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

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.

Study Overview

• Status: Recruiting
• Conditions: Sore-throat
• Intervention / Treatment: Device: GMA-TULIP

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 Type: Interventional
• Enrollment (Estimated): 195
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bing Chen, PhD; Phone Number: +8617323832352; Email: chenbing@cqmu.edu.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • Recruiting
      • The Second Affiliated Hospital of Chongqing Medical University
      • Contact: bing chen, PhD; Phone Number: 86 023 62887913; Email: chengbing@cqmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients received laparoscopic surgeries with trendelenburg position and an estimated surgery duration of less than 3 hours.
2. Ages between 18 to 80, and body mass index less than 28 kg/m².
3. American Society of Anesthesiologists (ASA) Grades I-III.
4. Patients are willing to participate and be able to understand and sign an informed consent form.

Exclusion Criteria:

1. Patients with a mouth opening less than 2 cm.
2. Patients with risk factors for regurgitation and aspiration of gastric contents.
3. Patients with laryngopharyngeal diseases.
4. Patients with potentially difficult airways.
5. Patients with hearing, intellectual, communication, and cognitive impairments.
6. Any reason that patients could not cooperate with the study or that the researcher deems inappropriate for inclusion in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GMA-TULIP; Using GMA-TULIP non-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.
Active Comparator: i-gel; Using i-gel non-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.
Active Comparator: BlockBuster; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative sore throat	Sore throat is assessed by Prince-Henry pain scores (0 to 4 points)	10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of dysphagia	Check the patient can swallow or not	10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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	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.	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.	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.	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.	1 min after the laryngeal mask is successfully inserted, 5 min after pneumoperitoneum and trendelenburg position
heart rate	heart rate	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	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	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	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	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	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	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	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	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.	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	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	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	1 min after the end of surgery
The incidence of hoarseness	the patient is hoarse when speaking	10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Investigators: Principal Investigator: Bing Chen, The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 5, 2025
• First Submitted That Met QC Criteria: January 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Pharyngitis
• Other Study ID Numbers: 2024.135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) will be available with the responding author when required.
• IPD Sharing Time Frame: The data will become available when publish and keep it for 5 years.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No