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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
After 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.
After 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.
The First Afffliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGIncidence 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.
Time frame: From initiation of airway device placement through completion of surgery, assessed for up to 8 hours
Perioperative Heart Rate
Heart rate will be measured in beats per minute and compared between the two groups at each predefined perioperative time point.
Time frame: Before anesthesia induction; during airway device placement; within 5 minutes after placement; 30 minutes after the start of surgery; immediately before airway device removal and 5 minutes after removal.
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 frame: Before anesthesia induction; during airway device placement; within 5 minutes after placement; 30 minutes after the start of surgery; immediately before airway device removal and 5 minutes after removal
Time to Airway Device Removal
Time in minutes from discontinuation of anesthetic drug administration to removal of the laryngeal mask airway or endotracheal tube.
Time frame: From discontinuation of anesthetic drug administration until airway device removal, assessed for up to 120 minutes.
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.
Time frame: Within 7 days after airway device removal
Incidence of Postoperative Hoarseness
The number and percentage of participants with postoperative hoarseness will be recorded at each assessment. The occurrence and recovery of hoarseness during the first 7 days after airway device removal will be compared between the two groups.
Time frame: Within 7 days after airway device removal
Intensive Care Unit Length of Stay
The duration in days from the participant's initial postoperative admission to the intensive care unit until discharge from the intensive care unit.
Time frame: From postoperative ICU admission to ICU discharge, assessed up to 3 months after transplantation
Postoperative Hospital Length of Stay
The duration in days from the date of liver transplantation to discharge from the hospital.
Time frame: From the date of liver transplantation to hospital discharge, assessed up to 3 months after transplantation
Incidence of Unplanned Reintubation in the Intensive Care Unit
The number and percentage of participants requiring unplanned endotracheal reintubation in the intensive care unit after initial removal of the laryngeal mask airway or endotracheal tube.
Time frame: From initial airway device removal through discharge from the intensive care unit, assessed for up to 30 days.
Incidence of Postoperative Pulmonary Infection
The number and percentage of participants diagnosed with postoperative pulmonary infection based on clinical findings, laboratory results, microbiological testing, and chest imaging, as applicable.
Time frame: From the end of surgery through 3 months after transplantation
Incidence of Postoperative Acute Respiratory Distress Syndrome
The number and percentage of participants diagnosed with acute respiratory distress syndrome after liver transplantation according to the diagnostic criteria specified in the study protocol.
Time frame: From the end of surgery through 3 months after transplantation
Incidence of Adverse Events and Serious Adverse Events
The number and percentage of participants experiencing adverse events or serious adverse events will be recorded. Events of special interest include serious arrhythmia, heart failure, major bleeding, infection, biliary complications, vascular complications, and early allograft dysfunction. For each event, the onset, severity, management, outcome, and relationship to the assigned airway management intervention will be assessed.
Time frame: From initiation of the assigned airway management intervention through 3 months after transplantation
Incidence of Early Allograft Dysfunction
The number and percentage of participants who develop early allograft dysfunction after liver transplantation according to the predefined diagnostic criteria in the study protocol.
Time frame: Within 7 days after liver transplantation
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