An in Vivo CT Imaging Study of GMA-Tulip, I-gel, and LMA Supreme (GLAM-II)
ConditionSupraglottic Airway Device
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
GMA-Tulip
DeviceUnder 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.
I-gel
DeviceUnder 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.
LMA-Supreme insertion
DeviceUnder 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.
Treatment groups
9 Participants
are divided into 3 treatment groupsGroup A: GMA-TulipExperimental treatment 1 intervention
Group B: I-gelActive comparator 1 intervention
Group C: LMA-SupremeSham comparator 1 intervention
Trial outcomes
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)
Time frame
During CT scanning immediately after laryngeal mask insertion (within 30 minutes of insertion)Secondary outcomes
1
Anatomical alignment of the three laryngeal masks
Assessment of laryngeal inlet coverage (glottis, epiglottis, aryepiglottic folds, arytenoid cartilage, interarytenoid notch) via fiberoptic laryngoscopy (graded as Grade I-IV) and CT imaging.
Time frame
During fiberoptic examination and CT scanning immediately after laryngeal mask insertion2
Degree of local tissue compression
Quantification of epiglottis/tongue compression, displacement distance of the hyoid bone and cricoid cartilage plate, inter-common carotid artery distance, tracheal inner diameter change, and the area of the mask body at the upper edge, lower edge, and middle of the cricoid cartilage plate (via CT imaging)
Time frame
During CT scanning immediately after laryngeal mask insertion.3
Post-extubation complications
Evaluation of mucosal injury (visible bleeding during mask removal), hoarseness (patient-reported), sore throat (VAS 0-10, 0 = no pain, 10 = severe pain), and regurgitation (presence of gastric fluid in the oropharynx) at 24 hours post-extubation.
Time frame
24 hours after laryngeal mask extubationSponsors and contacts
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Source ClinicalTrials.gov