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Completed

NCT Number: NCT07125677

Comparison of I-gel and I-gel Plus in Elderly Patients

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.

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Key information

Conditions

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

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dongguk University Ilsan Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Fixation Stability

    Time frame: During surgery

    Assessment of device position maintenance after insertion (device movement yes/no).

  2. Time to Successful Insertion

    Time frame: During surgery

    Time from start of insertion to complete EtCO2 curve appearance (twice).

  3. 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).

  4. Operator Complications

    Time frame: Post-surgery up to 24 hours

    Incidence of sore throat, laryngospasm, voice hoarseness, dysphagia.

Sponsors and collaborators

Lead sponsor

Dongguk University International Hospital

Other

Registry information

Official study title

Comparison of Airway Sealing Pressure Between I-gel® and I-gel Plus® in Elderly Patients Under General Anesthesia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.