Could a mask replace the breathing tube in liver transplants?

NCT ID NCT07775521

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial is testing whether a second-generation laryngeal mask airway (a soft mask placed in the throat) is as safe and effective as the standard endotracheal tube for keeping the airway open during liver transplant surgery. About 100 adults having their first liver transplant will be randomly assigned to receive one of the two airway devices during anesthesia. The study will track airway-related complications, such as leakage, aspiration, or injury, as well as recovery outcomes, to see if the mask offers a gentler alternative.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Second-generation laryngeal mask airway (a device used to keep the airway open during anesthesia)
What this could lead to
If successful, this could show that a laryngeal mask airway is a safer, less invasive option for airway management during liver transplant surgery, potentially reducing complications and speeding recovery.
What could go wrong
This is a relatively small, early-stage trial, and the laryngeal mask may not work as well as intubation for all patients, especially those with complex needs. There is a risk of airway leakage or aspiration, which could be serious.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * No severe cardiac, pulmonary, or renal organ failure, except for liver disease-related kidney injury, and meeting all of the following criteria: * Left ventricular ejection fraction of at least 50% on echocardiography performed within 3 months before surgery, without moderate or severe valvular stenosis or regurgitation, severe ventricular hypertrophy or dilation, regional wall-motion abnormalities, or a large pericardial effusion. * No severe and uncorrectable coronary artery stenosis involving the left main coronary artery or multiple major coronary vessels. * No acute heart failure or myocardial infarction within 6 months before surgery. * No severe or uncontrolled chronic obstructive or restrictive pulmonary disease, with FEV1/FVC greater than 70% and vital capacity greater than 80% of the predicted value. * No hepatopulmonary syndrome or severe pulmonary hypertension at rest, with mean pulmonary artery pressure no greater than 35 mmHg. * No active pulmonary infection. * Estimated glomerular filtration rate of at least 60 mL/min/1.73 m2, corresponding to chronic kidney disease stage 1 or 2. * Body mass index no greater than 30 kg/m2. * Model for End-Stage Liver Disease score no greater than 30. * The participant and family members are adequately informed, willing and able to comply with all study procedures, and provide written informed consent. Exclusion Criteria: * 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. * History of two or more upper abdominal operations with extensive intra-abdominal adhesions and an expected operative duration greater than 8 hours. * Severe preoperative pulmonary disease meeting criteria for severe respiratory failure, severe chronic obstructive pulmonary disease, or severe restrictive pulmonary disease that is expected to limit tolerance of increased airway pressure. * Severe preoperative cardiac disease, including unstable angina or malignant arrhythmia, severe heart failure, or severe pulmonary hypertension. * Poorly controlled hypertension, defined as resting blood pressure not adequately controlled to 140/90 mmHg or lower despite systematic pharmacologic treatment. * Other severe disease that may limit participation, including poorly controlled diabetes mellitus with glycated hemoglobin greater than 8% after treatment, pulmonary embolism, transient ischemic attack, or stroke. * Known allergy to any anesthetic medication planned in the protocol, including propofol, rocuronium, or sufentanil, or to silicone or polyvinyl chloride materials used in the laryngeal mask airway. * For participants with hepatocellular carcinoma, severe adverse effects after preoperative chemotherapy, radiotherapy, targeted therapy, or immunotherapy, such as severe bone marrow suppression or acute deterioration of hepatic or renal function, resulting in inability to tolerate surgery or anesthesia. * Another concurrent or previously diagnosed malignancy that has not been cured within the previous 5 years, except for malignancies considered clinically curable, such as cervical carcinoma in situ or basal cell carcinoma of the skin. * History of psychiatric illness or cognitive impairment, including epilepsy or dementia, that prevents the participant from understanding or complying with study procedures. * Pregnancy or breastfeeding. * Participation in another interventional clinical study within 3 months before enrollment. * Any other condition that, in the investigator's judgment, may substantially increase study-related risk or interfere with evaluation of study outcomes.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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Contacts and locations

Locations

  • The First Afffliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 450051, China

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