UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047351 |
|---|---|
| Receipt number | R000054007 |
| Scientific Title | Risk factors associated with respiratory adverse events during securing airway in children |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/04/04 08:43:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Risk factors for respiratory adverse events during general anesthesia in children
Acronym
Risks for respiratory adverse events during general anesthesia in children
Scientific Title
Risk factors associated with respiratory adverse events during securing airway in children
Scientific Title:Acronym
Risks associated with respiratory adverse events during securing airway in children
Region
| Japan |
Condition
Condition
Not specific
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the incidence rate of respiratory adverse events during securing airway during anesthesia induction in children, and associated risk factors regarding anesthesia, anesthesia provider, and patient.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of respiratory adverse events (dichotomous outcome)
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients aged <18 years old who received general anesthesia or sedation for surgery, procedure, or examination by anesthesia providers.
2. Initial case for airway management during the study period
Key exclusion criteria
1. Airway management was performed in intensive care units (NICU, PICU, CICU) or Emergency department
2. Anesthesia providers were consult for airway securing outside operating suites
3. Patient or Patient's family refused to be
enrolled into the research
4. Duplicated cases
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | TAIKI |
| Middle name | |
| Last name | KOJIMA |
Organization
Aichi Children's Health and Medical Center
Division name
Anesthesiology
Zip code
4748710
Address
Obu city Morioka-cho 7-426, Aichi, Japan
TEL
0562-43-0500
daiki_kojima@sk00106.achmc.pref.aichi.jp
Public contact
Name of contact person
| 1st name | TAIKI |
| Middle name | |
| Last name | KOJIMA |
Organization
Aichi Children's Health and Medical Center
Division name
Anesthesiology
Zip code
4748710
Address
Obu city Morioka-cho 7-426, Aichi, Japan
TEL
0562-43-0500
Homepage URL
daiki_kojima@sk00106.achmc.pref.aichi.jp
Sponsor or person
Institute
Aichi Children's Health and Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Aichi Children's Health and Medical Center
Address
Obu city Morioka-cho 7-426, Aichi, Japan
Tel
0562430500
daiki_kojima@sk00106.achmc.pref.aichi.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
| 2022 | Year | 04 | 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
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054007
