臨床研究等提出・公開システム

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

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

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

other

Patients who will undergo induction of general anesthesia with muscle relaxants in the regular medical care at Hamamatsu University Hospital between August 2024 and March 2026.

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.

Both

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

Allocation to igel group and igel plus group

i-gel information: size, insertion time, number of insertions, insertion status index, and number of size changes
Leak pressure, expiratory volume, and glottal findings during ventilation (see figure below)
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), biochemical tests (AST (GOT), ALT (GPT), LDH, ALP, cholinesterase, LAP, gamma-GTP, amylase, BNP, urea nitrogen, creatinine, CRP)

Assess leak pressure, expiratory volume, and glottal findings during ventilation in the supine position with the i-gel and i-gel plus.

+81-53-435-2680

Oct. 22, 2024

No

none