Trauma SurgeryNCT07019961
Comparison of the GMA-TULIP and I-gel Laryngeal Mask for Airway Management in General Anaesthesia: a Randomized Controlled Trial
A study testing the GMA-TULIP laryngeal mask and the i-gel laryngeal mask in people with Trauma Surgery and General Anesthesia, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if GMA-TULIP laryngeal mask willfit well in the right place in participants undergoing trauma surgery in a supine position under general anaesthesia. It will also learn about the convenience, effectiveness and safety of the GMA-TULIP laryngeal mask. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Trauma Surgery, General Anesthesia
- What is being tested?
- the GMA-TULIP laryngeal mask and the i-gel laryngeal mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 3 Dec 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤ age ≤ 70 years old. Patients undergoing trauma surgery in a supine position under general anesthesia.
- 18 kg/m2 ≤ BMI ≤ 35 kg/m2. American Society of Anesthesiologists (ASA) grades I-III. Can understand the research process and the use of pain scales. Clear understanding and voluntary participation in the study, signing of informed consent form.
Who cannot join
- Patients with known or predicted difficult airways. High risk of reflux or aspiration (e.g., gastroesophageal reflux disease patients).
- Individuals with active upper respiratory tract infections. Cervical related diseases or surgical history. Preoperative sore throat or previous sore throat or hoarseness. Patients with oral and maxillofacial trauma or fractures. Other reasons why researchers believe it is not appropriate to participate in the experiment.
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
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Shaozhong Yang, Doctor, +86 18560083790, yszyang@163.com
About this study
The goal of this clinical trial is to learn if GMA-TULIP laryngeal mask willfit well in the right place in participants undergoing trauma surgery in a supine position under general anaesthesia.
It will also learn about the convenience, effectiveness and safety of the GMA-TULIP laryngeal mask.
Read more
The main questions it aims to answer are:
Does the GMA-TULIP laryngeal mask exhibit better anatomical alignment? Does the GMA-TULIP laryngeal mask perform effectively in trauma surgery patients in a supine position under general anaesthesia? Researchers will compare with the i-gel laryngeal mask (a device already popular among anaesthetists) to see if the GMA-TULIP laryngeal mask works to have a good performance in general anaesthesia.
Participants will describe feelings immediately after anesthesia， 1 hour later and 24 hours later.
- Conditions
- Trauma Surgery, General Anesthesia
- Being tested
- the GMA-TULIP laryngeal mask, the i-gel laryngeal mask
- Keywords
- GMA-TULIP laryngeal mask, i-gel laryngeal mask, anatomical alignment of laryngeal mask, oropharyngeal leak pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the GMA-TULIP laryngeal maskDevice
insert GMA-TULIP laryngeal masks after anesthesia induction
the i-gel laryngeal maskDevice
insert i-gel laryngeal masks after anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| G group | Experimental | Participants who will use the GMA-TULIP laryngeal mask Receives: Device: the GMA-TULIP laryngeal mask |
| I Group | Active comparator | Participants who will use the i-gel laryngeal mask Receives: Device: the i-gel laryngeal mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of anatomical alignment under fiberoptic bronchoscopy observation
Class I: Vocal cords visible. Class II: Vocal cords and posterior epiglottis visible. Class III: Vocal cords and anterior epiglottis visible, <50% visual obstruction of epiglottis to vocal cords.
Class IV: Vocal cords and anterior epiglottis visible, >50% visual obstruction of epiglottis to vocal cords.
Class V: Vocal cords not visible. We define Class I and II field of view as accurate alignment; Class III and IV vision are defined as poor alignment; Class V vision is defined as alignment failure.
Measured: After insertion of laryngeal mask
Secondary outcomes (13)
Number of laryngeal mask insertions
Measured: After anesthesia induction
Placement time of laryngeal mask
Measured: After anesthesia induction
Difficulty level of laryngeal mask insertion
Measured: After insertion of laryngeal mask
Time of insertion of gastric tube through laryngeal mask airway
Measured: After insertion of laryngeal mask
Number of gastric tube insertions
Measured: After insertion of laryngeal mask
Difficulty level of gastric tube insertion
Measured: After insertion of laryngeal mask
Oral and pharyngeal leakage pressure
Measured: 10 minutes after stable ventilation and 1 hour after ventilation
Accuracy of anatomical alignment under fiberoptic bronchoscopy observation
Measured: 1 hour after ventilation and at the end of surgery
Success rate of initial ventilation placement
Measured: During the anesthesia process
Success rate of intraoperative ventilation
Measured: During the anesthesia process
Number of laryngeal mask adjustments during surgery
Measured: During the anesthesia process
Intraoperative injury situation
Measured: During the surgical process
Postoperative respiratory complications
Measured: Immediately after anesthesia awakening, 1 hour later, 24 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion3 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma SurgeryStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaozhong Yang, Doctor, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019961
- Sponsor's protocol ID
- KYLL-202502-002-01
- Status last verified
- Mar 2025
- First submitted
- 5 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the research is completed, share research data, research plans, statistical analysis plans, informed consent forms, and other data
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the GMA-TULIP and I-gel Laryngeal Mask for Airway Management in General Anaesthesia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07019961
- Acronym / sponsor ID
- KYLL-202502-002-01
- Conditions
- Trauma Surgery, General Anesthesia
- Keywords
- GMA-TULIP laryngeal mask, i-gel laryngeal mask, anatomical alignment of laryngeal mask, oropharyngeal leak pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 3 Dec 2025 (estimated)
- First posted
- 13 Jun 2025 (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.
The goal of this clinical trial is to learn if GMA-TULIP laryngeal mask willfit well in the right place in participants undergoing trauma surgery in a supine position under general anaesthesia.
It will also learn about the convenience, effectiveness and safety of the GMA-TULIP laryngeal mask.
The main questions it aims to answer are:
Does the GMA-TULIP laryngeal mask exhibit better anatomical alignment? Does the GMA-TULIP laryngeal mask perform effectively in trauma surgery patients in a supine position under general anaesthesia? Researchers will compare with the i-gel laryngeal mask (a device already popular among anaesthetists) to see if the GMA-TULIP laryngeal mask works to have a good performance in general anaesthesia.
Participants will describe feelings immediately after anesthesia， 1 hour later and 24 hours later.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G group | Experimental | Device: the GMA-TULIP laryngeal maskParticipants who will use the GMA-TULIP laryngeal mask |
| I Group | Active comparator | Device: the i-gel laryngeal maskParticipants who will use the i-gel laryngeal mask |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years old ≤ age ≤ 70 years old. Patients undergoing trauma surgery in a supine position under general anesthesia.
- 18 kg/m2 ≤ BMI ≤ 35 kg/m2. American Society of Anesthesiologists (ASA) grades I-III. Can understand the research process and the use of pain scales. Clear understanding and voluntary participation in the study, signing of informed consent form.
Key exclusion criteria (2 listed)
- Patients with known or predicted difficult airways. High risk of reflux or aspiration (e.g., gastroesophageal reflux disease patients).
- Individuals with active upper respiratory tract infections. Cervical related diseases or surgical history. Preoperative sore throat or previous sore throat or hoarseness. Patients with oral and maxillofacial trauma or fractures. Other reasons why researchers believe it is not appropriate to participate in the experiment.
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 |
|---|---|---|
| the GMA-TULIP laryngeal maskinsert GMA-TULIP laryngeal masks after anesthesia induction | Device | G group |
| the i-gel laryngeal maskinsert i-gel laryngeal masks after anesthesia induction | Device | I Group |
Primary outcome
Accuracy of anatomical alignment under fiberoptic bronchoscopy observation
Time frame: After insertion of laryngeal mask
Class I: Vocal cords visible. Class II: Vocal cords and posterior epiglottis visible. Class III: Vocal cords and anterior epiglottis visible, <50% visual obstruction of epiglottis to vocal cords. Class IV: Vocal cords and anterior epiglottis visible, >50% visual obstruction of epiglottis to vocal cords. Class V: Vocal cords not visible. We define Class I and II field of view as accurate alignment; Class III and IV vision are defined as poor alignment; Class V vision is defined as alignment failure.
13 secondary outcomes
Number of laryngeal mask insertions
Time frame: After anesthesia induction
Placement time of laryngeal mask
Time frame: After anesthesia induction
Difficulty level of laryngeal mask insertion
Time frame: After insertion of laryngeal mask
Time of insertion of gastric tube through laryngeal mask airway
Time frame: After insertion of laryngeal mask
Number of gastric tube insertions
Time frame: After insertion of laryngeal mask
Difficulty level of gastric tube insertion
Time frame: After insertion of laryngeal mask
Oral and pharyngeal leakage pressure
Time frame: 10 minutes after stable ventilation and 1 hour after ventilation
Accuracy of anatomical alignment under fiberoptic bronchoscopy observation
Time frame: 1 hour after ventilation and at the end of surgery
Success rate of initial ventilation placement
Time frame: During the anesthesia process
Success rate of intraoperative ventilation
Time frame: During the anesthesia process
Number of laryngeal mask adjustments during surgery
Time frame: During the anesthesia process
Intraoperative injury situation
Time frame: During the surgical process
Postoperative respiratory complications
Time frame: Immediately after anesthesia awakening, 1 hour later, 24 hours later
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 13 Jun 2025.
- Individual participant dataSharing planned: Yes. After the research is completed, share research data, research plans, statistical analysis plans, informed consent forms, and other data
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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.
Shaozhong Yang, Doctor study chair
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the GMA-TULIP laryngeal mask and the i-gel laryngeal mask in people with Trauma Surgery and General Anesthesia, run by Qilu Hospital of Shandong 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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 13 Jun 2025. 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 Shaozhong Yang, Doctor (+86 18560083790, yszyang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of anatomical alignment under fiberoptic bronchoscopy observation (time frame: After insertion of laryngeal mask). 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 13 Jun 2025.