UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040822 |
|---|---|
| Receipt number | R000046601 |
| Scientific Title | Evaluation of respiratory sound and noise with dental instruments using sound monitoring. |
| Date of disclosure of the study information | 2020/06/18 |
| Last modified on | 2024/12/03 19:01:33 |
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Basic information
Public title
Evaluation of respiratory sound and noise with dental instruments using sound monitoring.
Acronym
Evaluation of respiratory sound and noise with dental instruments using sound monitoring.
Scientific Title
Evaluation of respiratory sound and noise with dental instruments using sound monitoring.
Scientific Title:Acronym
Evaluation of respiratory sound and noise with dental instruments using sound monitoring.
Region
| Japan |
Condition
Condition
Patients who receive dental treatment
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify to better understand the special acoustic characteristics necessary for accurate respiratory condition monitoring during dental sedation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Feasibility of respiratory sound monitoring during dental treatment.
1) respiratory sound
2) noise with dental instrument
Key secondary outcomes
Comparison of existing respiratory sound monitoring systems
1) vs chest wall observation
2) vs capnograph monitoring
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who receive dental treatment with informed consent.
Key exclusion criteria
Patients without informed consent.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Irifune |
Organization
Hiroshima University
Division name
Department of Dental Anesthesiology, Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan.
TEL
+81-82-257-5733
mirifun@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Shimizu |
Organization
Hiroshima University
Division name
Department of Dental Anesthesiology, Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan.
TEL
+81-82-257-5733
Homepage URL
yshimizu@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Hiroshima University hospital IRB
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551, Japan
Tel
+81-82-257-5596
hugcp@hiroshima-u.ac.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
広島大学病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
https://anesthesiaprogress.kglmeridian.com
Publication of results
Unpublished
Result
URL related to results and publications
https://anesthesiaprogress.kglmeridian.com
Number of participants that the trial has enrolled
30
Results
The mean intensity of dental suction sounds was significantly lower in the chest region compared with the cervicalregion, regardless of the breathing condition (P , .001). Furthermore, in the chest region, the mean sound frequency during
oral breathing was significantly lower than that during nasal breathing (P , .01).
Results date posted
| 2024 | Year | 12 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy volunteers
Participant flow
Poster Display
Adverse events
Non
Outcome measures
Dental suction noise
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 10 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
non
Management information
Registered date
| 2020 | Year | 06 | Month | 18 | Day |
Last modified on
| 2024 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046601
