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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400000

    bing chen, PhD, 86 023 62887913, chengbing@cqmu.edu.cn

    Recruiting

Other trials in China

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 groups in NCT06766253
Study groupRoleWhat they receive
GMA-TULIPExperimentalUsing GMA-TULIP non-inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position.
Receives: Device: GMA-TULIP
i-gelActive comparatorUsing i-gel non-inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position.
Receives: Device: GMA-TULIP
BlockBusterActive comparatorUsing 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.

  1. 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)
  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.

  1. First posted9 Jan 2025
  2. Study start21 Aug 2024
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

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)
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.

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.

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