UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026881 |
|---|---|
| Receipt number | R000030819 |
| Scientific Title | Examination of the breathing circulation state monitoring in the dental treatment under vein anesthesia or the intravenous sedation with the breathing heartbeat monitoring mat |
| Date of disclosure of the study information | 2017/04/05 |
| Last modified on | 2017/04/05 21:49:41 |
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Basic information
Public title
Examination of the breathing circulation state monitoring in the dental treatment under vein anesthesia or the intravenous sedation with the breathing heartbeat monitoring mat
Acronym
Examination of the breathing circulation state monitoring in the dental treatment with the breathing heartbeat monitoring mat
Scientific Title
Examination of the breathing circulation state monitoring in the dental treatment under vein anesthesia or the intravenous sedation with the breathing heartbeat monitoring mat
Scientific Title:Acronym
Examination of the breathing circulation state monitoring in the dental treatment with the breathing heartbeat monitoring mat
Region
| Japan |
Condition
Condition
Dental phobia Mental retardation
Classification by specialty
| Dental medicine | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I inspect whether a Aortic pulse wave is effective for the breathing circulation ventilation index in the dental treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Aortic pulse wave
Key secondary outcomes
Arterial oxygen saturation
Blood pressure
Heart rate
Bispectral Index
Richmond agitation sedation scale
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We intend for the patient who performs dental treatment or oral surgery minor surgery and is ASA classification I, II case.
Key exclusion criteria
The past of sleep apnea syndrome
Cerebral palsy patient
ASA 3 over
BMI 35 over
Mallampati classification 3 over
The distance between the thyroid cartilagefrom a chin 6cm under
The patient whom researchers judged inappropriate is exclusion.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Ayuse |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Dental Anesthesiology
Zip code
Address
1-7-1, Sakamoto, Nagasaki-shi, Nagasaki
TEL
095-819-7714
ayuse@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensuke Kiriishi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Dental Anesthesiology
Zip code
Address
1-7-1, Sakamoto, Nagasaki-shi, Nagasaki
TEL
095-819-7714
Homepage URL
kiriishi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
Address
Tel
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
| 2017 | Year | 04 | Month | 05 | 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
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
I inspect whether a Aortic pulse wave is effective for the breathing circulation ventilation index in the dental treatment.
Management information
Registered date
| 2017 | Year | 04 | Month | 05 | Day |
Last modified on
| 2017 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030819
