An interventional study of GMA-TULIP in Sore-throat, sponsored by The Second Affiliated Hospital of Chongqing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by The Second Affiliated Hospital of Chongqing Medical University · Not applicable, Interventional, and Treatment
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.
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.
226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.
This study's planned enrollment of 195 is above the median of 144 across 188 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →The Second Affiliated Hospital of Chongqing Medical University is the lead sponsor of 102 studies on the registry; 32 are open to participants now.
Compared within Pharyngitis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Using GMA-TULIP non-inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position.
Device: GMA-TULIP
Using i-gel non-inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position.
Device: GMA-TULIP
Using BlockBuster inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position.
Device: GMA-TULIP
Using GMA-TULIP non-inflatable laryngeal mask for airway management in patients who receives laparoscopic surgeries with trendelenburg position.
Incidence of postoperative sore throat
Sore throat is assessed by Prince-Henry pain scores (0 to 4 points)
Time frame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery
incidence of dysphagia
Check the patient can swallow or not
Time frame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery
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.
Time frame: 1 min 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.
Time frame: 1 min after the airway is successfully controlled.
The rate of first-insertion success
The first 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) at the first attempt.
Time frame: 1 min after the first-attempt insertion of the laryngeal mask
Total insertion success rate
The total successful insertion is defined as ventilation with the allocated laryngeal mask after anesthesia induction.
Time frame: 1 min 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
Time frame: 1 min after the laryngeal mask is successful inserted
grade of view on fibreoptic bronchoscopy
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.
Time frame: 1 min after successful insertion of the laryngeal mask, 5 min after pneumoperitoneum and trendelenburg position
oropharyngeal leak pressure
After the laryngeal mask is inserted, set the fresh gas flow to 3 L/min in manual mode, turn the APL valve to 30 cmH2O, and listen to the neck until the sound of air leakage is heard. The peak airway pressure at this time is the oropharyngeal leak pressure.
Time frame: 1 min after the laryngeal mask is successfully inserted, 5 min after pneumoperitoneum and trendelenburg 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.
Time frame: 1 min after the laryngeal mask is successfully inserted, 5 min after pneumoperitoneum and trendelenburg position
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.
Time frame: 1 min after the laryngeal mask is successfully inserted, 5 min after pneumoperitoneum and trendelenburg position
heart rate
heart rate
Time frame: 1 min before laryngeal mask insertion or withdrawn, and 1 min after the laryngeal mask is inserted or withdrawn
diastolic blood pressure
diastolic blood pressure
Time frame: 1 min before laryngeal mask insertion or withdrawn, and 1 min after the laryngeal mask is inserted or withdrawn
systolic blood pressure
systolic blood pressure
Time frame: 1 min before laryngeal mask insertion or withdrawn, and 1 min after the laryngeal mask is inserted or withdrawn
mean arterial pressure
mean arterial pressure
Time frame: 1 min before laryngeal mask insertion or withdrawn, and 1 min after the laryngeal mask is inserted or withdrawn
Times of intraoperative air leakage
intraoperative air leakage is defined as hearing an air leak in the pharynx during the operation
Time frame: From the start of anesthesia to the end of the anesthesia
Times of laryngeal mask adjustment during the operation
the times of the laryngeal mask adjustment during the operation were recorded
Time frame: From the start of anesthesia to the patient's exit from the operating room
The incidence of aspiration
The aspiration is defined as seeing the gastric content in the trachea
Time frame: From the start of anesthesia to the patient's exit from the operating room
The incidence of regurgitation
The regurgitation is defined as seeing the gastric content in the mouth
Time frame: From the start of anesthesia to the patient's exit from the operating room
incidence of blood staining on the laryngeal mask
When the laryngeal mask was pulled out, the laryngeal mask was stained with blood
Time frame: 1 min after the laryngeal mask is pull out after surgery.
The incidence of cough
When the laryngeal mask was pulled out, record whether the patient has cough or not.
Time frame: the time when the laryngeal mask is pull out
Active mouth bleeding rate
After the laryngeal mask was removed, record whether active bleeding occurred at the patient's mouth
Time frame: 1 min after laryngeal mask removal
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
Time frame: 1 min after the laryngeal mask is withdrawn
Length of surgery
The end of the surgery time minus the start of the surgery time is the length of surgery
Time frame: 1 min after the end of surgery
The incidence of hoarseness
the patient is hoarse when speaking
Time frame: 10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery
Plan to share: Yes — Individual participant data (IPD) will be available with the responding author when required.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: The data will become available when publish and keep it for 5 years.
Access criteria: Researchers who provide a methodologically sound proposal.
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