Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
43 participants
INTERVENTIONAL
2025-11-17
2026-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Group I
Patients receive I-gel® first, followed by removal and insertion of I-gel plus®.
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.
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.
Group P
Patients receive I-gel plus® first, followed by removal and insertion of I-gel®.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Scheduled for elective surgery under general anesthesia lasting less than 3 hours.
Exclusion Criteria
* 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.
65 Years
85 Years
ALL
No
Sponsors
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Dongguk University International Hospital
OTHER
Responsible Party
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Hansu Bae
Assistant professor
Locations
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Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DUIH 2025-04-012-003
Identifier Type: -
Identifier Source: org_study_id
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