel
Second-Generation Laryngeal Mask Airway
Procedure/SurgeryAfter induction of general anesthesia and adequate neuromuscular blockade, an appropriately sized second-generation laryngeal mask airway will be inserted by an experienced anesthesiologist and connected to a mechanical ventilator.
Endotracheal Intubation Airway Management
Procedure/SurgeryAfter induction of general anesthesia and adequate neuromuscular blockade, conventional oral endotracheal intubation will be performed by an experienced anesthesiologist using an appropriately sized endotracheal tube. After correct tube placement is confirmed by end-tidal carbon dioxide monitoring and symmetric breath sounds, the tube will be connected to a mechanical ventilator.
Incidence of Composite Intraoperative Airway-Related Adverse Events
The number and percentage of participants experiencing at least one intraoperative airway-related adverse event, including clinically significant airway leakage, pulmonary aspiration, laryngospasm, bronchospasm, or airway injury. Clinically significant airway leakage is defined as obvious leakage resulting in an inability to maintain effective ventilation. Pulmonary aspiration is defined as gastric contents or food material detected in the airway. Airway injury includes visible bleeding or laryngeal edema associated with airway device placement. Each component will also be summarized separately.
Perioperative Heart Rate
Heart rate will be measured in beats per minute and compared between the two groups at each predefined perioperative time point.
Perioperative Mean Arterial Pressure
Mean arterial pressure will be measured in mmHg and compared between the two groups at each predefined perioperative time point.
Time to Airway Device Removal
Time in minutes from discontinuation of anesthetic drug administration to removal of the laryngeal mask airway or endotracheal tube.
Incidence of Postoperative Sore Throat
The number and percentage of participants reporting sore throat will be recorded at each assessment. The occurrence and recovery of sore throat during the first 7 days after airway device removal will be compared between the two groups.
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Guangzhou Medical University
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Sponsor institution
