UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060409 |
|---|---|
| Receipt number | R000069085 |
| Scientific Title | Evaluation of Continuous Noninvasive Blood Pressure Monitoring Compared With Invasive Arterial Blood Pressure: An Error Grid Analysis |
| Date of disclosure of the study information | 2026/01/20 |
| Last modified on | 2026/01/20 13:36:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of Continuous Noninvasive Blood Pressure Monitoring Compared With Invasive Arterial Blood Pressure: An Error Grid Analysis
Acronym
Evaluation of Continuous Noninvasive Blood Pressure Monitoring Compared With Invasive Arterial Blood Pressure: An Error Grid Analysis
Scientific Title
Evaluation of Continuous Noninvasive Blood Pressure Monitoring Compared With Invasive Arterial Blood Pressure: An Error Grid Analysis
Scientific Title:Acronym
Evaluation of Continuous Noninvasive Blood Pressure Monitoring Compared With Invasive Arterial Blood Pressure: An Error Grid Analysis
Region
| Japan |
Condition
Condition
Patients who underwent general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will compare blood pressure values obtained with the noninvasive blood pressure monitor, the VitaWave finger cuff, with invasive arterial pressure measured via a radial arterial catheter in elective surgical patients undergoing general anesthesia , using error grid analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In this study, we will compare blood pressure values obtained with the noninvasive blood pressure monitor, the VitaWave finger cuff, with invasive arterial pressure measured via a radial arterial catheter in elective surgical patients undergoing general anesthesia , using error grid analysis.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing surgery under general anesthesia in the supine position.
2. Patients for whom intraoperative invasive arterial blood pressure monitoring is required as part of standard blood pressure monitoring.
Key exclusion criteria
1. Emergency surgery.
2. Known preoperative arrhythmias, such as atrial fibrillation.
3. Patients in whom blood pressure measurement on both arms is difficult (e.g., post-breast cancer surgery, hemodialysis patients).
4. A preoperative inter-arm blood pressure difference of > 10 mmHg in mean arterial pressure.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Juri |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
5458586
Address
1-5-7 Asahimachi, Abenoku, Osaka City, Osaka, Japan
TEL
0666452186
takataka0061@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Juri |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
5458586
Address
1-5-7 Asahimachi, Abenoku, Osaka City, Osaka, Japan
TEL
0666452186
Homepage URL
takataka0061@yahoo.co.jp
Sponsor or person
Institute
Osaka Metropolitan University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Osaka Metropolitan University Graduate School of Medicine Ethics committee
Address
1-5-7,Asahimachi, Abenoku, Osaka City, Osaka, Japan
Tel
0666456125
ethics@med.osaka-cu.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
| 2026 | Year | 01 | Month | 20 | 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
| 2025 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we will compare blood pressure measurements obtained with the noninvasive blood pressure monitor VitaWave Finger Cuff with invasive arterial pressure measured via a radial arterial catheter in patients undergoing elective surgery under general anesthesia in whom invasive arterial blood pressure monitoring is required, using error grid analysis.
Management information
Registered date
| 2026 | Year | 01 | Month | 20 | Day |
Last modified on
| 2026 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069085
