UMIN-CTR Clinical Trial

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