UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045699 |
|---|---|
| Receipt number | R000052162 |
| Scientific Title | Determination of respiratory sound in the lateral position by continuous respiratory sound monitoring. |
| Date of disclosure of the study information | 2021/10/08 |
| Last modified on | 2022/04/28 16:05:38 |
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Basic information
Public title
Determination of respiratory sound in the lateral position by continuous respiratory sound monitoring.
Acronym
Determination of respiratory sound in the lateral position by continuous respiratory sound monitoring.
Scientific Title
Determination of respiratory sound in the lateral position by continuous respiratory sound monitoring.
Scientific Title:Acronym
Determination of respiratory sound in the lateral position by continuous respiratory sound monitoring.
Region
| Japan |
Condition
Condition
Patient undergoing surgery in the lateral position.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether it is possible to determine whether and to what extent atelectasis occurs in the lateral position by continuous respiratory sound monitoring.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection of left-right difference in respiratory sound in the lateral position.
Key secondary outcomes
Detection of changes in respiratory sound in alveolar recruitment.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who, after receiving sufficient explanation and understanding, have given written consent of their own free will to participate in this research.
Key exclusion criteria
Patients whose consent was not obtained.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Michiyoshi |
| Middle name | |
| Last name | Sanuki |
Organization
National Hospital Organization Kure-Medical Center Chugoku Cancer Center
Division name
Department of Anesthesiology, Critical Care and Pain Medicine
Zip code
737-0023
Address
3-1, Aoyamacho, Kure, Hiroshima, Japan
TEL
0823223111
msanuki@ff.iij4u.or.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Muraoka |
Organization
National Hospital Organization Kure-Medical Center Chugoku Cancer Center
Division name
Department of Anesthesiology, Critical Care and Pain Medicine
Zip code
737-0023
Address
3-1, Aoyamacho, Kure, Hiroshima, Japan
TEL
0823223111
Homepage URL
t.snow.chami@icloud.com
Sponsor or person
Institute
National Hospital Organization Kure-Medical Center Chugoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board at Kure Medecal Center
Address
3-1, Aoyamacho, Kure, Hiroshima, Japan
Tel
0823223111
yokoo.reina.gs@mail.hosp.go.jp
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 08 | 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
| 2021 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non
Management information
Registered date
| 2021 | Year | 10 | Month | 07 | Day |
Last modified on
| 2022 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052162
