UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055966 |
|---|---|
| Receipt number | R000062733 |
| Scientific Title | Risk factors for perioperative respiratory adverse events in children. |
| Date of disclosure of the study information | 2024/10/29 |
| Last modified on | 2025/05/14 19:29:04 |
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Basic information
Public title
Risk factors for perioperative respiratory adverse events in children.
Acronym
Risk factors for perioperative respiratory adverse events in children.
Scientific Title
Risk factors for perioperative respiratory adverse events in children.
Scientific Title:Acronym
Risk factors for perioperative respiratory adverse events in children.
Region
| Japan |
Condition
Condition
perioperative respiratory adverse events
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate risk factors for perioperative extubation-related respiratory adverse events.
Basic objectives2
Others
Basic objectives -Others
The goal is to contribute to the improvement of the quality and safety of anesthesia and perioperative management.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
perioperative extubation-related respiratory adverse events
Key secondary outcomes
Interventions performed for complications, adverse events other than respiratory complications, and minimum oxygen saturation after extubation
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 | days-old | <= |
Age-upper limit
| 7 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients under 7 years of age undergoing general anesthesia
Key exclusion criteria
(1) Patients with tracheostomy
(2) Patients scheduled for postoperative intubation
(3) Patients who could not give consent to participate in the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Okuyama |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology, Pain and Palliative Medicine
Zip code
2608677
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
adha5595@chiba-u.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Okuyama |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology, Pain and Palliative Medicine
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
Homepage URL
adha5595@chiba-u.jp
Sponsor or person
Institute
Chiba University
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
Chiba University Hospital Observational Research Office
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
0432227171
adha5595@chiba-u.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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 29 | 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
112
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Prospective cohort study
The following clinical information will be collected from medical records and anesthesia records.
A) Patient background (age, sex, height, weight, birth and growth history, medical history, living environment, etc.)
B) Anesthesia-related information (operation site, operation time, anesthesia method, etc.)
C) Information on airway management at the time of induction of anesthesia (difficulty of mask ventilation, airway management route, intubation equipment, number of intubations, etc.)
D) State before and after extubation (residual anesthetic dose, state of arousal, tidal volume, end-tidal carbon dioxide concentration, etc.)
Information is collected only once during general anesthesia in routine clinical practice.
Management information
Registered date
| 2024 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062733
