Tokyo, Dec. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060221) titled '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' on Dec. 29.
Study Type:
Observational
Primary Sponsor:
Institute - Department of Anesthesiology, Osaka Metropolitan University Graduate School of Medicine
Condition:
Condition - Patients with atrial fibrillation undergoing non-cardiac surgery
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 100
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068880
Disclaimer: Curated by HT Syndication.