I-gel Plus Comparison Study

NCT07125677 | Recruiting

• 1 other identifier: DUIH 2025-04-012-003
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

I-gel study; SGA study; Elderly patients

Outcome Measures

Primary Outcomes (1)

• Airway Sealing Pressure

  Comparison of sealing pressure (cm H2O) between I-gel® and I-gel plus®, measured after insertion with fresh gas flow at 3 L/min and valve closed.

  During surgery, immediately after each device insertion

Secondary Outcomes (4)

• Fixation Stability

  During surgery

• Time to Successful Insertion

  During surgery

• Ease of Insertion

  During surgery

• Operator Complications

  Post-surgery up to 24 hours

Study Arms (2)

Group I

EXPERIMENTAL

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

Device: I-gel first; Behavioral: common

Group P

ACTIVE COMPARATOR

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

Device: I-gel plus first; Behavioral: common

Interventions

I-gel first DEVICE

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.

Group I

I-gel plus first DEVICE

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.

Group P

common BEHAVIORAL

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.

Group I; Group P

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dongguk University International Hospital: lead

Study Sites (1)

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 10323, South Korea

RECRUITING

Central Study Contacts

Hansu Bae Assistant Professor, M.D.

CONTACT

+82-31-961-7868; habae81@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No blinding is implemented.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Prospective crossover design where patients are randomized to receive either I-gel first followed by I-gel plus (Group I) or vice versa (Group P)

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 15, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)