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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039039
Receipt No. 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 2019/12/31

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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
Email 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
Email oniheizo1745@gmail.com

Sponsor
Institute Aichi Developmental Disability Center Central Hospital
Institute
Department

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
Email 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 Preinitiation
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 06 Month 30 Day
Date of closure to data entry
2020 Year 06 Month 30 Day
Date trial data considered complete
2020 Year 06 Month 30 Day
Date analysis concluded
2020 Year 09 Month 30 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
2019 Year 12 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044521

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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