UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048822 |
|---|---|
| Receipt number | R000055585 |
| Scientific Title | The Potential of esCCO to Predict Blood Pressure Variability during Dental Treatment |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2022/09/01 20:46:33 |
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Basic information
Public title
The Potential of esCCO to Predict Blood Pressure Variability during Dental Treatment
Acronym
The Potential of esCCO to Predict Blood Pressure Variability during Dental Treatment
Scientific Title
The Potential of esCCO to Predict Blood Pressure Variability during Dental Treatment
Scientific Title:Acronym
The Potential of esCCO to Predict Blood Pressure Variability during Dental Treatment
Region
| Japan |
Condition
Condition
Dental caries
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Detection of blood pressure variation by a new parameter esCCO that allows continuous measurement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference between esCCO-triggered manual blood pressure measurements and intermittent automatic blood pressure measurements
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Manual blood pressure measurement triggered by esCCO changes that occur within 5 minutes after the local anesthetic injection.
Interventions/Control_2
Manual blood pressure measurement in case of intraoperative esCCO changes
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults or adults with only well-controlled hypertension between 18 and 65 years old who are scheduled for dental treatment under intravenous sedation
Key exclusion criteria
Cardiovascular diseases other than hypertension, cerebrovascular, respiratory, hepatic, renal and psychiatric diseases, in addion to diabetes mellitus.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Wakita |
Organization
Tokyo Medical and Dental University
Division name
Dental Anesthesiology and Orofacial Pain Medicine
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
0358035549
ryoanph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Wakita |
Organization
Tokyo Medical and Dental University
Division name
Dental Anesthesiology and Orofacial Pain Medicine
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
0358035549
Homepage URL
ryoanph@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethic Committee of Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
0358035404
d-hyoka.adm@cmn.tmd.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
| 2022 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 10 | Month | 03 | 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
Management information
Registered date
| 2022 | Year | 09 | Month | 01 | Day |
Last modified on
| 2022 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055585
