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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | Patients receive I-gel® first, followed by removal and insertion of I-gel plus®. |
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| Group P | Active Comparator | Patients receive I-gel plus® first, followed by removal and insertion of I-gel®. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fixation Stability | Assessment of device position maintenance after insertion (device movement yes/no). | During surgery |
| Time to Successful Insertion | Time from start of insertion to complete EtCO2 curve appearance (twice). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguk University Ilsan Hospital | Goyang-si | Gyeonggi-do | 10323 | South Korea |
Data will be managed confidentially and stored for 3 years post-study, then destroyed per privacy laws. No sharing planned.
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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)
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No blinding is implemented.
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| 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. |
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| 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. |
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| During surgery |
| Ease of Insertion | Graded as 1 (success on first attempt, no resistance), 2 (success on first, with resistance), 3 (success after >1 attempt). | During surgery |
| Operator Complications | Incidence of sore throat, laryngospasm, voice hoarseness, dysphagia. | Post-surgery up to 24 hours |