Comparison of I-gel and I-gel Plus in Elderly Patients
July 8, 2026 updated by: Hansu Bae, Dongguk University International Hospital
Comparison of Airway Sealing Pressure Between I-gel® and I-gel Plus® in Elderly Patients Under General Anesthesia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, South Korea, 10323
- Dongguk University Ilsan Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I
Patients receive I-gel® first, followed by removal and insertion of I-gel plus®.
|
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.
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.
|
|
Active Comparator: Group P
Patients receive I-gel plus® first, followed by removal and insertion of I-gel®.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Airway Sealing Pressure
Time Frame: During surgery, immediately after each device insertion
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fixation Stability
Time Frame: During surgery
|
Assessment of device position maintenance after insertion (device movement yes/no).
|
During surgery
|
|
Time to Successful Insertion
Time Frame: During surgery
|
Time from start of insertion to complete EtCO2 curve appearance (twice).
|
During surgery
|
|
Ease of Insertion
Time Frame: During surgery
|
Graded as 1 (success on first attempt, no resistance), 2 (success on first, with resistance), 3 (success after >1 attempt).
|
During surgery
|
|
Operator Complications
Time Frame: Post-surgery up to 24 hours
|
Incidence of sore throat, laryngospasm, voice hoarseness, dysphagia.
|
Post-surgery up to 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 17, 2025
Primary Completion (Actual)
June 23, 2026
Study Completion (Actual)
June 23, 2026
Study Registration Dates
First Submitted
August 9, 2025
First Submitted That Met QC Criteria
August 9, 2025
First Posted (Actual)
August 15, 2025
Study Record Updates
Last Update Posted (Actual)
July 10, 2026
Last Update Submitted That Met QC Criteria
July 8, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DUIH 2025-04-012-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will be managed confidentially and stored for 3 years post-study, then destroyed per privacy laws.
No sharing planned.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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