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

University of Chinese Academy Sciences

Status: Enrolling

Conditions: Airway Remodeling; Anesthesia

Treatments: Device: GMA-Tulip; Device: I-gel group; Device: LMA supreme group

Study type: Interventional

Funder types: Other

Identifiers

NCT06383494

IRB-2024-356（IIT）

Details and patient eligibility

About

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.

Full 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.

Enrollment: 498 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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498 participants in 3 patient groups

LMA Supreme group

Active Comparator group

Description:

Patient in LMA supreme group received device of LMA supreme for airway management (one of supraglottic airway device for airway management during general anesthesia)

Treatment:

Device: LMA supreme group

I-gel group

Active Comparator group

Description:

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)

Treatment:

Device: I-gel group

GMA-Tulip group

Experimental group

Description:

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)

Treatment:

Device: GMA-Tulip