Tokyo, Feb. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059553) titled 'Comparison of the Effectiveness of Mandibular Elevation Technique and Conventional Method in i-gel Insertion: A Randomized Controlled Trial' on Feb. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Active

Primary Sponsor: Institute - Seirei Mikatahara General Hospital

Condition: Condition - Patients Under General Anesthesia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The significance of this study is to reduce ventilation failure and the need for intubation due to insertion failure, thereby improving the safety of anesthesia management. From an educational perspective, establishing a reproducible technique for beginners is important. Verifying the usefulness of the mandibular elevation method as an alternative to the standard method may contribute to future anesthesia education and clinical guideline revisions. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - During insertion, the i-gel is inserted while lifting the mandible along with the tongue using one hand to create space in the oral cavity. Interventions/Control_2 - Without rotating the head, the i-gel is inserted in the sniffing position by pushing the patient's chin forward to open the mouth, and advancing it along the hard palate into the oral cavity.

Eligibility: Age-lower limit - 50 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 50 years or older undergoing general anesthesia who require airway management. Patients who provided consent to participate in this study by signing a written informed consent form. [Justification] Since insertion difficulties with the i-gel are rare in younger individuals, the age criterion was set at 50 years or older. Key exclusion criteria - Refusal to participate in the study Day surgery Pre-existing neurological or cognitive disorders Use of antipsychotic medications Body mass index (BMI) over 35 kg/m2 or body weight over 90 kg Mouth opening less than 2.5 cm Acute sore throat Conditions with a 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 and neck surgery) Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 22 Day Anticipated trial start date - 2025 Year 10 Month 22 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068118

Disclaimer: Curated by HT Syndication.