Tokyo, Feb. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060655) titled 'Comparison of Leak Pressure and Ventilation Performance Between i-gel and i-gel PLUS in Anesthetized Adults: A Randomized Controlled Trial Including Neck Flexion Angle' on Feb. 12.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Seirei Mikatahara General Hospital

Condition: Condition - Patients aged 20 years or older undergoing general anesthesia who require airway management Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To compare oropharyngeal leak pressure (OPLP) and ventilatory performance (peak inspiratory pressure, tidal volume, ventilation score) between conventional i-gel and new i-gel PLUS in anesthetized adults, accounting for differences in neck flexion angle. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Assign and insert either the supraglottic airway device i-gel or i-gel PLUS. Interventions/Control_2 - Set the head and neck angle in the following three stages: neutral position, mild flexion (15 degrees), mild extension (15 degrees) Measure the angle using a goniometer

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Patients aged 20 years or older undergoing general anesthesia who require airway management Patients for whom informed consent was obtained through their signature on the consent form for participation in this study Key exclusion criteria - Refusal to participate in the study Same-day surgery Existing neurological or cognitive impairment Use of antipsychotic medications BMI (body mass index) exceeding 35 kg/m2 or body weight exceeding 90 kg Mouth opening less than 2.5 cm Acute sore throat Conditions with risk of aspiration (e.g., pregnancy, gastroesophageal reflux disease, hiatal hernia) History of difficult intubation Limited neck mobility (e.g., atlantoaxial subluxation, history of cervical spine or head/neck surgery) Target Size - 40

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 01 Month 30 Day Date of IRB - 2026 Year 01 Month 30 Day Anticipated trial start date - 2026 Year 02 Month 12 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069378

Disclaimer: Curated by HT Syndication.