UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000043781 |
|---|---|
| Receipt number | R000049969 |
| Scientific Title | PTT (pulse transit time) for hypertensive patients Usefulness of blood pressure fluctuation prediction |
| Date of disclosure of the study information | 2023/03/24 |
| Last modified on | 2021/03/30 19:56:50 |
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Basic information
Public title
PTT (pulse transit time) for hypertensive patients Usefulness of blood pressure fluctuation prediction
Acronym
PTT (pulse transit time) for hypertensive patients Usefulness of blood pressure fluctuation prediction
Scientific Title
PTT (pulse transit time) for hypertensive patients Usefulness of blood pressure fluctuation prediction
Scientific Title:Acronym
PTT (pulse transit time) for hypertensive patients Usefulness of blood pressure fluctuation prediction
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Anesthesiology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy of PTT as blood pressure fluctuation prediction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To disseminate PTT as an additional method to respond without delay on blood pressure change.
Key secondary outcomes
To provide more safer management on Monitored Anesthesia Care (MAC)
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
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
| Device,equipment |
Interventions/Control_1
monitoring device: 3 LED ECG patch attached at patient according to color and designated location of the patch, NIBP cuff at left arm and SpO2 clip on right index finger.
API/AVI measurement device: NIBP cuff at right arm.
first 5 minutes will be recorded as baseline/control.
Data recording
1.after reaching BIS range 70-80
2.5 minutes after Local anesthesia administered
3.30 minutes after the start of surgery
4.After patient awakened
5.After venous line removed
6.Patient back into seating position
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects are Adult undergoing dental treatment with intravenous sedation who has a history of hypertension and adult cases with high blood pressure during the visit.
AHA physical status I-II.
Key exclusion criteria
cerebral palsy
post brain aneurysm quadriplegia
shunt for hemodialysis
post breast cancer surgery with axilla lymph node dissection
taking Beta-blocker drug
neuromuscular disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hilmanda |
| Middle name | |
| Last name | Hilmanda |
Organization
Graduate School of Dental Science, Tokyo Medical and Dental University
Division name
Anesthesiolgy and Orofacial Pain Management
Zip code
1138549
Address
Tokyo, Bunkyo-Ku, Yushima 1-5-45
TEL
03-5803-5549
hilmanph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hilmanda |
| Middle name | |
| Last name | Hilmanda |
Organization
Graduate School of Dental Science, Tokyo Medical and Dental University
Division name
Anesthesiolgy and Orofacial Pain Management
Zip code
1138549
Address
Tokyo, Bunkyo-Ku, Yushima 1-5-45
TEL
03-5803-5549
Homepage URL
hilmanph@tmd.ac.jp
Sponsor or person
Institute
Anesthesiology and Orofacial Pain Management Department, Graduate School of Dental Science, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Anesthesiology and Orofacial Pain Management Department, Graduate School of Dental Science, Tokyo Medical and Dental 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
School of Dentistry Ethics Review Committee
Address
Tokyo, Bunkyo-Ku, Yushima 1-5-45 (TMDU Dental Hospital)
Tel
03-5803-5404
d-hyoka.adm@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
| 2023 | Year | 03 | Month | 24 | 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
| 2021 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049969
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
