UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062723 |
|---|---|
| Receipt number | R000071811 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/08/28 13:09:08 |
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Basic information
Public title
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
Acronym
AI-assisted Channel-VL Intubation Time RCT in Novices
Scientific Title
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
Scientific Title:Acronym
AI-assisted Channel-VL Intubation Time RCT in Novices
Region
| Japan |
Condition
Condition
Patients undergoing elective surgery requiring endotracheal intubation under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcome Name: Time to Intubation (TTI)
Definition: Time elapsed (in seconds) from the passage of the video laryngoscope blade through the dental arch until the first ring mark on the endotracheal tube passes between the vocal folds (confirmed by capnography ETCO2 waveform).
Timepoint: During the intubation procedure (each case)
Key secondary outcomes
1. First-Pass Success (FPS) Rate: Proportion of successful endotracheal intubation achieved on the first blade insertion without direct physical assistance or manual intervention by the attending physician. [Timepoint: Immediately after each attempt]
2. Percentage of Glottic Opening (POGO) Score: Visualized percentage of the glottic opening . [Timepoint: During the intubation procedure]
3. Frequency of Attending Physician Verbal Advice: Number of standardized verbal cues or instructions provided by the attending physician during the attempt. [Timepoint: During each attempt]
4. Perioperative Complication Rate: Incidence of hypoxemia (SpO2 less than 93 percent), dental injury, oral bleeding, or esophageal intubation. [Timepoint: From the end of intubation until extubation or PACU admission]
5. Learning Curve: Changes in time to intubation (TTI) across consecutive intubation attempts (1st to 6th cases per resident) and the interaction between AI assistance and consecutive attempt order (AI x attempt number). [Timepoint: During data analysis after completion of all cases]
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
132
Research contact person
Name of lead principal investigator
| 1st name | Takahiko |
| Middle name | |
| Last name | Asano |
Organization
GIFU PREFECTURAL GENERAL MEDICAL CENTER
Division name
Anesthesiology
Zip code
500-8717
Address
4-6-1 Noishiki, Gifu, Gifu 500-8717, Japan
TEL
+81-58-246-1111
takahiko_1989@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takahiko |
| Middle name | |
| Last name | Asano |
Organization
GIFU PREFECTURAL GENERAL MEDICAL CENTER
Division name
Anesthesiology
Zip code
500-8717
Address
4-6-1 Noishiki, Gifu, Gifu 500-8717, Japan
TEL
+81-58-246-1111
Homepage URL
takahiko_1989@yahoo.co.jp
Sponsor or person
Institute
GIFU PREFECTURAL GENERAL MEDICAL CENTER
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu Prefectural General Medical Center
Address
4-6-1 Noishiki, Gifu, Gifu 500-8717, Japan
Tel
+81-58-246-1111
takahiko_1989@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 28 | Day |
Last modified on
| 2026 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071811
