Sore-throatNCT06766253
The Effects of GMA-TULIP, I-gel, and BlockBuster Laryngeal Mask in Laparoscopic Surgeries With Trendelenburg Position Under General Anesthesia
A study testing GMA-TULIP in people with Sore-throat, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This project aims to compare the application effects of traditional inflatable BlockBuster laryngeal mask, i-gel non-inflatable laryngeal mask and GMA-TULIP non-inflatable laryngeal mask in laparoscopic surgeries with trendelenburg position under general anesthesia, in order to explore which laryngeal mask is best for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sore-throat
- What is being tested?
- GMA-TULIP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2024to 1 Jun 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients received laparoscopic surgeries with trendelenburg position and an estimated surgery duration of less than 3 hours.
- Ages between 18 to 80, and body mass index less than 28 kg/m².
- American Society of Anesthesiologists (ASA) Grades I-III.
- Patients are willing to participate and be able to understand and sign an informed consent form.
Who cannot join
- Patients with a mouth opening less than 2 cm.
- Patients with risk factors for regurgitation and aspiration of gastric contents.
- Patients with laryngopharyngeal diseases.
- Patients with potentially difficult airways.
- Patients with hearing, intellectual, communication, and cognitive impairments.
- Any reason that patients could not cooperate with the study or that the researcher deems inappropriate for inclusion in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
bing chen, PhD, 86 023 62887913, chengbing@cqmu.edu.cn
About this study
This project aims to compare the application effects of traditional inflatable BlockBuster laryngeal mask, i-gel non-inflatable laryngeal mask and GMA-TULIP non-inflatable laryngeal mask in laparoscopic surgeries with trendelenburg position under general anesthesia, in order to explore which laryngeal mask is best for reducing postoperative throat pain of patients and improving patient comfort and satisfaction.
Read the detailed description
Laryngeal mask and tracheal intubation are the two most commonly used airway management methods for patients under general anesthesia. Compared with tracheal intubation, laryngeal mask has the advantages of simple insertion, less airway injury, and more stable hemodynamics. Therefore, laryngeal mask has been widely used in airway management during general anesthesia. Studies have shown that about 3 million patients in the British National Health Service system receive anesthesia surgery with different types of airway management every year, and the usage rate of laryngeal mask is higher than that of tracheal intubation, accounting for about 56.2%.
Many new laryngeal masks have been improved based on the classic laryngeal mask and applied to clinical practice. Currently, there are two main types of laryngeal masks: inflatable laryngeal masks and non-inflatable laryngeal masks. Inflatable laryngeal masks are traditional types, including BlockBuster, Superme, ProSeal, and Fastrach, which are the most widely used in clinical practice. Traditional laryngeal masks require inflation to achieve sealing of the throat opening, but inflatable laryngeal masks have drawbacks such as inconvenient insertion, higher incidence of oral and pharyngeal injury and bleeding, and a higher incidence of postoperative sore throat. According to report, the incidence of postoperative sore throat with laryngeal masks is up to 31.9%.
The non-inflatable laryngeal mask is mirrored at the throat opening and made of thermoplastic elastomer material, which achieves a gas tightness effect similar to the inflatable laryngeal mask, improves the ease of insertion, and reduces complications such as sore throat and mucosal injury and bleeding. The i-gel laryngeal mask is the most commonly used non-inflated laryngeal mask currently. A meta-analysis found that the incidence of postoperative sore throat with the i-gel laryngeal mask is 4.1%, which is significantly lower than that of inflatable laryngeal masks.
GMA-TULIP is a new type of non-inflatable laryngeal mask with advantages such as C-shaped double gastric tube channel, stable platform for tongue root, soft tissue sealing ring, epiglottis attached protrusion, and consistent with the anatomical structure of the throat. In addition, the front cuff of GMA-TULIP is small, which only needs to reach the two sides of the pyriform fossa in the distal end. During placement, it passes over the tongue root and reaches the standard position. Compared with i-gel non-inflatable laryngeal mask, GMA-TULIP is more in line with the anatomical position design, theoretically better in position, less likely to cause damage to the throat and pharynx, thus, lower incidence of postoperative sore throat.
In laparoscopic surgeries with trendelenburg position under general anesthesia, the airway pressure is significantly higher than that in the supine position and non-laparoscopic surgery, thus, the incidence of postoperative sore throat is higher than that in the supine position and non-laparoscopic surgery. Therefore, this project intends to compare the effects of traditional inflatable BlockBuster laryngeal mask, i-gel non-inflatable laryngeal mask, and GMA-TULIP non-inflatable laryngeal mask in laparoscopic surgeries with trendelenburg position, in order to explore which laryngeal mask is best for reducing postoperative throat pain of patients and improving patient comfort and satisfaction.
- Conditions
- Sore-throat
- Being tested
- GMA-TULIP
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMA-TULIPDevice
Using GMA-TULIP non-inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position.
| Study group | Role | What they receive |
|---|---|---|
| GMA-TULIP | Experimental | Using GMA-TULIP non-inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position. Receives: Device: GMA-TULIP |
| i-gel | Active comparator | Using i-gel non-inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position. Receives: Device: GMA-TULIP |
| BlockBuster | Active comparator | Using BlockBuster inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position. Receives: Device: GMA-TULIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative sore throat
Sore throat is assessed by Prince-Henry pain scores (0 to 4 points)
Measured: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery
Secondary outcomes (1)
incidence of dysphagia
Check the patient can swallow or not
Measured: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start21 Aug 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore-throatStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bing Chen, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766253
- Sponsor's protocol ID
- 2024.135
- Status last verified
- Jul 2024
- First submitted
- 5 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be available with the responding author when required.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of GMA-TULIP, I-gel, and BlockBuster Laryngeal Mask in Laparoscopic Surgeries With Trendelenburg Position Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06766253
- Acronym / sponsor ID
- 2024.135
- Conditions
- Sore-throat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 9 Jan 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.
This project aims to compare the application effects of traditional inflatable BlockBuster laryngeal mask, i-gel non-inflatable laryngeal mask and GMA-TULIP non-inflatable laryngeal mask in laparoscopic surgeries with trendelenburg position under general anesthesia, in order to explore which laryngeal mask is best for reducing postoperative throat pain of patients and improving patient comfort and satisfaction.
Detailed description
Laryngeal mask and tracheal intubation are the two most commonly used airway management methods for patients under general anesthesia. Compared with tracheal intubation, laryngeal mask has the advantages of simple insertion, less airway injury, and more stable hemodynamics. Therefore, laryngeal mask has been widely used in airway management during general anesthesia. Studies have shown that about 3 million patients in the British National Health Service system receive anesthesia surgery with different types of airway management every year, and the usage rate of laryngeal mask is higher than that of tracheal intubation, accounting for about 56.2%.
Many new laryngeal masks have been improved based on the classic laryngeal mask and applied to clinical practice. Currently, there are two main types of laryngeal masks: inflatable laryngeal masks and non-inflatable laryngeal masks. Inflatable laryngeal masks are traditional types, including BlockBuster, Superme, ProSeal, and Fastrach, which are the most widely used in clinical practice. Traditional laryngeal masks require inflation to achieve sealing of the throat opening, but inflatable laryngeal masks have drawbacks such as inconvenient insertion, higher incidence of oral and pharyngeal injury and bleeding, and a higher incidence of postoperative sore throat. According to report, the incidence of postoperative sore throat with laryngeal masks is up to 31.9%.
The non-inflatable laryngeal mask is mirrored at the throat opening and made of thermoplastic elastomer material, which achieves a gas tightness effect similar to the inflatable laryngeal mask, improves the ease of insertion, and reduces complications such as sore throat and mucosal injury and bleeding. The i-gel laryngeal mask is the most commonly used non-inflated laryngeal mask currently. A meta-analysis found that the incidence of postoperative sore throat with the i-gel laryngeal mask is 4.1%, which is significantly lower than that of inflatable laryngeal masks.
GMA-TULIP is a new type of non-inflatable laryngeal mask with advantages such as C-shaped double gastric tube channel, stable platform for tongue root, soft tissue sealing ring, epiglottis attached protrusion, and consistent with the anatomical structure of the throat. In addition, the front cuff of GMA-TULIP is small, which only needs to reach the two sides of the pyriform fossa in the distal end. During placement, it passes over the tongue root and reaches the standard position. Compared with i-gel non-inflatable laryngeal mask, GMA-TULIP is more in line with the anatomical position design, theoretically better in position, less likely to cause damage to the throat and pharynx, thus, lower incidence of postoperative sore throat.
In laparoscopic surgeries with trendelenburg position under general anesthesia, the airway pressure is significantly higher than that in the supine position and non-laparoscopic surgery, thus, the incidence of postoperative sore throat is higher than that in the supine position and non-laparoscopic surgery. Therefore, this project intends to compare the effects of traditional inflatable BlockBuster laryngeal mask, i-gel non-inflatable laryngeal mask, and GMA-TULIP non-inflatable laryngeal mask in laparoscopic surgeries with trendelenburg position, in order to explore which laryngeal mask is best for reducing postoperative throat pain of patients and improving patient comfort and satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GMA-TULIP | Experimental | Device: GMA-TULIPUsing GMA-TULIP non-inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position. |
| i-gel | Active comparator | Device: GMA-TULIPUsing i-gel non-inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position. |
| BlockBuster | Active comparator | Device: GMA-TULIPUsing BlockBuster inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients received laparoscopic surgeries with trendelenburg position and an estimated surgery duration of less than 3 hours.
- Ages between 18 to 80, and body mass index less than 28 kg/m².
- American Society of Anesthesiologists (ASA) Grades I-III.
- Patients are willing to participate and be able to understand and sign an informed consent form.
Key exclusion criteria (6 listed)
- Patients with a mouth opening less than 2 cm.
- Patients with risk factors for regurgitation and aspiration of gastric contents.
- Patients with laryngopharyngeal diseases.
- Patients with potentially difficult airways.
- Patients with hearing, intellectual, communication, and cognitive impairments.
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 |
|---|---|---|
| GMA-TULIPUsing GMA-TULIP non-inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position. | Device | BlockBuster, GMA-TULIP, i-gel |
Primary outcome
Incidence of postoperative sore throat
Time frame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery
Sore throat is assessed by Prince-Henry pain scores (0 to 4 points)
1 secondary outcome
incidence of dysphagia
Time frame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be available with the responding author when required.
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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.
Bing Chen principal investigator
The Second Affiliated Hospital of Chongqing Medical 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 GMA-TULIP in people with Sore-throat, run by The Second Affiliated Hospital of Chongqing 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bing Chen, PhD (+8617323832352, chenbing@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative sore throat (time frame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after 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 9 Jan 2025.