GMA-Tulip, I-gel and the LMA-Supreme (LMA-S) Devices in Airway Management (GLAM-I) (GLAM-I)

GMA-Tulip, I-gel and the LMA-Supreme (LMA-S) Devices in Airway Management Under General Anesthesia, a Randomized Controlled Study (GLAM-I)

Patients were randomly assigned to three supraglottic airway devices (SADs) groups for airway management after anesthesia induced. Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed and other airway management quality was recorded.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Airway Remodeling
• Intervention / Treatment: Device: LMA supreme group; Device: I-gel group; Device: GMA-Tulip

Detailed Description

Mechanical ventilation was volume controlled and time cycled with tidal volumes (6-8 ml/kg) set to maintain peak inspiratory pressures of less than 20 cm H2O and ventilatory frequency adjusted to maintain end-tidal carbon dioxide (PETCO2) at 35-45 mmHg. Then a fiberoptic bronchoscope was passed through airway tube into the device to perform glottic exposure grading. Peak airway pressure, incidence of pharyngalgia, bleeding, hoarseness, and dysphagia were recorded.

• Study Type: Interventional
• Enrollment (Actual): 498
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 18-75 years old;
• American Society of Anesthesiologists (ASA) I-III;
• Body mass index (BMI)<30Kg/m2;
• Scheduled for elective breast or lower abdominal surgery with an estimated duration of less than 4 hours;
• Providing written inform consent.

Exclusion Criteria:

• History of oropharyngeal surgery and anatomical abnormalities;
• Limited movement of the cervical spine;
• High risk of reflux/aspiration;
• Emergency surgery;
• Acute throat inflammation and upper respiratory infection;
• History of chronic bronchitis or asthma;
• Cognitive dysfunction and inability to communicate;
• Participating in other clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LMA Supreme group; Patient in LMA supreme group received device of LMA supreme for airway management (one of supraglottic airway device for airway management during general anesthesia)	Device: LMA supreme group; Patient in this group received LMA supreme (one of laryngeal airway management device) for airway management during general anesthesia
Active Comparator: I-gel group; Patient in I-gel group group received device of I-gel for airway management (one of supraglottic airway device for airway management during general anesthesia)	Device: I-gel group; Patient in this group received I-gel laryngeal (one of laryngeal airway management device) for airway management during general anesthesia
Experimental: GMA-Tulip group; Patient in GMA-Tulip group group received device of GMA-Tulip for airway management (one of supraglottic airway device for airway management during general anesthesia)	Device: GMA-Tulip; Patient in this group received GMA-Tulip (one of laryngeal airway management device) for airway management during general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glottic exposure grading	Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed.	From the insertion of supraglottic airway device to the end of surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak inspiratory pressures	Record peak airway pressure during surgery.	From the insertion of supraglottic airway device to 15 minutes after insertion.
Plateau inspiratory pressures	Record plateau airway pressure during surgery.	From the insertion of supraglottic airway device to 15 minutes after insertion.
Oropharyngeal leak pressure	Measure the oropharyngeal leak pressure after insertion of supraglottic airway device	From the insertion of supraglottic airway device to 30 minutes after insertion
Oropharyngeal leak pressure at 30 and 45 degrees of head rotation	Measure the oropharyngeal leak pressure at 30 and 45 degrees of head rotation after insertion of supraglottic airway device	From the insertion of supraglottic airway device to 30 minutes after insertion
Ventilation quality	Record the ventilation quality after the insertion of supraglottic airway device. In specific, The Ventilation Quality Score consists of three components: presence of normal CO₂ waveform, bilateral symmetrical chest rise, and absence of air leak at 20 mmHg airway pressure. Total scores range 0-3, with 0 indicating poor ventilation quality and 3 representing optimal ventilation.	From the insertion of supraglottic airway device to 15 minutes after insertion
Abnormally ventilation events during surgery	Record the abnormally ventilation events (air leakage, abnormal carbon dioxide wave, higher airway pressure, hypoxemia, supraglottic airway device adjustment, change into intubation) during surgery	From the insertion of supraglottic airway device to the end of surgery
Side effects at the end of surgery	Record side effects (blooding on the supraglottic airway device, pharyngalgia, hoarseness) at the end of surgery.	From the insertion of supraglottic airway device to the patient's transfer to the ward. An average of 3 hours.
Side effects and adverse events 24 hours after surgery	Record side effects (pharyngalgia, hoarseness, cough when drinking), and adverse events (pneumonia, hypoxemia) 24 hours after surgery.	Postoperative day 1.
Nasogastric tube insertion success rate	Record the nasogastric tube insertion success rate	From the initial insertion to the successful placement of nasogastric tube. An average of 20 minutes.
Nasogastric tube insertion attempts	Record the number of attempts for nasogastric tube insertion	From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.
Nasogastric tube insertion time	Record the duration (seconds from insertion initiation to successful placement) of nasogastric tube insertion	From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.
Nasogastric tube insertion difficulty	Record the insertion difficulty (1-3 scale; 1=easy, 3=difficult) of nasogastric tube placement	From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.
Reflux or aspiration risk	Record gas/fluid volume during the surgery	From the insertion of s SAD to the end of surgery. An average of 3 hours.
Supraglottic airway device insertion duration	Record the insertion duration (seconds from insertion initiation to successful placement) of SADs	From the mouth open to the device seated upon encountering resistance, averaging approximately 10 seconds.
Supraglottic airway device insertion difficult	Record the insertion difficulty (1-3 scale; 1=easy, 3=difficult) of SADs	From the mouth open to the device seated upon encountering resistance, averaging approximately 10 seconds.
Supraglottic airway device insertion times	Record the number of SAD insertion attempts.	From the mouth open to the device seated upon encountering resistance or able to ventilation after device's adjustment/reinsertion, averaging approximately 10 seconds.

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Jiangling Wang, Ph. D, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Supraglottic airway device; i-gel; LMA-Supreme; Laryngeal inlet encapsulation; Fiberoptic alignment; Optimal anatomical position
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Airway Remodeling
• Other Study ID Numbers: IRB-2024-356（IIT）

Drug and device information, study documents

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