UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039039 |
|---|---|
| Receipt number | R000044521 |
| Scientific Title | Optimal site of precordial stethoscope for un-intubated children |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2020/12/21 12:50:48 |
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Basic information
Public title
Acoustic evaluation of differences in auscultation sound among auscultation site after extubation in pediatric anesthesia patients
Acronym
Evaluation of auscultation sound after extubation in pediatric anesthesia patient
Scientific Title
Optimal site of precordial stethoscope for un-intubated children
Scientific Title:Acronym
precordial stethoscope for children
Region
| Japan |
Condition
Condition
Children under 2 years after extubation for general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the optimal site of stethoscope for listening to breath sounds for children under 2 years of age.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clarity of breath sounds at the auscultation site. That are six parts such as the side neck, the upper sternal notch, the upper chest, the lower chest, the lateral chest and the epigastric area.
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
| 2 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) <2 years of age
2) receive general anesthesia
Key exclusion criteria
1) emergency surgery
2) patients without enough space for stethoscope attachment
3) patients with skeletal abnormalities from head to cheek
4) patients with excitement after extubation (RASS> 0)
*RASS: Richmond Agitation-Sedation Scale
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hidekazu |
| Middle name | |
| Last name | Ito |
Organization
Aichi Developmental Disability Center Central Hospital
Division name
Department of Anesthesiology
Zip code
480-0392
Address
713-8 Kagiya-cho, Kasugai-city, Aichi 480-0392, Japan
TEL
0568880811
oniheizo1745@gmail.com
Public contact
Name of contact person
| 1st name | Hidekazu |
| Middle name | |
| Last name | Ito |
Organization
Aichi Developmental Disability Center Central Hospital
Division name
Department of Anesthesiology
Zip code
480-0392
Address
713-8 Kagiya-cho, Kasugai-city, Aichi 480-0392, Japan
TEL
0568880811
Homepage URL
oniheizo1745@gmail.com
Sponsor or person
Institute
Aichi Developmental Disability Center Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Developmental Disability Center Central Hospital
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
Aichi Developmental Disability Center Central Hospital
Address
713-8 Kagiya-cho, Kasugai-city, Aichi 480-0392, Japan
Tel
0568880811
oniheizo1745@gmail.com
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
愛知県医療療育総合センター中央病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Clarity of breath sounds at the auscultation site. That are six parts such as the side neck, the upper sternal notch, the upper chest, the lower chest, the lateral chest and the epigastric area.
Management information
Registered date
| 2019 | Year | 12 | Month | 31 | Day |
Last modified on
| 2020 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044521
