Tokyo, Aug. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062464) titled 'Artificial Intelligence-assisted Measurement of Cardiac Output via Non-invasive Image Technology During Passive Leg Raising Testing (AI-MONITOR): A Prospective Observational Study' on Aug. 26.

Study Type: Observational

Primary Sponsor: Institute - Fukushima Medical University

Condition: Condition - Patients admitted to the intensive care unit (ICU) of Fukushima Medical University Hospital who were monitored with the FloTrac system and underwent passive leg raising (PLR) testing. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to validate an artificial intelligence (AI)-based method for geometrically extracting arterial pressure waveform area ratios from photographs of physiological monitor screens acquired using a smartphone. Specifically, the study aims to determine how accurately stroke volume (SV) and cardiac output (CO) changes derived from these area ratios reflect hemodynamic changes induced by passive leg raising (PLR).

The FloTrac system, a continuous cardiac output monitoring device, will be used as the reference method. This study will evaluate the accuracy and feasibility of the proposed approach as a novel hemodynamic assessment tool that does not require specialized equipment and can be applied in a real-world intensive care unit (ICU) setting. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Patients aged 18 years or older who meet either of the following criteria will be eligible for inclusion: Patients admitted to the intensive care unit (ICU) of Fukushima Medical University Hospital between Aug 2026 and December 2028 who were monitored with the FloTrac system and underwent passive leg raising (PLR) testing. Key exclusion criteria - Data from patients or time points meeting any of the following criteria will be excluded:

1. Passive leg raising (PLR) tests performed in the presence of cardiac arrhythmias.

2. Patients receiving mechanical circulatory support (e.g., extracorporeal membrane oxygenation [ECMO]).

3. Patients in whom interpretation of the PLR test is considered difficult, or in whom the reliability of hemodynamic measurements obtained from the FloTrac system or pulmonary artery catheter (PAC) is considered inadequate. Target Size - 84

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 11 Day Date of IRB - 2026 Year 08 Month 24 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070674

Disclaimer: Curated by HT Syndication.