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Clinical Trials/NCT06782841
NCT06782841RecruitingNot Applicable

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

The Second Affiliated Hospital of Chongqing Medical University1 site in 1 country102 target enrollmentStarted: August 21, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
102
Locations
1
Primary Endpoint
oropharyngeal leak pressure

Study Overview

Brief 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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

GMA-TULIP Laryngeal Mask Group(D1 Group)

Experimental

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

Intervention: GMA-TULIP Laryngeal Mask (Device)

i-gel Laryngeal Mask Group(D2 Group)

Active Comparator

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

Intervention: i-gel Laryngeal Mask (Device)

BlockBuster Laryngeal Mask Group(D3 Group)

Active Comparator

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

Intervention: BlockBuster Laryngeal Mask (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • The incidence of dysphagia(10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery)
  • The rate of first-insertion success(1 minute after the first-attempt insertion of the laryngeal mask)
  • The rate of total-insertion success(1 minute after the airway is successfully controlled.)
  • Time of insertion(1 minute after successful insertion of the laryngeal mask)
  • Times of laryngeal mask adjustment before the successful insertion(1 minute after the airway is successfully controlled.)
  • Success rate of gastric tube insertion through laryngeal mask(1 minute after the laryngeal mask is successful inserted)
  • Airway plateau pressure(1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position)
  • Peak airway pressure(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)(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(From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia)
  • Times of intraoperative air leakage(From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia)
  • Active mouth bleeding rate(1 minute after laryngeal mask removal)
  • incidence of blood staining on the laryngeal mask(1 minute after the laryngeal mask was withdrawn)
  • The incidence of regurgitation(From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia)
  • The incidence of aspiration(From 1 minute after the beginning of anesthesia to 1 minute after the end of anesthesia)
  • The incidence of cough(From 5 minutes before to 5 minutes after the laryngeal mask withdrawal.)
  • Severity of sore throat(10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery)
  • Length of surgery(1 minute after the end of surgery)
  • Time of laryngeal mask application(1 minute after the laryngeal mask is withdrawn)
  • The incidence of hoarseness(10 minutes, 2 hours, 24 hours, 48 hours, and 72 hours after surgery)
  • Heart rate(1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn)
  • systolic blood pressure(1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn)
  • diastolic blood pressure(1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn)
  • mean arterial pressure(1 minute before laryngeal mask insertion or withdrawn, and 1 minute after the laryngeal mask is inserted or withdrawn)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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