UMIN-CTR Clinical Trial

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