UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060331 |
|---|---|
| Receipt number | R000069013 |
| Scientific Title | Exploring the Frequency and Causal Factors of Intraoral Moisture During Anesthesia Induction in Pediatric Elective Surgery: A Prospective Observational Study Using a Video Laryngoscope |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2026/01/12 17:18:44 |
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Basic information
Public title
Exploring the Frequency and Causal Factors of Intraoral Moisture During Anesthesia Induction in Pediatric Elective Surgery: A Prospective Observational Study Using a Video Laryngoscope
Acronym
Exploring the Frequency and Causal Factors of Intraoral Moisture During Anesthesia Induction in Pediatric Elective Surgery: A Prospective Observational Study Using a Video Laryngoscope
Scientific Title
Exploring the Frequency and Causal Factors of Intraoral Moisture During Anesthesia Induction in Pediatric Elective Surgery: A Prospective Observational Study Using a Video Laryngoscope
Scientific Title:Acronym
Exploring the Frequency and Causal Factors of Intraoral Moisture During Anesthesia Induction in Pediatric Elective Surgery: A Prospective Observational Study Using a Video Laryngoscope
Region
| Japan |
Condition
Condition
Pediatric patients undergoing general anesthesia for elective surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Oral secretions during anesthetic induction can impair laryngoscopic visibility and may contribute to prolonged intubation time and increased attempts. Children tend to have more oral secretions at baseline, which can further increase with crying; moreover, video laryngoscopes can lose the view when the lens is obscured by secretions, making secretion control particularly important given children's limited oxygen reserve. Routine anticholinergic premedication has become less common, yet evidence evaluating oral wet conditions in pediatric induction remains limited.
Basic objectives2
Others
Basic objectives -Others
Estimation of frequency of oral wet condition during induction and exploratory analysis of predictive factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of participants with an oral wet score >= 3. The oral wet score will be rated on a 4-point scale using recorded AceScope video at the first laryngoscopy; two board-certified anesthesiologists will independently assess the images in a blinded manner.
1 (Excellent): No secretions; very dry (no pooling in the piriform fossae, vallecula, arytenoid region, or laryngeal vestibule).
2 (Good): Slightly moist without impaired view (mild pooling/bubbles in piriform fossae or vallecula; no pooling in the arytenoid region or laryngeal vestibule).
3 (Acceptable): Moist with partial interference but suction not required (pooling/bubbles up to the arytenoid region; no pooling in the laryngeal vestibule).
4 (Poor): Very wet with obscured view requiring suction (pooling present in the laryngeal vestibule).
A score of >= 3 will be defined as wet.
Key secondary outcomes
Identification of predictive factors associated with oral wet score >= 3.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 1 | years-old | <= |
Age-upper limit
| 10 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Children aged 1 to <10 years (body weight >=5 kg)
2.Elective surgery requiring general anesthesia with tracheal intubation
3.Written informed consent obtained from a parent/guardian
Key exclusion criteria
1.Recording was not available
2.Anticipated difficult airway requiring an alternative intubation method rather than a video laryngoscope
3.Airway already secured before induction
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | TAKAYUKI |
| Middle name | |
| Last name | MORIMOTO |
Organization
Nagasaki University Hospital
Division name
Department of Anesthesiology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, JAPAN
TEL
095-819-7370
tmorimoto@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | TAKAYUKI |
| Middle name | |
| Last name | MORIMOTO |
Organization
Nagasaki University Hospital
Division name
Department of Anesthesiology
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki, JAPAN
TEL
095-819-7370
Homepage URL
tmorimoto@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.ac.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 | 02 | Month | 01 | 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 | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center, exploratory prospective observational study. Routine anesthetic induction and tracheal intubation will be performed using a recordable video laryngoscope (AceScope), and the oral cavity at the first laryngoscopy will be recorded. Postoperatively, two board-certified anesthesiologists will independently assess the recorded images under blinded conditions using a 4-grade secretion scale; a score >= 3 will be defined as "wet". The primary analysis will estimate the proportion of "wet" cases (with age-stratified estimates), and the secondary analysis will explore predictive factors using multivariable logistic regression, including patient background (e.g., history, passive smoking, fasting duration) and peri-induction/anesthetic factors (e.g., crying, induction method/position, anticholinergic use).
Management information
Registered date
| 2026 | Year | 01 | Month | 12 | Day |
Last modified on
| 2026 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069013
