UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060787 |
|---|---|
| Receipt number | R000069436 |
| Scientific Title | Predicting Pediatric Airway Morbidity with Pre-extubation Fiberoptic Laryngoscopy |
| Date of disclosure of the study information | 2026/02/28 |
| Last modified on | 2026/03/01 15:01:23 |
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Basic information
Public title
Predicting Pediatric Airway Morbidity with Pre-extubation Fiberoptic Laryngoscopy
Acronym
P-AMAFL Study
Scientific Title
Predicting Pediatric Airway Morbidity with Pre-extubation Fiberoptic Laryngoscopy
Scientific Title:Acronym
P-AMAFL Study
Region
| Japan |
Condition
Condition
post-extubation laryngeal edema
Classification by specialty
| Intensive care medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the predictive performance of pre-extubation laryngeal fiberoptic imaging for post-extubation upper airway obstruction in pediatric patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of post-extubation stridor (PES) within 60 minutes after extubation
Key secondary outcomes
National Paediatric Early Warning System (NPEWS) score within 60 minutes after extubation
Presence of chest retractions within 60 minutes after extubation
Administration of systemic corticosteroids within 60 minutes after extubation
Use of high-flow nasal cannula (HFNC) within 24 hours after extubation
Use of noninvasive ventilation (NIV) within 24 hours after extubation
Reintubation within 24 hours after extubation
Procedure-related complications (e.g., nasal bleeding, oral bleeding)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Laryngeal fiberoptic examination will be performed at the time of extubation. Two physicians will independently assess the pre-extubation laryngeal fiberoptic images using recorded videos that have been prepared so that neither patient-identifying information nor the primary outcome can be ascertained. In cases of disagreement, a final judgment will be reached by consensus after discussion.
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
| Not applicable |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Oral or nasal endotracheal intubation (either is acceptable).
2. Aged 18 years or younger.
3. Use of a cuffed endotracheal tube.
4. Written informed consent has been obtained from the patient and/or a legally authorized representative (the patient's parent/guardian).
5. Extubation is planned between 08:30 and 17:00.
(To ensure assessment quality, the procedure will be performed only during daytime hours so that multiple staff members can attend.)
6. The department conference has determined that performing laryngeal fiberoptic examination is appropriate.
Key exclusion criteria
1. Unplanned extubation (because the examination cannot be performed).
2. The examination is judged to carry a high risk due to underlying conditions or other clinical factors
(including situations in which transnasal insertion is difficult, such as after head and neck surgery).
3. History of allergy to local anesthetics.
Target sample size
116
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kanno |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Department of Pediatric Emergency and Critical Care Medicine
Zip code
6608550
Address
2-17-77, Higashi-Naniwa-cho, Amagasaki, Hyogo 660-8550, Japan
TEL
0664807000
nemurisugitakan@gmail.com
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Kanno |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Department of Pediatric Emergency and Critical Care Medicine
Zip code
6608550
Address
2-17-77, Higashi-Naniwa-cho, Amagasaki, Hyogo 660-8550, Japan
TEL
0664807000
Homepage URL
nemurisugitakan@gmail.com
Sponsor or person
Institute
Hyogo Prefectural Amagasaki General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Hyogo Prefectural Amagasaki General Medical Center
Address
2-17-77, Higashi-Naniwa-cho, Amagasaki, Hyogo 660-8550, Japan
Tel
0664807000
agmc-rinri01@hp.pref.hyogo.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 | 28 | 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 | 06 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | 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 | 02 | Month | 28 | Day |
Last modified on
| 2026 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069436
