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

Last updated: April 27, 2025
Sponsor: Zhejiang Cancer Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anesthesia

Treatment

GMA-Tulip

I-gel group

LMA supreme group

Clinical Study ID

NCT06383494
IRB-2024-356（IIT）
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 durationof less than 4 hours;

  • Providing written inform consent.

Exclusion

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 Design

Total Participants: 498
Treatment Group(s): 3
Primary Treatment: GMA-Tulip
Phase:
Study Start date:
April 30, 2024
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Active - Recruiting

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