UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055020 |
|---|---|
| Receipt number | R000062856 |
| Scientific Title | Analysis of sound elements required for risk assessment of aspiration using bioacoustic analysis. |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/02/18 15:39:48 |
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Basic information
Public title
Investigation of sound elements for aspiration risk assessment using bioacoustic analysis.
Acronym
Sound analysis required for determining the risk of aspiration.
Scientific Title
Analysis of sound elements required for risk assessment of aspiration using bioacoustic analysis.
Scientific Title:Acronym
Acoustic analysis for determining the risk of aspiration.
Region
| Japan |
Condition
Condition
Patients undergoing anaesthetic management in dental anaesthesia departments.
Classification by specialty
| Anesthesiology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In dentistry, intravenous sedation is used to relieve mental tension about treatment and to regulate excessive vomiting reflexes that interfere with treatment, and deep sedation that causes loss of consciousness increases the risk of aspiration during treatment. The risk of aspiration due to dysphagia and pharyngeal residue retention is also high after oral surgery. There are no reliable monitoring devices in these situations. Therefore, if the airway airflow can be continuously monitored using breath sound (acoustic) monitoring in this study, the risk of aspiration can be quickly identified and serious accidents and incidents can be prevented.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Index calculated by the noise discrimination model.
Key secondary outcomes
1) Fluid retention level in the upper airway. 2) Relationship between the level of fluid retention in the upper airways and surgical procedures.
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Pharyngeal suction
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing osteotomies of the maxilla and mandible.
2. Patients undergoing total intravenous anaesthesia with propofol.
3. Patients aged 18 or older at the time of consent.
Key exclusion criteria
1. Patients with an allergy or severe adverse reactions to propofol.
2. Patients with an intellectual disability.
3. Patients with a respiratory disease.
4. Patients with severe epistaxis at extubation
5. Patients with errors in the study procedure.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | non |
| 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
082-257-5733
yshimizu@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tamayo |
| Middle name | non |
| Last name | Takahashi |
Organization
Hiroshima University Hospital
Division name
Division of Dental Anaesthesiology
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5733
Homepage URL
yshimizu@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Yoshitaka Shimizu
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
Tel
082-257-5907
iryo-sinsa@office.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
| 2024 | Year | 08 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe biological sounds acquired in the cervical and chest.
Management information
Registered date
| 2024 | Year | 07 | Month | 19 | Day |
Last modified on
| 2025 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062856
