Actively Recruiting
I-gel Plus Comparison Study
Led by Dongguk University International Hospital · Updated on 2026-01-16
43
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study compares the airway sealing pressure between I-gel® and I-gel plus® in elderly patients (aged 65-85) undergoing general anesthesia. I-gel® is a supraglottic airway device with a non-inflatable cuff, and I-gel plus® is an improved version with a larger gastric drainage channel, enhanced airway tube, and longer cuff tip for better sealing. The study aims to evaluate differences in sealing pressure and other performance metrics in this population, where anatomical changes may affect device efficacy.
CONDITIONS
Official Title
I-gel Plus Comparison Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 65 to 85 years with ASA physical status I-III
- Scheduled for elective surgery under general anesthesia lasting less than 3 hours
You will not qualify if you...
- High risk of aspiration including history of gastrectomy, BMI over 35 kg/m2, gastroesophageal reflux disease, or hiatal hernia
- Poor dental status preventing I-gel device fixation
- Cervical spine instability
- Anatomical abnormalities in mouth or larynx or high risk of respiratory complications such as asthma, COPD, or recent pneumonia
- Pregnancy
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea, 10323
Actively Recruiting
Research Team
H
Hansu Bae Assistant Professor, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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