GMA-Tulip, I-gel and the LMA-Supreme (LMA-S) Devices in Airway Management (GLAM-I) (GLAM-I)

January 5, 2026 updated by: Wang Jiangling, Zhejiang Cancer Hospital

GMA-Tulip, I-gel and the LMA-Supreme (LMA-S) Devices in Airway Management Under General Anesthesia, a Randomized Controlled Study (GLAM-I)

Patients were randomly assigned to three supraglottic airway devices (SADs) groups for airway management after anesthesia induced. Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed and other airway management quality was recorded.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Mechanical ventilation was volume controlled and time cycled with tidal volumes (6-8 ml/kg) set to maintain peak inspiratory pressures of less than 20 cm H2O and ventilatory frequency adjusted to maintain end-tidal carbon dioxide (PETCO2) at 35-45 mmHg. Then a fiberoptic bronchoscope was passed through airway tube into the device to perform glottic exposure grading. Peak airway pressure, incidence of pharyngalgia, bleeding, hoarseness, and dysphagia were recorded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
498

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-75 years old;
  • American Society of Anesthesiologists (ASA) I-III;
  • Body mass index (BMI)<30Kg/m2;
  • Scheduled for elective breast or lower abdominal surgery with an estimated duration of less than 4 hours;
  • Providing written inform consent.

Exclusion Criteria:

  • History of oropharyngeal surgery and anatomical abnormalities;
  • Limited movement of the cervical spine;
  • High risk of reflux/aspiration;
  • Emergency surgery;
  • Acute throat inflammation and upper respiratory infection;
  • History of chronic bronchitis or asthma;
  • Cognitive dysfunction and inability to communicate;
  • Participating in other clinical trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: LMA Supreme group
Patient in LMA supreme group received device of LMA supreme for airway management (one of supraglottic airway device for airway management during general anesthesia)
Device: LMA supreme group
Patient in this group received LMA supreme (one of laryngeal airway management device) for airway management during general anesthesia
Active Comparator: I-gel group
Patient in I-gel group group received device of I-gel for airway management (one of supraglottic airway device for airway management during general anesthesia)
Device: I-gel group
Patient in this group received I-gel laryngeal (one of laryngeal airway management device) for airway management during general anesthesia
Experimental: GMA-Tulip group
Patient in GMA-Tulip group group received device of GMA-Tulip for airway management (one of supraglottic airway device for airway management during general anesthesia)
Device: GMA-Tulip
Patient in this group received GMA-Tulip (one of laryngeal airway management device) for airway management during general anesthesia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glottic exposure grading
Time Frame: From the insertion of supraglottic airway device to the end of surgery.
Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed.
From the insertion of supraglottic airway device to the end of surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peak inspiratory pressures
Time Frame: From the insertion of supraglottic airway device to 15 minutes after insertion.
Record peak airway pressure during surgery.
From the insertion of supraglottic airway device to 15 minutes after insertion.
Plateau inspiratory pressures
Time Frame: From the insertion of supraglottic airway device to 15 minutes after insertion.
Record plateau airway pressure during surgery.
From the insertion of supraglottic airway device to 15 minutes after insertion.
Oropharyngeal leak pressure
Time Frame: From the insertion of supraglottic airway device to 30 minutes after insertion
Measure the oropharyngeal leak pressure after insertion of supraglottic airway device
From the insertion of supraglottic airway device to 30 minutes after insertion
Oropharyngeal leak pressure at 30 and 45 degrees of head rotation
Time Frame: From the insertion of supraglottic airway device to 30 minutes after insertion
Measure the oropharyngeal leak pressure at 30 and 45 degrees of head rotation after insertion of supraglottic airway device
From the insertion of supraglottic airway device to 30 minutes after insertion
Ventilation quality
Time Frame: From the insertion of supraglottic airway device to 15 minutes after insertion
Record the ventilation quality after the insertion of supraglottic airway device. In specific, The Ventilation Quality Score consists of three components: presence of normal CO₂ waveform, bilateral symmetrical chest rise, and absence of air leak at 20 mmHg airway pressure. Total scores range 0-3, with 0 indicating poor ventilation quality and 3 representing optimal ventilation.
From the insertion of supraglottic airway device to 15 minutes after insertion
Abnormally ventilation events during surgery
Time Frame: From the insertion of supraglottic airway device to the end of surgery
Record the abnormally ventilation events (air leakage, abnormal carbon dioxide wave, higher airway pressure, hypoxemia, supraglottic airway device adjustment, change into intubation) during surgery
From the insertion of supraglottic airway device to the end of surgery
Side effects at the end of surgery
Time Frame: From the insertion of supraglottic airway device to the patient's transfer to the ward. An average of 3 hours.
Record side effects (blooding on the supraglottic airway device, pharyngalgia, hoarseness) at the end of surgery.
From the insertion of supraglottic airway device to the patient's transfer to the ward. An average of 3 hours.
Side effects and adverse events 24 hours after surgery
Time Frame: Postoperative day 1.
Record side effects (pharyngalgia, hoarseness, cough when drinking), and adverse events (pneumonia, hypoxemia) 24 hours after surgery.
Postoperative day 1.
Nasogastric tube insertion success rate
Time Frame: From the initial insertion to the successful placement of nasogastric tube. An average of 20 minutes.
Record the nasogastric tube insertion success rate
From the initial insertion to the successful placement of nasogastric tube. An average of 20 minutes.
Nasogastric tube insertion attempts
Time Frame: From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.
Record the number of attempts for nasogastric tube insertion
From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.
Nasogastric tube insertion time
Time Frame: From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.
Record the duration (seconds from insertion initiation to successful placement) of nasogastric tube insertion
From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.
Nasogastric tube insertion difficulty
Time Frame: From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.
Record the insertion difficulty (1-3 scale; 1=easy, 3=difficult) of nasogastric tube placement
From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.
Reflux or aspiration risk
Time Frame: From the insertion of s SAD to the end of surgery. An average of 3 hours.
Record gas/fluid volume during the surgery
From the insertion of s SAD to the end of surgery. An average of 3 hours.
Supraglottic airway device insertion duration
Time Frame: From the mouth open to the device seated upon encountering resistance, averaging approximately 10 seconds.
Record the insertion duration (seconds from insertion initiation to successful placement) of SADs
From the mouth open to the device seated upon encountering resistance, averaging approximately 10 seconds.
Supraglottic airway device insertion difficult
Time Frame: From the mouth open to the device seated upon encountering resistance, averaging approximately 10 seconds.
Record the insertion difficulty (1-3 scale; 1=easy, 3=difficult) of SADs
From the mouth open to the device seated upon encountering resistance, averaging approximately 10 seconds.
Supraglottic airway device insertion times
Time Frame: From the mouth open to the device seated upon encountering resistance or able to ventilation after device's adjustment/reinsertion, averaging approximately 10 seconds.
Record the number of SAD insertion attempts.
From the mouth open to the device seated upon encountering resistance or able to ventilation after device's adjustment/reinsertion, averaging approximately 10 seconds.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang Cancer Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jiangling Wang, Ph. D, Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-2024-356（IIT）

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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