UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038479
Receipt number 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 12:59:18

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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 or person

Institute

Aichi Developmental Disability Center

Institute

Department

Personal name



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

Value
https://center6.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