AnesthesiaGLAM-INCT06383494
GMA-Tulip, I-gel and the LMA-Supreme (LMA-S) Devices in Airway Management (GLAM-I)
A study testing LMA supreme group, I-gel group and GMA-Tulip in people with Anesthesia and Airway Remodeling, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Airway Remodeling
- What is being tested?
- LMA supreme group, I-gel group and GMA-Tulip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia, Airway Remodeling
- Being tested
- LMA supreme group, I-gel group, GMA-Tulip
- Keywords
- Supraglottic airway device, Laryngeal inlet encapsulation, LMA-Supreme, i-gel, Fiberoptic alignment, Optimal anatomical position
- Medical subject headings
- Airway Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA supreme groupDevice
Patient in this group received LMA supreme (one of laryngeal airway management device) for airway management during general anesthesia
I-gel groupDevice
Patient in this group received I-gel laryngeal (one of laryngeal airway management device) for airway management during general anesthesia
GMA-TulipDevice
Patient in this group received GMA-Tulip (one of laryngeal airway management device) for airway management during general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| LMA Supreme group | Active comparator | Patient in LMA supreme group received device of LMA supreme for airway management (one of supraglottic airway device for airway management during general anesthesia) Receives: Device: LMA supreme group |
| I-gel group | Active comparator | 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) Receives: Device: I-gel group |
| GMA-Tulip group | Experimental | 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) Receives: Device: GMA-Tulip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glottic exposure grading
Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed.
Measured: From the insertion of supraglottic airway device to the end of surgery.
Secondary outcomes (16)
Peak inspiratory pressures
Record peak airway pressure during surgery.
Measured: From the insertion of supraglottic airway device to 15 minutes after insertion.
Plateau inspiratory pressures
Record plateau airway pressure during surgery.
Measured: From the insertion of supraglottic airway device to 15 minutes after insertion.
Oropharyngeal leak pressure
Measure the oropharyngeal leak pressure after insertion of supraglottic airway device
Measured: From the insertion of supraglottic airway device to 30 minutes after insertion
Oropharyngeal leak pressure at 30 and 45 degrees of head rotation
Measure the oropharyngeal leak pressure at 30 and 45 degrees of head rotation after insertion of supraglottic airway device
Measured: From the insertion of supraglottic airway device to 30 minutes after insertion
Ventilation quality
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.
Measured: From the insertion of supraglottic airway device to 15 minutes after insertion
Abnormally ventilation events during 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
Measured: From the insertion of supraglottic airway device to the end of surgery
Side effects at the end of surgery
Record side effects (blooding on the supraglottic airway device, pharyngalgia, hoarseness) at the end of surgery.
Measured: 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
Record side effects (pharyngalgia, hoarseness, cough when drinking), and adverse events (pneumonia, hypoxemia) 24 hours after surgery.
Measured: Postoperative day 1.
Nasogastric tube insertion success rate
Record the nasogastric tube insertion success rate
Measured: From the initial insertion to the successful placement of nasogastric tube. An average of 20 minutes.
Nasogastric tube insertion attempts
Record the number of attempts for nasogastric tube insertion
Measured: From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.
Nasogastric tube insertion time
Record the duration (seconds from insertion initiation to successful placement) of nasogastric tube insertion
Measured: From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.
Nasogastric tube insertion difficulty
Record the insertion difficulty (1-3 scale; 1=easy, 3=difficult) of nasogastric tube placement
Measured: From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.
Reflux or aspiration risk
Record gas/fluid volume during the surgery
Measured: From the insertion of s SAD to the end of surgery. An average of 3 hours.
Supraglottic airway device insertion duration
Record the insertion duration (seconds from insertion initiation to successful placement) of SADs
Measured: From the mouth open to the device seated upon encountering resistance, averaging approximately 10 seconds.
Supraglottic airway device insertion difficult
Record the insertion difficulty (1-3 scale; 1=easy, 3=difficult) of SADs
Measured: From the mouth open to the device seated upon encountering resistance, averaging approximately 10 seconds.
Supraglottic airway device insertion times
Record the number of SAD insertion attempts.
Measured: From the mouth open to the device seated upon encountering resistance or able to ventilation after device's adjustment/reinsertion, averaging approximately 10 seconds.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start30 Apr 2024
- Primary completion31 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Jiangling, Zhejiang Cancer Hospital
- Investigators
- Jiangling Wang, Ph. D, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383494
- Sponsor's protocol ID
- IRB-2024-356（IIT）
- Acronym
- GLAM-I
- Status last verified
- Jan 2026
- First submitted
- 22 Apr 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GMA-Tulip, I-gel and the LMA-Supreme (LMA-S) Devices in Airway Management Under General Anesthesia, a Randomized Controlled Study (GLAM-I)
- ClinicalTrials.gov ID
- NCT06383494
- Acronym / sponsor ID
- GLAM-I / IRB-2024-356（IIT）
- Conditions
- Anesthesia, Airway Remodeling
- Keywords
- Supraglottic airway device, Laryngeal inlet encapsulation, LMA-Supreme, i-gel, Fiberoptic alignment, Optimal anatomical position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 25 Apr 2024 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LMA Supreme group | Active comparator | Device: LMA supreme groupPatient in LMA supreme group received device of LMA supreme for airway management (one of supraglottic airway device for airway management during general anesthesia) |
| I-gel group | Active comparator | Device: I-gel groupPatient in I-gel group group received device of I-gel for airway management (one of supraglottic airway device for airway management during general anesthesia) |
| GMA-Tulip group | Experimental | Device: GMA-TulipPatient in GMA-Tulip group group received device of GMA-Tulip for airway management (one of supraglottic airway device for airway management during general anesthesia) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| LMA supreme groupPatient in this group received LMA supreme (one of laryngeal airway management device) for airway management during general anesthesia | Device | LMA Supreme group |
| I-gel groupPatient in this group received I-gel laryngeal (one of laryngeal airway management device) for airway management during general anesthesia | Device | I-gel group |
| GMA-TulipPatient in this group received GMA-Tulip (one of laryngeal airway management device) for airway management during general anesthesia | Device | GMA-Tulip group |
Primary outcome
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.
16 secondary outcomes
Peak inspiratory pressures
Time frame: 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.
Oropharyngeal leak pressure
Time frame: 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
Ventilation quality
Time frame: 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
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.
Side effects and adverse events 24 hours after surgery
Time frame: 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.
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.
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.
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.
Reflux or aspiration risk
Time frame: 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.
Supraglottic airway device insertion difficult
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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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. This study is not recruiting at the moment.
Jiangling Wang, Ph. D principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMA supreme group, I-gel group and GMA-Tulip in people with Anesthesia and Airway Remodeling, run by Zhejiang Cancer Hospital 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 8 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glottic exposure grading (time frame: From the insertion of supraglottic airway device to the end of surgery.). 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 8 Jan 2026.