An interventional study of Second-Generation Laryngeal Mask Airway and Endotracheal Intubation Airway Management in Liver Allograft, sponsored by Guangzhou Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Guangzhou Medical University · Not applicable, Interventional, and Treatment
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.
Guangzhou Medical University is the lead sponsor of 40 studies on the registry; 21 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive airway management with an appropriately sized second-generation laryngeal mask airway during general anesthesia for elective liver transplantation. The device will be inserted after anesthesia induction and connected to a mechanical ventilator. Participants will receive standardized perioperative anesthesia and routine liver transplantation care. If effective ventilation cannot be maintained, regurgitation or pulmonary aspiration occurs, persistent laryngospasm or bronchospasm develops, surgical conditions require intubation, or the anesthesiologist considers intubation necessary for safety, the participant will be promptly converted to endotracheal intubation.
Procedure: Second-Generation Laryngeal Mask Airway
Participants assigned to this arm will receive conventional oral endotracheal intubation for airway management during general anesthesia for elective liver transplantation. An appropriately sized endotracheal tube will be inserted after anesthesia induction and connected to a mechanical ventilator. Participants will receive standardized perioperative anesthesia and routine liver transplantation care consistent with that provided to the experimental group, except for the assigned airway management device.
Procedure: Endotracheal Intubation Airway Management
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.
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.
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
Plan to share: Yes — De-identiffed individual participant data (IPD) underlying the primary and secondary outcome results,including baseline characteristics, intervention assignment, and outcome measures, will be shared.
Supporting information: Study protocol
Time frame: IPD and supporting information will be available after publication of the primary study results, beginningapproximately 6 months after publication, and will remain available for up to 5 years.
Access criteria: Access to de-identiffed IPD and supporting information will be granted to qualiffed researchers upon reasonable request. Requests must include a brief research proposal and analysis plan and be approved bythe study investigators. Data will be shared for academic research purposes only, without any attempt to re-identify participants. Data will be provided through secure data transfer methods.
Data sharing details ↗ · www.gyfyyy.cn
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Apr 2027, 8 months later.
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Guangzhou Medical University