I-gel Plus Comparison Study

Dongguk University International Hospital

Status: Enrolling

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

Treatments: Device: I-gel first; Device: I-gel plus first; Behavioral: common

Study type: Interventional

Funder types: Other

Identifiers

NCT07125677

DUIH 2025-04-012-003

Details and patient eligibility

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.

Full description

Supraglottic airway devices (SGAs) are widely used as alternatives to endotracheal intubation in anesthesiology and emergency medicine. The I-gel® (Intersurgical Ltd., UK) features a non-inflatable cuff for ease of insertion and excellent sealing. The I-gel plus® improves on this with a larger gastric channel, better airway tube, and extended cuff tip to enhance sealing pressure.

Prior studies compared I-gel® to other SGAs like ProSeal or Supreme, showing variable sealing pressures, but direct comparisons between I-gel® and I-gel plus®, especially in elderly patients, are lacking. Elderly patients may experience upper airway anatomical changes affecting SGA performance. Higher sealing pressure is crucial for surgeries with increased intra-abdominal pressure (e.g., laparoscopic or robotic surgery) and can reduce respiratory complications in patients with airway hypersensitivity.

This prospective crossover study will quantitatively assess differences in sealing pressure, fixation stability, and other outcomes. Both devices are approved by the Korean MFDS and will be used within approved indications for academic evaluation of efficacy in elderly patients.

Enrollment: 43 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Group I

Experimental group

Description:

Patients receive I-gel® first, followed by removal and insertion of I-gel plus®.

Treatment:

Behavioral: common

Device: I-gel first

Group P

Active Comparator group

Description:

Patients receive I-gel plus® first, followed by removal and insertion of I-gel®.

Treatment:

Behavioral: common

Device: I-gel plus first