UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053246 |
|---|---|
| Receipt number | R000060763 |
| Scientific Title | A study on the evaluation of upper airway obstruction during intravenous sedation in healthy adult volunteers. |
| Date of disclosure of the study information | 2023/12/28 |
| Last modified on | 2023/12/27 17:50:18 |
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Basic information
Public title
A study on the evaluation of upper airway obstruction during intravenous sedation in healthy adult volunteers.
Acronym
A study on the evaluation of upper airway obstruction during intravenous sedation in healthy adult volunteers.
Scientific Title
A study on the evaluation of upper airway obstruction during intravenous sedation in healthy adult volunteers.
Scientific Title:Acronym
A study on the evaluation of upper airway obstruction during intravenous sedation in healthy adult volunteers.
Region
| Japan |
Condition
Condition
upper airway obstruction, apnea
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
During intravenous sedation management, upper airway obstruction can occur due to the effects of anesthetic agents. Early detection and intervention are crucial if airway obstruction occurs. In our previous studies targeting patients undergoing dental treatment under intravenous sedation, we identified the potential to predict upper airway obstruction using a low-frequency specialized piezoelectric sensor (AYA-P). However, the accuracy of predicting airway obstruction in new patients using previous waveform data as training data was low, and the sample size was still insufficient. Therefore, the aim is to target healthy adult volunteers with diverse anatomical features to elucidate the correlation between anatomical characteristics and waveform patterns obtained from AYA-P, ultimately enhancing the accuracy of predicting airway obstruction in new patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Vibration velocity data
Key secondary outcomes
SpO2
EtCO2
Chest movement
Breath sounds
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administering midazolam and propofol intravenously.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adult volunteers
Key exclusion criteria
When we can not obtain the consent to study of patients and their family
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Saori |
| Middle name | |
| Last name | Takagi |
Organization
Meikai University School of Dentistry
Division name
Division of Dental Anesthesiology, Department of Diagnostic and Therapeutic Sciences
Zip code
350-0283
Address
1-1 Keyakidai, Sakado-shi, Saitama, Japan
TEL
0492792738
sogami@dent.meikai.ac.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Takagi |
Organization
Meikai University School of Dentistry
Division name
Division of Dental Anesthesiology, Department of Diagnostic and Therapeutic Sciences
Zip code
350-0283
Address
1-1 Keyakidai, Sakado-shi, Saitama, Japan
TEL
0492792738
Homepage URL
sogami@dent.meikai.ac.jp
Sponsor or person
Institute
Meikai University School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Meikai University School of Dentistry
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
Meikai University School of Dentistry
Address
1-1 Keyakidai, Sakado-shi, Saitama, Japan
Tel
0492792738
sogami@dent.meikai.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 28 | 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
| 2023 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060763
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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