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Japanese

Feb. 14, 2025

Jan. 28, 2026

jRCT1042240192

Comparative Study of the Effect of the New and Old i-gel Supraglottic Device on Airway Management in the Lateral Supine Position

Comparison of the effect of the use of the i-gel, a supraglottic device, on airway clearance and effectiveness in patients in the lateral position.

Kawashima Shingo

Hamamatsu University School of Medicine

1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka

+81-534352286

shingogo@hama-med.ac.jp

Kawashima Shingo

Hamamatsu University School of Medicine

1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka

+81-9099478196

shingogo@hama-med.ac.jp

Pending

Feb. 14, 2025

100

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

other

Participants scheduled for surgical treatment under routine clinical practice between August 2024 and March 2026 at Hamamatsu University Hospital, Seirei Mikatahara General Hospital, and Hidaka Hospital were screened for eligibility. Patients who met all of the following criteria were included:

Patients aged 20 years or older.
Patients undergoing general anesthesia with neuromuscular blocking agents for scheduled surgery requiring approximately two hours in the lateral position.
Patients who provided written informed consent indicating voluntary participation in this study.

Patients who meet any of the following criteria are not eligible for this study
1. Patients for whom intubation is clinically indicated due to severe obesity or severely compromised respiratory function.
2. Patients in whom the administration of muscle relaxants is inappropriate or unnecessary for the performance of general anesthesia or surgery.
3. Patients for whom induction of anesthesia with intravenous anesthetics (propofol or midazolam) is considered inappropriate.

20age old over
No limit

Both

Patients scheduled for surgery and induction of general anesthesia with muscle relaxants

Allocation to igel group and igel plus group

We evaluated leak pressure, expiratory tidal volume, and glottic view during mechanical ventilation in the supine and lateral positions using the i-gel and i-gel Plus.

i-gel information: size, insertion time, number of insertions, insertion status index, and number of size changes
Information after i-gel extubation: blood adherence, postoperative hoarseness, postoperative dysphagia, postoperative dysphonia, and intubation transition.
Background of the subject: age, gender, smoking history, lung disease history, sleep apnea history, cervical spine lesion history, respiratory status interview including presence or absence of snoring, and surgical procedure.
Physical examination: Height, weight, dental condition, and head and neck condition, including degree of aperture,
Clinical examination (within the scope of the preoperative examination): pulmonary function tests (lung capacity, rate per second),

Intersurgical
Clinical Research Review Committee, Hamamatsu University School of Medicine, National University Corporation
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka, Shizuoka

+81-53-435-2680

kenkyou.s@hama-med.ac.jp
Approval

Oct. 22, 2024

No

none

History of Changes

No Publication date
3 Jan. 28, 2026 (this page) Changes
2 Jan. 26, 2026 Detail Changes
1 Feb. 14, 2025 Detail