Tokyo, Aug. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062723) titled 'Effect of Artificial Intelligence-Assisted Channel-Type Video Laryngoscopy on Time to Intubation and Skill Acquisition among Novice Operators: A Stratified Block-Randomized Controlled Trial' on Aug. 31.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - GIFU PREFECTURAL GENERAL MEDICAL CENTER
Condition:
Condition - Patients undergoing elective surgery requiring endotracheal intubation under general anesthesia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the efficacy of a real-time artificial intelligence (AI)-assisted glottic recognition and alignment guide feature in channel-type video laryngoscopy for reducing time to intubation (TTI) among novice operators (resident physicians with 5 or fewer prior human endotracheal intubations).
Secondary objectives include assessing first-pass success rate (FPS), POGO score, frequency of attending physician verbal advice or intervention, and perioperative complications, as well as exploratorily evaluating the impact of AI assistance on the initial learning curve across consecutive intubation attempts.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Endotracheal intubation is performed using a channel-type video laryngoscope with real-time AI glottic recognition and alignment guide features enabled (ON).
Interventions/Control_2 - Endotracheal intubation is performed using a channel-type video laryngoscope with AI-assisted features disabled (OFF), displaying standard video laryngoscopy imagery.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - [Novice Operator Inclusion Criteria]
1. Resident physicians with 5 or fewer prior human endotracheal intubation experiences
2. Written informed consent obtained for participation
[Patient Inclusion Criteria]
1. Adult patients aged 18 years or older
2. Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation
3. ASA physical status 1 or 2
4. Written informed consent obtained for participation
Key exclusion criteria - [Patient Exclusion Criteria]
1. Patients requiring rapid sequence induction (e.g., full stomach, severe gastroesophageal reflux)
2. Severe respiratory or cardiovascular disease (ASA physical status 3 or higher)
3. Predicted difficult airway cases (e.g., mouth opening less than 2 cm, anatomical abnormalities, cervical spine fixation)
4. Patients deemed inappropriate for study inclusion by the principal investigator or attending physician
Target Size - 132
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 28 Day
Date of IRB - 2026 Year 07 Month 31 Day
Anticipated trial start date - 2026 Year 08 Month 31 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071811
Disclaimer: Curated by HT Syndication.
