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RecruitingNot ApplicableNCT07125677

I-gel Plus Comparison Study

Comparison of Airway Sealing Pressure Between I-gel® and I-gel Plus® in Elderly Patients Under General Anesthesia

Sponsor

Dongguk University International Hospital

Enrollment

43 participants

Start Date

Nov 17, 2025

Study Type

INTERVENTIONAL

Conditions

Airway Management in Elderly Patients Using Supra Glottic Airway Under General Anesthesia

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

Min Age: 65 YearsMax Age: 85 Years

Inclusion Criteria2

  • Patients aged 65-85 years with ASA physical status I-III.
  • Scheduled for elective surgery under general anesthesia lasting less than 3 hours.

Exclusion Criteria6

  • 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.

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Interventions

DEVICEI-gel first

After general anesthesia, I-gel is inserted first, the maximum sealing pressure is measured, and then it is removed. Subsequently, I-gel plus is inserted, and the same procedure is repeated.

DEVICEI-gel plus first

After general anesthesia, I-gel plus is inserted first, the maximum sealing pressure is measured, and then it is removed. Subsequently, I-gel is inserted, and the same procedure is repeated.

BEHAVIORALcommon

Prior to general anesthesia, as a common baseline procedure for all study arms, the patient's Charlson Comorbidity Index and frailty score are assessed and recorded through patient evaluation (using the Clinical Frailty Scale for the frailty score). Immediately before induction of anesthesia, progressive pressures (100 g, 200 g, 300 g, 400 g, and 500 g) are applied to the patient's thyroid cartilage, and the degree of deviation is measured and documented.

Locations(1)

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

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NCT07125677