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Oropharyngeal Leak PressureNCT06782841

The Effects of GMA-TULIP, I-gel, and BlockBuster Laryngeal Mask in Surgeries With Lateral Position Under General Anesthesia

A study testing GMA-TULIP Laryngeal Mask, i-gel Laryngeal Mask and BlockBuster Laryngeal Mask in people with Oropharyngeal Leak Pressure, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To compare the efficacy and safety of traditional inflatable laryngeal mask, i-gel non-inflatable laryngeal mask and GMA-TULIP non-inflatable laryngeal mask in surgeries with lateral position under general anesthesia, so that providing evidence for the selection of laryngeal mask in surgeries with lateral position. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Oropharyngeal Leak Pressure
What is being tested?
GMA-TULIP Laryngeal Mask, i-gel Laryngeal Mask and BlockBuster Laryngeal Mask
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 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 surgeries in lateral position with an estimated surgery duration of less than 3 hours under general anesthesia.
  • 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

  • Individuals with an open bite of less than 2cm.
  • Individuals with a history of obvious regurgitation of gastric contents and risk factors for aspiration.
  • Patients with combined pharyngeal and laryngeal lesions.
  • Predicting difficult airway patients.
  • Hearing, intellectual, communication, and cognitive impairments.
  • Any reason that prevents cooperation 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

To compare the efficacy and safety of traditional inflatable laryngeal mask, i-gel non-inflatable laryngeal mask and GMA-TULIP non-inflatable laryngeal mask in surgeries with lateral position under general anesthesia, so that providing evidence for the selection of laryngeal mask in surgeries with lateral position.

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 is only placed in the throat without the need for laryngoscope to expose the glottis, not entering the glottis and trachea, so it will not cause mechanical damage to the vocal cords and trachea. Moreover, the insertion of laryngeal mask reduces the excitation of sympathetic and vagus nerves, has a relatively mild effect on physiological status, and significantly reduces cardiovascular reactions, which is convenient for maintaining hemodynamic stability during anesthesia induction and patients can tolerate the tube better without coughing or agitation during recovery from the anesthesia. Therefore, laryngeal masks are currently widely used in airway management during general anesthesia. Studies have shown that about 3 million patients in the UK National Health Service system receive anesthesia surgery with different types of airway management every year, and the use of laryngeal masks is higher than that of tracheal intubation, accounting for about 56.2%.

Since its introduction, many new laryngeal masks have been improved and applied to clinical practice based on the classic laryngeal mask. A key indicator for evaluating the performance of laryngeal masks is their sealing effect on the airway. Currently, laryngeal masks are mainly divided into two categories: 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. Non-inflatable laryngeal masks are designed with a mirror image of the throat opening and use thermoplastic elastomer materials to achieve a gas tightness effect similar to that of inflatable laryngeal masks. The i-gel laryngeal mask is currently the most commonly used non-inflatable type. A meta-analysis found that the sealing pressure of the i-gel laryngeal mask is higher than that of traditional inflatable laryngeal masks, indicating better airway sealing performance for non-inflatable laryngeal masks. The GMA-TULIP non-inflatable laryngeal mask is a new type of non-inflatable laryngeal mask with advantages such as a C-shaped double gastric tube channel, a stable platform for the tongue base, a soft tissue sealing ring, a prominent epiglottis attachment, and a design that matches the anatomical structure of the throat opening. Compared with inflatable laryngeal masks, the GMA-TULIP mask is more in line with anatomical positioning design, theoretically providing higher sealing effect on the airway.

Although the laryngeal mask has been successfully applied to the airway management of surgeries with lateral position under general anesthesia, its widespread use is limited due to the special position of lateral position, which may lead to laryngeal mask displacement, poor airway tightness, and air leakage. Therefore, exploring a laryngeal mask with better airway sealing effect in surgeries with lateral position under general anesthesia will help promote the clinical application of laryngeal mask, reduce airway injury and hemodynamic fluctuation, and improve patient comfort. To this end, this project plans 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 surgeries with lateral position under general anesthesia, providing clinical evidence for the selection of laryngeal mask in surgeries with lateral position under general anesthesia.

Being tested
GMA-TULIP Laryngeal Mask, i-gel Laryngeal Mask, BlockBuster Laryngeal Mask

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GMA-TULIP Laryngeal MaskDevice

    After the anesthesia induction, use the GMA-TULIP laryngeal mask as the airway ventilation device.

  • i-gel Laryngeal MaskDevice

    After the anesthesia induction, use the i-gel laryngeal mask as an airway ventilation device.

  • BlockBuster Laryngeal MaskDevice

    After the anesthesia induction is over, use the BlockBuster laryngeal mask as the airway ventilation device.

Study groups in NCT06782841
Study groupRoleWhat they receive
GMA-TULIP Laryngeal Mask Group(D1 Group)ExperimentalAfter the anesthesia induction, use the GMA-TULIP laryngeal mask as the airway ventilation device.
Receives: Device: GMA-TULIP Laryngeal Mask
i-gel Laryngeal Mask Group(D2 Group)Active comparatorAfter the anesthesia induction, use the i-gel laryngeal mask as an airway ventilation device.
Receives: Device: i-gel Laryngeal Mask
BlockBuster Laryngeal Mask Group(D3 Group)Active comparatorAfter the anesthesia induction is over, use the BlockBuster laryngeal mask as the airway ventilation device.
Receives: Device: BlockBuster Laryngeal Mask

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. oropharyngeal leak pressure

    After the laryngeal mask is successful inserted, set the fresh gas flow to 3 L/min in manual mode, turn the APL valve to 30 cmH2O, then listen to the neck. When hearing the sound of air leakage, the peak airway pressure at this time is the oropharyngeal leak pressure.

    Measured: 1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position

Secondary outcomes (24)
  1. The rate of first-insertion success

    The successful insertion is defined as oropharyngeal leak pressure higher than 20 cmH2O and grade 1-2 of the laryngeal view under the fibreoptic bronchoscopy (indicating the accuracy of laryngeal mask positioning).

    Measured: 1 minute after the first-attempt insertion of the laryngeal mask

  2. The rate of total-insertion success

    The total successful insertion is defined as ventilation with the allocated laryngeal mask after anesthesia induction

    Measured: 1 minute after the airway is successfully controlled.

  3. Time of insertion

    Insertion time was defined as the time from the opening of the mouth by the operator to the positively insert the laryngeal mask. The time of glottic examination, adjustment between two ventilation insertions, and ventilation was not measured as ventilation insertion time.

    Measured: 1 minute after successful insertion of the laryngeal mask

  4. Times of laryngeal mask adjustment before the successful insertion

    The times of laryngeal mask adjustments before successful laryngeal mask insertion.

    Measured: 1 minute after the airway is successfully controlled.

  5. Success rate of gastric tube insertion through laryngeal mask

    After the laryngeal mask is successful inserted, a fully lubricated 14F gastric tube was inserted through its esophageal drainage tube

    Measured: 1 minute after the laryngeal mask is successful inserted

  6. Airway plateau pressure

    Plateau airway pressure refers to the pressure that a certain amount of gas remains in the lungs against the entire closed system at the end of the passage of air, before the beginning of exhalation. Airway plateau pressure was measured by the anesthesia machine automatically.

    Measured: 1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position

  7. Peak airway pressure

    Peak pressure refers to the maximum pressure produced by the airflow in the closed circuit each time the ventilator delivers a certain amount of gas from the endotracheal tube to the patient's lungs. Peak airway pressure was measured by the anesthesia machine automatically.

    Measured: 1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position

  8. grade of view on fibreoptic bronchoscopy (indicating the accuracy of laryngeal mask positioning)

    After successful insertion of the laryngeal mask, fiberoptic bronchoscopy was used and graded according to the degree of glottic and epiglottis exposure by a 4-point scale system: 1, full view of glottis; 2, vocal cords, arytenoids, and inferior surface of epiglottis visible; 3, only superior surface of epiglottis visible; 4, no part of epiglottis or larynx visible. The grades 1 and 2 were defined as optimal fiberscopic view.

    Measured: 1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position

  9. Times of laryngeal mask adjustment during the operation

    the times of the laryngeal mask adjustment during the operation were recorded

    Measured: From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia

  10. Times of intraoperative air leakage

    intraoperative air leakage is defined as hearing the sound of air leakage at the neck during the operation

    Measured: From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia

  11. Active mouth bleeding rate

    After the laryngeal mask was removed, record whether active bleeding occurred at the patient's mouth

    Measured: 1 minute after laryngeal mask removal

  12. incidence of blood staining on the laryngeal mask

    When the laryngeal mask was pulled out, the laryngeal mask was stained with blood

    Measured: 1 minute after the laryngeal mask was withdrawn

  13. The incidence of regurgitation

    The regurgitation is defined as seeing the gastric content in the mouth

    Measured: From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia

  14. The incidence of aspiration

    The aspiration is defined as seeing the gastric content in the trachea

    Measured: From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia

  15. The incidence of cough

    When the laryngeal mask was pulled out, record whether the patient has cough or not.

    Measured: From 5 minutes before to 5 minutes after the laryngeal mask withdrawal.

  16. Severity of sore throat

    The Prince-Henry score was used to evaluate the degree of sore throat: 0, no pain when coughing; 1, pain only when coughing; 2, pain when breathing deeply, but not at rest; 3, pain at rest, but mild and tolerable; 4, excruciating pain at rest, respectively.

    Measured: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery

  17. Length of surgery

    The end of the surgery time minus the start of the surgery time

    Measured: 1 minute after the end of surgery

  18. Time of laryngeal mask application

    The time of laryngeal mask withdrawn minus the time of successful laryngeal mask insertion is the time of laryngeal mask application

    Measured: 1 minute after the laryngeal mask is withdrawn

  19. The incidence of hoarseness

    Record whether the patient is hoarse when speaking

    Measured: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery

  20. The incidence of dysphagia

    Check the patient can swallow or not

    Measured: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery

  21. Heart rate

    Heart rate

    Measured: 1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn

  22. systolic blood pressure

    systolic blood pressure

    Measured: 1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn

  23. diastolic blood pressure

    diastolic blood pressure

    Measured: 1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn

  24. mean arterial pressure

    mean arterial pressure

    Measured: 1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 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
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06782841
Sponsor's protocol ID
2024.134
Status last verified
Jul 2024
First submitted
5 Jan 2025
Last updated
20 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 Laryngeal Mask, i-gel Laryngeal Mask and BlockBuster Laryngeal Mask in people with Oropharyngeal Leak Pressure, 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 20 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?

oropharyngeal leak pressure (time frame: 1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position). 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 20 Jan 2025.

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