Liver AllograftNCT07775521
Second-Generation Laryngeal Mask Airway vs Endotracheal Intubation in Adult Liver Transplantation
A study testing Second-Generation Laryngeal Mask Airway and Endotracheal Intubation Airway Management in people with Liver Allograft, run by Guangzhou Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Allograft
- What is being tested?
- Second-Generation Laryngeal Mask Airway and Endotracheal Intubation Airway Management
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Afffliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 450051
The First Afffliated Hospital of Guangzhou Medical University, 021-81566265
About this study
Official title: Safety and Feasibility of Second-Generation Laryngeal Mask Airway Versus Endotracheal Intubation for Anesthesia in Adult Liver Transplantation: A Multicenter, Prospective, Randomized Controlled Clinical Trial
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.
- Conditions
- Liver Allograft
- Being tested
- Second-Generation Laryngeal Mask Airway, Endotracheal Intubation Airway Management
- Keywords
- ERAS, laryngeal mask airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second-Generation Laryngeal Mask AirwayProcedure or surgery
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.
Endotracheal Intubation Airway ManagementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Second-Generation Laryngeal Mask Airway Group | Experimental | 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. Receives: Procedure: Second-Generation Laryngeal Mask Airway |
| Endotracheal Intubation Group | Active comparator | 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. Receives: Procedure: Endotracheal Intubation Airway Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From initiation of airway device placement through completion of surgery, assessed for up to 8 hours
Secondary outcomes (12)
Perioperative Heart Rate
Heart rate will be measured in beats per minute and compared between the two groups at each predefined perioperative time point.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 7 days after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start3 Aug 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver AllograftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoying Wang, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775521
- Sponsor's protocol ID
- GYYFY-LMA-LT-2026-001
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Second-Generation Laryngeal Mask Airway Versus Endotracheal Intubation for Anesthesia in Adult Liver Transplantation: A Multicenter, Prospective, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07775521
- Acronym / sponsor ID
- GYYFY-LMA-LT-2026-001
- Conditions
- Liver Allograft
- Keywords
- ERAS, laryngeal mask airway
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Second-Generation Laryngeal Mask Airway Group | Experimental | Procedure: Second-Generation Laryngeal Mask AirwayParticipants 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. |
| Endotracheal Intubation Group | Active comparator | Procedure: Endotracheal Intubation Airway ManagementParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Second-Generation Laryngeal Mask AirwayAfter 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. | Procedure or surgery | Second-Generation Laryngeal Mask Airway Group |
| Endotracheal Intubation Airway ManagementAfter 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. | Procedure or surgery | Endotracheal Intubation Group |
Primary outcome
Incidence of Composite Intraoperative Airway-Related Adverse Events
Time frame: From initiation of airway device placement through completion of surgery, assessed for up to 8 hours
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.
12 secondary outcomes
Perioperative Heart Rate
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
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 frame: From discontinuation of anesthetic drug administration until airway device removal, assessed for up to 120 minutes.
Incidence of Postoperative Sore Throat
Time frame: Within 7 days after airway device removal
Incidence of Postoperative Hoarseness
Time frame: Within 7 days after airway device removal
Intensive Care Unit Length of Stay
Time frame: From postoperative ICU admission to ICU discharge, assessed up to 3 months after transplantation
Postoperative Hospital Length of Stay
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
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
Time frame: From the end of surgery through 3 months after transplantation
Incidence of Postoperative Acute Respiratory Distress Syndrome
Time frame: From the end of surgery through 3 months after transplantation
Incidence of Adverse Events and Serious Adverse Events
Time frame: From initiation of the assigned airway management intervention through 3 months after transplantation
Incidence of Early Allograft Dysfunction
Time frame: Within 7 days after liver transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Second-Generation Laryngeal Mask Airway and Endotracheal Intubation Airway Management in people with Liver Allograft, run by Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoying Wang (021-81566265, wanggy3@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Composite Intraoperative Airway-Related Adverse Events (time frame: From initiation of airway device placement through completion of surgery, assessed for up to 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.