I-gel versus I-gel plus for airway sealing in older adults
Comparison of Airway Sealing Pressure Between I-gel® and I-gel Plus® in Elderly Patients Under General Anesthesia
This will test whether I-gel plus gives a better airway seal than I-gel for people aged 65–85 having general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | Dongguk University International Hospital Academic / other |
| Locations | 1 site (Goyang-si, Gyeonggi-do) |
| Trial ID | NCT07125677 on ClinicalTrials.gov |
What this trial studies
This is a prospective crossover comparison of two supraglottic airway devices, I-gel and I-gel plus, in patients aged 65–85 undergoing elective general anesthesia. The primary measure is airway sealing pressure, with secondary outcomes including fixation stability and other performance metrics. Each patient will receive both devices in randomized order and measurements will be taken during procedures lasting under three hours. Both devices are approved by the Korean MFDS and will be used within their approved indications at a single academic center.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65–85 with ASA physical status I–III scheduled for elective general anesthesia lasting less than three hours and without high aspiration risk.
Not a fit: Patients with high aspiration risk, significant obesity (BMI >35 kg/m²), poor dental status preventing fixation, cervical spine instability, anatomical airway abnormalities, active respiratory disease, or pregnancy are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, I-gel plus could provide a stronger airway seal and reduce respiratory complications during anesthesia in older patients, especially for surgeries with higher intra-abdominal pressure.
How similar studies have performed: Previous studies comparing I-gel with other supraglottic devices have shown variable sealing pressures, but direct comparisons between I-gel and I-gel plus, particularly in elderly patients, are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 65-85 years with ASA physical status I-III. * Scheduled for elective surgery under general anesthesia lasting less than 3 hours. Exclusion Criteria: * High risk of aspiration (history of gastrectomy, BMI \>35 kg/m², gastroesophageal reflux disease, hiatal hernia). * Poor dental status preventing I-gel fixation. * Cervical spine instability. * Anatomical abnormalities in mouth or larynx, or high risk of respiratory complications (asthma, COPD, recent pneumonia). * Pregnancy. * Other cases deemed inappropriate by the investigator.
Where this trial is running
Goyang-si, Gyeonggi-do
- Dongguk University Ilsan Hospital — Goyang-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Study coordinator: Hansu Bae Assistant Professor, M.D.
- Email: habae81@gmail.com
- Phone: +82-31-961-7868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.