Tokyo, Feb. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060654) titled 'Changes in Neck Flexion Angle, Leak Pressure, and Ventilation Performance with i-ge in Anesthetized Adults' on Feb. 12.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

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 - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate oropharyngeal leak pressure (OPLP) and ventilatory performance (peak inspiratory pressure, tidal volume, ventilation score) when using the supraglottic airway device i-gel in anesthetized adults, taking into account differences in neck flexion angle. Basic objectives2 - Others

Intervention: Interventions/Control_1 - 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=R000069376

Disclaimer: Curated by HT Syndication.