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Safety and feasibility of second-generation laryngeal mask versus endotracheal intubation in adult liver transplantation

Safety and feasibility of second-generation laryngeal mask versus endotracheal intubation in adult liver transplantation: a multicenter, prospective, randomized controlled trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124751
Enrollment
Unknown
Registered
2026-05-17
Start date
2026-05-20
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver transplantation

Interventions

Laryngeal Mask Airway (LMA) :Use laryngeal mask airway for airway management during liver transplantation
Endotracheal Tube (ETT):Use endotracheal tube for airway management during liver transplantation

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Age 18–75 years, no gender restriction; 2. Clinically diagnosed with end-stage liver disease (including liver cancer) and scheduled for elective first-time allogeneic liver transplantation (classic or piggyback technique). For patients with liver cancer, eligibility for liver transplantation must comply with the relevant criteria specified in the China Clinical Practice Guidelines for Liver Transplantation in Liver Cancer (2021 Edition). The etiology of end-stage liver disease includes but is not limited to viral hepatitis cirrhosis, alcoholic cirrhosis, autoimmune liver disease, etc.; 3. Preoperative assessment shows no major airway abnormalities (e.g., severe laryngeal malformation, laryngeal tumor, limited neck mobility, mouth opening = 50%, no moderate or greater valvular stenosis or regurgitation, no severe ventricular hypertrophy, dilation, or segmental wall motion abnormality, and no large pericardial effusion; 5.2 No severe, uncorrectable coronary artery stenosis (e.g., left main or multi-vessel major artery involvement); 5.3 No acute heart failure or myocardial infarction within the 6 months before surgery; 5.4 Pulmonary function tests showing no severe, uncontrolled chronic obstructive pulmonary disease or restrictive lung disease (FEV1/FVC > 70%, vital capacity > 80% of predicted value); 5.5 No hepatopulmonary syndrome or severe pulmonary hypertension at rest (mean pulmonary artery pressure [mPAP] <= 35 mmHg); 5.6 No active pulmonary infection; 5.7 eGFR = 60 mL/min/1.73m^2 (CKD stages 1–2); 6. Body mass index (BMI) = 30 kg/m^2; 7. Model for End-Stage Liver Disease (MELD) score <= 30; 8. The patient and their family members are informed, willing and able to comply with all study procedures, and have provided written informed consent.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. Emergency liver transplantation or repeat liver transplantation; 2. Presence of contraindications to laryngeal mask airway (LMA) or endotracheal intubation, or difficult airway (e.g., severe airway obstruction, severe cervical spine injury, laryngeal edema, limited mouth opening, etc.); 3. Previous history of esophageal or pharyngeal/laryngeal surgery; 4. Presence of high risk for regurgitation and aspiration (e.g., severe gastroesophageal reflux disease, significantly elevated intra-abdominal pressure due to massive ascites, full stomach due to inadequate fasting, etc.); 5. History of two or more upper abdominal surgeries, extensive abdominal adhesions, and anticipated surgery duration > 8 hours; 6. Presence of severe pre-existing pulmonary disease meeting criteria for severe pulmonary insufficiency, or concurrent severe chronic obstructive pulmonary disease or restrictive lung disease, with anticipated intolerance to possible elevated airway pressure; 7. Presence of severe pre-existing cardiac disease (e.g., unstable angina, malignant arrhythmias) meeting criteria for severe cardiac insufficiency, or concurrent severe pulmonary hypertension; 8. Poorly controlled hypertension as judged by the investigator (poorly controlled hypertension is defined as failure to achieve resting blood pressure 8% after treatment; pulmonary embolism; cerebrovascular accident including history of transient ischemic attack or stroke); 10. Known allergy to any anesthetic agents planned for use in the study protocol (e.g., propofol, rocuronium, sufentanil, etc.) or to the silicone/PVC material of the laryngeal mask; 11. Patients with liver cancer who have received preoperative radiotherapy, chemotherapy, targeted therapy, or immunotherapy and developed severe adverse reactions (e.g., severe bone marrow suppression, acute deterioration of liver or renal function) rendering them unable to tolerate surgery and anesthesia; 12. History of or concurrent other untreated malignant tumors within the past 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma of the skin, or other malignancies considered clinically curable; 13. History of psychiatric illness or cognitive dysfunction (including epilepsy or dementia) that would preclude cooperation with or understanding of the study procedures; 14. Pregnancy or breastfeeding; 15. Participation in another interventional clinical study within the past 3 months; 16. Any other condition that, in the investigator's judgment, may significantly increase the study risk or affect the evaluation of study outcomes.

Design outcomes

Primary

MeasureTime frame
Intraoperative airway-related adverse events;

Secondary

MeasureTime frame
Perioperative hemodynamic parameters;Anesthesia maintenance method;Postoperative airway-related complications;Postoperative recovery status;

Countries

China

Contacts

Public ContactGuoying Wang

The First Affiliated Hospital of Guangzhou Medical University

wanggy3@126.com+86 136 3240 7313

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026