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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.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042240192
Enrollment
100
Registered
2025-02-14
Start date
2025-02-14
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Allocation to igel group and igel plus group

Sponsors

Kawashima Shingo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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),

Contacts

Public ContactShingo Kawashima

Hamamatsu University School of Medicine

shingogo@hama-med.ac.jp+81-9099478196

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026