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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038479
Receipt No. R000043848
Scientific Title Acoustical evaluation of auscultatory sounds by auscultation sites in pediatric anesthesia patients
Date of disclosure of the study information 2020/03/31
Last modified on 2020/12/21

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Basic information
Public title Acoustical evaluation of auscultatory sounds by auscultation sites in pediatric anesthesia patients
Acronym Auscultatory sounds during pediatric anesthesia
Scientific Title Acoustical evaluation of auscultatory sounds by auscultation sites in pediatric anesthesia patients
Scientific Title:Acronym Auscultatory sounds during pediatric anesthesia
Region
Japan

Condition
Condition intubated pediatric patients undergoing general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the optimal auscultation site for respiratory sounds of intubated pediatric patients undergoing general anesthesia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of easiness of hearing breath sounds, recorded at each site, by operating room nurses
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Change of auscultation site
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 Children under 2 years performed general anesthesia with tracheal intubation
Key exclusion criteria Emergency case
Patients without enough space for stethoscope attachment
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
Division name Department of Anesthesiology
Zip code 480-0392
Address 713-8 Kagiya-cho, Kasugai-city, Aichi 480-0392, Japan
TEL 0568-88-0811
Email oniheizo1745@gmail.com

Public contact
Name of contact person
1st name Hidekazu
Middle name
Last name Ito
Organization Aichi Developmental Disability Center
Division name Department of Anesthesiology
Zip code 480-0392
Address 713-8 Kagiya-cho, Kasugai-city, Aichi 480-0392, Japan
TEL 0568-88-0811
Homepage URL
Email oniheizo1745@gmail.com

Sponsor
Institute Aichi Developmental Disability Center
Institute
Department

Funding Source
Organization Aichi Developmental Disability Center
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 Aichi Developmental Disability Center
Address 713-8 Kagiya-cho, Kasugai-city, Aichi 480-0392, Japan
Tel 0568-88-0811
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(愛知県)

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 68
Results The auscultation sound scores are shown in Figure 1. The lung sound score at Sites A,B and C were 8.0 (7.0-9.0), 4.5 (2.9-6.0) and 7.0 (5.5-8.5), respectively (Figure 1b). The heart sound scores at Site A, B and C were 3.5 (2.0-6.0), 6.5 (4.0-8.0) and, 1.0 (0.4-2.0) respectively (Figure 1c). Statistically significant differences were found in all pairs of sites (p<0.0001 except for Site A vs. C of the lung sound [p=0.0107] and Site A vs. B of the heart sound [p=0.0018]).
Results date posted
2019 Year 12 Month 31 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 12 Month 21 Day
Baseline Characteristics Regarding the demographic characteristics, there were 46 (68%) males, and the average age was 12 (6-17) months old. The median height was 72.5 (64.4-78.3) cm, weight was 8.8 (6.8-10.0) kg, and tracheal tube length was 3.5 (3.5-4.0) mm. There were 38 (56%) cases with a cuffed tracheal tube.
Participant flow
Adverse events no postoperative complications
Outcome measures operation time was 29 (23.5-43) minutes
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 08 Month 30 Day
Date of IRB
2019 Year 10 Month 21 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
2020 Year 12 Month 21 Day
Date trial data considered complete
2020 Year 12 Month 21 Day
Date analysis concluded
2020 Year 12 Month 21 Day

Other
Other related information

Management information
Registered date
2019 Year 11 Month 02 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=R000043848

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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