UMIN-CTR Clinical Trial

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
Email	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
Email	hilmanph@tmd.ac.jp

Sponsor
Institute	Anesthesiology and Orofacial Pain Management Department, Graduate School of Dental Science, Tokyo Medical and Dental University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049969