UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050120 |
|---|---|
| Receipt number | R000040743 |
| Scientific Title | The change of resipratory and hemodynamic change with recruitment. |
| Date of disclosure of the study information | 2023/01/24 |
| Last modified on | 2023/01/24 15:49:07 |
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Basic information
Public title
The change of resipratory and hemodynamic change with recruitment.
Acronym
The change of resipratory with recruitment.
Scientific Title
The change of resipratory and hemodynamic change with recruitment.
Scientific Title:Acronym
The change of resipratory with recruitment.
Region
| Japan |
Condition
Condition
Pediatric patients (ASA-PS: 1-2; aged 3 months to 10 years) who underwent general anesthesia for elective dental or oral surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the effects of RM followed by PEEP on VT, respiratory function, and hemodynamics in pediatric patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
effects of RM followed by PEEP on VT, respiratory function, and hemodynamics in pediatric patient
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
| 3 | months-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pediatric patients (ASA-PS: 1-2; aged 3 months to 10 years) who underwent general anesthesia for elective dental or oral surgery
Key exclusion criteria
Patients with upper respiratory tract or preoperative lung disease were excluded from the study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | MASANORI |
| Middle name | |
| Last name | TSUKAMOTO |
Organization
Kyushu University Hospital
Division name
Department of Dental Anesthesiology
Zip code
8140003
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
0926426480
tsuqamoto@gmail.com
Public contact
Name of contact person
| 1st name | MASANORI |
| Middle name | |
| Last name | TSUKAMOTO |
Organization
Kyushu University Hospital
Division name
Department of Dental Anesthesiology
Zip code
8140003
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
0926426840
Homepage URL
tsuqamoto@gmail.com
Sponsor or person
Institute
kyushu university hospital
Institute
Department
Personal name
Funding Source
Organization
kyushu University hospital
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
Kyushu university hospital
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel
0926426480
tm10271980@yahoo.co.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
| 2023 | Year | 01 | Month | 24 | 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
60
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
| 2019 | Year | 01 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not applicable
Management information
Registered date
| 2023 | Year | 01 | Month | 24 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040743
