UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057568 |
|---|---|
| Receipt number | R000065774 |
| Scientific Title | Systematic Review on the Effectiveness of Early Airway Management in Severe Midfacial Fractures |
| Date of disclosure of the study information | 2025/04/10 |
| Last modified on | 2025/04/09 16:26:22 |
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Basic information
Public title
How Can We Prevent Airway Obstruction from Facial Fractures? A Study on the Effectiveness of Early Airway Management
Acronym
Early Airway SR in Facial Fractures
Scientific Title
Systematic Review on the Effectiveness of Early Airway Management in Severe Midfacial Fractures
Scientific Title:Acronym
SR of Early Airway Management in Midfacial Fractures
Region
| Japan |
Condition
Condition
Severe midfacial fractures(Le Fort type II and III fractures, comminuted mandibular fractures, and Wish-type mandibular fractures)
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This systematic review aims to evaluate whether early airway management in patients with severe midfacial fractures improves clinical outcomes such as mortality, airway obstruction, pneumonia, ICU stay, and hospitalization compared to no intervention or observation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Airway emergency, Pneumonia, Airway obstruction or asphyxiation, Length of hospital stay, Length of ICU stay, Short-term mortality, Serious adverse events
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with severe midfacial fractures (e.g., Le Fort type II or III, comminuted mandibular fractures, or Wish-type fractures)
Key exclusion criteria
Studies not primarily focusing on severe midfacial fractures
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Hirose |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Traumatology and Acute Critical Medicine
Zip code
565-0871
Address
2-15 Yamadaoka Suita, Osaka
TEL
0668795707
htomoya1979@hp-emerg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Hirose |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Traumatology and Acute Critical Medicine
Zip code
565-0871
Address
2-15 Yamadaoka Suita, Osaka
TEL
0668795707
Homepage URL
htomoya1979@hp-emerg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
The Japanese Association for the Surgery of Trauma
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
Osaka University Graduate School of Medicine
Address
2-15 Yamadaoka Suita, Osaka
Tel
06-6879-5707
htomoya1979@hp-emerg.med.osaka-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
| 2025 | Year | 04 | Month | 10 | 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
| 2025 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a systematic review evaluating the effectiveness of early airway management in patients with severe midfacial fractures.
As this is not a clinical trial, certain fields in the UMIN form (e.g., intervention, number of groups, trial design) are completed for administrative purposes only.
The review compares early airway management versus no intervention/observation based on published studies.
Management information
Registered date
| 2025 | Year | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065774
