NCT06383494

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 498 (actual)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Anesthesia
• Airway Remodeling

Interventions

Type	Name	Description
DEVICE	LMA supreme group	Patient in this group received LMA supreme (one of laryngeal airway management 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
DEVICE	GMA-Tulip	Patient in this group received GMA-Tulip (one of laryngeal airway management device) for airway management during general anesthesia

Timeline

• Start date: 2024-04-30
• Primary completion: 2024-12-31
• Completion: 2025-01-01
• First posted: 2024-04-25
• Last updated: 2026-01-08

Locations

1 site across 1 country: China