UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060221 |
|---|---|
| Receipt number | R000068880 |
| Scientific Title | Difference Between Invasive and Non-Invasive Blood Pressure Measurements in Patients With Atrial Fibrillation Undergoing Non-Cardiac Surgery: A Prospective Observational Study Using Error Grid Analysis |
| Date of disclosure of the study information | 2025/12/29 |
| Last modified on | 2025/12/28 11:21:15 |
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Basic information
Public title
Difference Between Invasive and Non-Invasive Blood Pressure Measurements in Patients With Atrial Fibrillation Undergoing Non-Cardiac Surgery: A Prospective Observational Study Using Error Grid Analysis
Acronym
Difference Between Invasive and Non-Invasive Blood Pressure Measurements in Patients With Atrial Fibrillation Undergoing Non-Cardiac Surgery: A Prospective Observational Study Using Error Grid Analysis
Scientific Title
Difference Between Invasive and Non-Invasive Blood Pressure Measurements in Patients With Atrial Fibrillation Undergoing Non-Cardiac Surgery: A Prospective Observational Study Using Error Grid Analysis
Scientific Title:Acronym
Difference Between Invasive and Non-Invasive Blood Pressure Measurements in Patients With Atrial Fibrillation Undergoing Non-Cardiac Surgery: A Prospective Observational Study Using Error Grid Analysis
Region
| Japan |
Condition
Condition
Patients with atrial fibrillation undergoing non-cardiac surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with atrial fibrillation, significant discrepancies are likely to occur between invasive and non-invasive arterial blood pressure measurements, and the magnitude of error is reported to increase for both systolic and diastolic blood pressure. Previous studies comparing invasive and non-invasive arterial blood pressure in patients with atrial fibrillation have primarily used the Bland Altman method, which involves a simple comparison between the two measurements. Recently, an error grid analysis, a novel analytical method that incorporates the clinical risk associated with blood pressure differences, has been developed for comparing two blood pressure measurements. The aim of this study was to evaluate the differences between invasive and non-invasive arterial blood pressure in patients with atrial fibrillation using error grid analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Invasive and non-invasive arterial blood pressure
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
Patients aged 20 years or older at the time of obtaining informed consent
Patients who have provided written informed consent to participate in the study
Patients with chronic atrial fibrillation
Patients undergoing non-cardiac surgery under general anesthesia
Patients with intraoperative invasive arterial blood pressure monitoring
Key exclusion criteria
Emergency surgery cases
Cardiovascular surgery cases
Patients in whom non-invasive blood pressure measurement in both upper limbs is difficult, such as those with a history of breast cancer surgery or patients with an arteriovenous fistula for hemodialysis
Patients with a preoperative inter-arm systolic blood pressure difference of 20 mmHg or greater
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Suehiro |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
634-0063
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
06-6645-2186
suehirokoichi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Suehiro |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
634-0063
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
0666452186
Homepage URL
suehirokoichi@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology, 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
Ethics Committee of Osaka Metropolitan University Graduate School of Medicine
Address
1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586 Japan
Tel
06-6645-6125
gr-a-knky-ethics@omu.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
| 2025 | Year | 12 | Month | 29 | 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 | 15 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 29 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A comparison was performed between invasive arterial blood pressure and non-invasive arterial blood pressure measured using a cuff-based device. Student's t test and the Mann-Whitney U test were used for statistical comparisons, as appropriate. In addition, measurement error was evaluated using error grid analysis, with reference to a previous study. In error grid analysis, the plot is divided into zones A through E, with zone A representing the smallest error and subsequent zones (B to E) indicating progressively larger errors. According to the report by Saugel et al., if more than 90% of measurement points fall within zone A, the difference is considered clinically acceptable. To avoid interference between measurements, invasive and non-invasive arterial blood pressure were measured in different upper limbs in this study.
Reference: Saugel B, et al. Anesth Analg. 2018; 126: 1177-85
Management information
Registered date
| 2025 | Year | 12 | Month | 28 | Day |
Last modified on
| 2025 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068880
