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.
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
- 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
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.
- Conditions
- Oropharyngeal Leak Pressure
- 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 group | Role | What they receive |
|---|---|---|
| GMA-TULIP Laryngeal Mask Group(D1 Group) | Experimental | After 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 comparator | After 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 comparator | After 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.
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)
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
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.
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
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.
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
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
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
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
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
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
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
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
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
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
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.
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
Length of surgery
The end of the surgery time minus the start of the surgery time
Measured: 1 minute after the end of surgery
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
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
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
Heart rate
Heart rate
Measured: 1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn
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
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
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.
- First posted20 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 Oropharyngeal Leak PressureStudies 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
- 102 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
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 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 Surgeries With Lateral Position Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06782841
- Acronym / sponsor ID
- 2024.134
- Conditions
- Oropharyngeal Leak Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 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
- 20 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.
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.
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.
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 Laryngeal Mask Group(D1 Group) | Experimental | Device: GMA-TULIP Laryngeal MaskAfter the anesthesia induction, use the GMA-TULIP laryngeal mask as the airway ventilation device. |
| i-gel Laryngeal Mask Group(D2 Group) | Active comparator | Device: i-gel Laryngeal MaskAfter the anesthesia induction, use the i-gel laryngeal mask as an airway ventilation device. |
| BlockBuster Laryngeal Mask Group(D3 Group) | Active comparator | Device: BlockBuster Laryngeal MaskAfter the anesthesia induction is over, use the BlockBuster laryngeal mask as the airway ventilation device. |
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 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.
Key exclusion criteria (6 listed)
- 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.
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-TULIP Laryngeal MaskAfter the anesthesia induction, use the GMA-TULIP laryngeal mask as the airway ventilation device. | Device | GMA-TULIP Laryngeal Mask Group(D1 Group) |
| i-gel Laryngeal MaskAfter the anesthesia induction, use the i-gel laryngeal mask as an airway ventilation device. | Device | i-gel Laryngeal Mask Group(D2 Group) |
| BlockBuster Laryngeal MaskAfter the anesthesia induction is over, use the BlockBuster laryngeal mask as the airway ventilation device. | Device | BlockBuster Laryngeal Mask Group(D3 Group) |
Primary outcome
oropharyngeal leak pressure
Time frame: 1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position
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.
24 secondary outcomes
The rate of first-insertion success
Time frame: 1 minute after the first-attempt insertion of the laryngeal mask
The rate of total-insertion success
Time frame: 1 minute after the airway is successfully controlled.
Time of insertion
Time frame: 1 minute after successful insertion of the laryngeal mask
Times of laryngeal mask adjustment before the successful insertion
Time frame: 1 minute after the airway is successfully controlled.
Success rate of gastric tube insertion through laryngeal mask
Time frame: 1 minute after the laryngeal mask is successful inserted
Airway plateau pressure
Time frame: 1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position
Peak airway pressure
Time frame: 1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position
grade of view on fibreoptic bronchoscopy (indicating the accuracy of laryngeal mask positioning)
Time frame: 1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position
Times of laryngeal mask adjustment during the operation
Time frame: From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia
Times of intraoperative air leakage
Time frame: From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia
Active mouth bleeding rate
Time frame: 1 minute after laryngeal mask removal
incidence of blood staining on the laryngeal mask
Time frame: 1 minute after the laryngeal mask was withdrawn
The incidence of regurgitation
Time frame: From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia
The incidence of aspiration
Time frame: From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia
The incidence of cough
Time frame: From 5 minutes before to 5 minutes after the laryngeal mask withdrawal.
Severity of sore throat
Time frame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery
Length of surgery
Time frame: 1 minute after the end of surgery
Time of laryngeal mask application
Time frame: 1 minute after the laryngeal mask is withdrawn
The incidence of hoarseness
Time frame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery
The incidence of dysphagia
Time frame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery
Heart rate
Time frame: 1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn
systolic blood pressure
Time frame: 1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn
diastolic blood pressure
Time frame: 1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn
mean arterial pressure
Time frame: 1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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 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.