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Completed
NCT07125677
Comparison of I-gel and I-gel Plus in Elderly Patients
Conditions: Airway Management in Elderly Patients Using Supra Glottic Airway Under General Anesthesia
Sex: All
Ages: 65 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 43
Sponsor: Dongguk University International Hospital
Location: Dongguk University Ilsan Hospital Goyang-si Gyeonggi-do
Summary
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.
Eligibility 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.
Source: ClinicalTrials.gov (NCT07125677). StuddyBuddy aggregates publicly available trial information.
