Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06782841

Comparing GMA-TULIP, i-gel, and BlockBuster Laryngeal Masks in Surgeries Performed in the Lateral Position Under General Anesthesia

Led by The Second Affiliated Hospital of Chongqing Medical University · Updated on 2025-01-20

102

Participants Needed

1

Research Sites

92 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of three types of laryngeal masks—the traditional inflatable BlockBuster, the non-inflatable i-gel, and the new GMA-TULIP non-inflatable laryngeal mask—in patients undergoing surgeries in the lateral position under general anesthesia. Laryngeal masks are commonly used to manage the airway during anesthesia and are preferred over tracheal intubation because they cause less mechanical damage and maintain hemodynamic stability. The study aims to provide evidence for selecting the best laryngeal mask during surgeries performed in the lateral position, where mask displacement and air leakage can be concerns. Participants will receive one of the three laryngeal masks after anesthesia induction for airway ventilation during surgery. The GMA-TULIP mask features anatomical design improvements, such as a C-shaped double gastric tube channel and a soft tissue sealing ring, potentially offering better airway sealing. The study compares these devices by measuring oropharyngeal leak pressure at specific times after mask insertion, including one minute after insertion and at 5 and 30 minutes while the patient is in the lateral position. During the study, participants will undergo monitoring of airway sealing performance and safety. Researchers will assess the oropharyngeal leak pressure to evaluate how well each mask seals the airway. The study includes patients aged 18 to 80 undergoing surgery expected to last less than 3 hours in the lateral position. Patient consent and ability to participate in assessments are required, and careful monitoring will help determine the best airway management device for these surgical conditions.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing surgeries in the lateral position lasting less than 3 hours under general anesthesia
  • Age between 18 and 80 years
  • Body mass index (BMI) less than 28 kg/m²
  • American Society of Anesthesiologists (ASA) grades I to III
  • Willingness and ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Open bite less than 2 cm
  • History of obvious regurgitation of gastric contents or risk factors for aspiration
  • Presence of pharyngeal and laryngeal lesions
  • Predicted difficult airway
  • Hearing, intellectual, communication, or cognitive impairments
  • Any condition preventing cooperation or deemed unsuitable by the researcher

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400000

Actively Recruiting

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Research Team

B

Bing Chen, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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