GMA-TulipTM, i-gelTM and the LMA-SupremeTM (LMA-S) Devices in Airway Management

Anesthesia Clinical Trial

Official title:

GMA-TulipTM, i-gelTM and the LMA-SupremeTM (LMA-S) Devices in Airway Management Under General Anesthesia, a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06383494
• Other study ID #: IRB-2024-356(IIT)
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2024
• Source: Zhejiang Cancer Hospital
• Contact: Jiangling Wang, Ph.D
• Phone: +86 571 88122106
• Email: wangjl[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 276
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18-75 years old;

• American Society of Anesthesiologists (ASA) I-III;

• Non-emergency full stomach or obstruction;

• Body mass index (BMI)<30Kg/m2;

• Breast or lower abdominal surgery with an estimated duration of less than 4 hours;

• Participate and signed the inform consent with good conmunication and coroperation.

Exclusion Criteria:

• History of oropharyngeal surgery and anatomical abnormalities;

• Emergency, high risk of full stomach, obstruction and reflux aspiration;

• Acute throat inflammation and upper respiratory infection;

• Limited movement of the cervical spine;

• History of chronic bronchitis or asthma;

• Cognitive dysfunction and inability to communicate;

• BMI=30 kg/m2;

• Participating in other clinicaltials or refuse to participate in this trial.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• LMA supreme group
Patient in this group received LMA supreme (one of laryngeal airway management device) for airway management during general anesthesia
• I-gel group
Patient in this group received I-gel laryngeal (one of laryngeal airway management device) for airway management during general anesthesia
• GMA-Tulip
Patient in this group received GMA-Tulip (one of laryngeal airway management device) for airway management during general anesthesia

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glottic exposure grading	Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed	From insertion of supraglottic airway device to the end of surgery
Secondary	Peak inspiratory pressures	Record peak airway pressure during surgery	From insertion of supraglottic airway device to the end of surgery
Secondary	Pharyngalgia	Record pharyngalgia preoperatively	From insertion of supraglottic airway device to 24 hours after surgery
Secondary	Bleeding	Record bleeding preoperatively	From insertion of supraglottic airway device to 24 hours after surgery