An in Vivo CT Imaging Study of GMA-Tulip, I-gel, and LMA Supreme (GLAM-II)

NCT07196696 | Recruiting DMC

• 1 other identifier: IRB-2025-1160（IIT）
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

Laryngeal masks are core devices for supraglottic airway management, and the accuracy of their anatomical position directly impacts ventilation safety and the incidence of complications. Despite their wide clinical application, gaps remain in understanding their in vivo anatomical characteristics. This study aims to evaluate the in vivo anatomical features (e.g., insertion depth, anatomical alignment, tissue compression) of three laryngeal masks (LMA Supreme, I-gel, GMA-Tulip) using CT scanning in anesthetized patients undergoing CT interventional therapy, providing anatomical evidence for optimized laryngeal mask selection and complication prevention.

Conditions

Supraglottic Airway Device

Keywords

GMA-Tulip; I-gel; LMA-Supreme; Supraglottic airway device

Outcome Measures

Primary Outcomes (1)

• Insertion depth of the three laryngeal masks

  Measurement of the distance from the laryngeal mask tip to the glottis and the upper edge of the 5th cervical vertebra (C5), and the relationship between the mask tip and the cricoid cartilage plate (via CT imaging)

  During CT scanning immediately after laryngeal mask insertion (within 30 minutes of insertion)

Secondary Outcomes (3)

• Anatomical alignment of the three laryngeal masks

  During fiberoptic examination and CT scanning immediately after laryngeal mask insertion

• Degree of local tissue compression

  During CT scanning immediately after laryngeal mask insertion.

• Post-extubation complications

  24 hours after laryngeal mask extubation

Study Arms (3)

GMA-Tulip

EXPERIMENTAL

Insert GMA-Tulip in this group and observe the outcomes

Device: GMA-Tulip

I-gel

ACTIVE COMPARATOR

Insert I-gel in this group and observe the outcomes

Device: I-gel

LMA-Supreme

SHAM COMPARATOR

Insert LMA-Supreme in this group and observe the outcomes

Device: LMA-Supreme insertion

Interventions

GMA-Tulip DEVICE

Under general anesthesia, GMA-Tulip laryngeal mask is inserted following standardized protocols. CT scanning and fiberoptic laryngoscopy are performed to assess insertion depth, anatomical alignment, and tissue compression.

Also known as: GMA-Tulip insertion

GMA-Tulip

I-gel DEVICE

Under general anesthesia, I-gel laryngeal mask is inserted following standardized protocols. CT scanning and fiberoptic laryngoscopy are performed to assess insertion depth, anatomical alignment, and tissue compression.

Also known as: I-gel insertion

I-gel

LMA-Supreme insertion DEVICE

Under general anesthesia, LMA Supreme laryngeal mask is inserted following standardized protocols. CT scanning and fiberoptic laryngoscopy are performed to assess insertion depth, anatomical alignment, and tissue compression.

Also known as: LMA-Supreme

LMA-Supreme

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years, scheduled for CT interventional therapy;
• Aged 18-75 years, scheduled for CT interventional therapy;
• Body Mass Index (BMI) \<30 kg/m²;
• Good communication and cooperation, with voluntary signing of the informed consent form.

You may not qualify if:

• Presence of head/neck or airway anatomical abnormalities (e.g., laryngeal cartilage malformation, Grade III tonsillar hypertrophy, tongue hypertrophy, cervical spine malformation) that may affect laryngeal mask insertion or CT imaging evaluation;
• Current participation in other clinical studies.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (2)

Ethics Committee of Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Jiangling Wang

Hangzhou, Zhejiang, 310022, China

RECRUITING

Study Officials

• Jiangling Wang, Dr

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaochun Jin, M.D

CONTACT

+86 571-88122564; ec@zjcc.org.cn

Jiangling Wang, Dr

CONTACT

wangjl@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: September 29, 2025
• Study Start: October 12, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

CN (2)