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I-gel Plus Comparison Study

NCT07125677 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-01-16

No results posted yet for this study

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

Interventions

DEVICE

I-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.

DEVICE

I-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.

BEHAVIORAL

common

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.

Sponsors & Collaborators

  • Dongguk University International Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-17
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07125677 on ClinicalTrials.gov