Tokyo, Aug. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062485) titled 'Establishment of an Early Detection Method and Validation of Predictive Performance for Intensive Care Unit-Acquired Weakness (ICUAW)' on Aug. 10.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Sapporo Medical University School of Medicine

Condition: Condition - Intensive Care Unit-Acquired Weakness (ICUAW) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to measure movement-related potential (MRP) amplitude and excitation-contraction coupling time (ECCT) during the early phase of intensive care unit (ICU) admission (within 7 days) in critically ill patients and to clarify the association between these electrophysiological parameters and the subsequent development of intensive care unit-acquired weakness (ICUAW). Furthermore, this study will evaluate whether MRP amplitude and ECCT obtained during the early ICU stay can discriminate patients who subsequently develop ICUAW, thereby assessing their utility as bedside tools for the early detection of ICUAW. The rationale for this study is that, although ICUAW has a substantial impact on the prognosis of critically ill patients, objective diagnosis during the early phase of ICU admission remains challenging using currently available clinical assessment methods alone. By employing a non-invasive and relatively simple electrophysiological approach, this study may facilitate the early identification of the pathophysiological changes associated with ICUAW and support timely clinical decision-making regarding early intervention. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Nerve conduction studies and MRP/ECCT measurements using a piezoelectric sensor during the early phase of ICU stay (within 7 days of ICU admission)

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who meet all of the following criteria will be eligible for enrollment:

Patients admitted to the ICU at Sapporo Medical University Hospital Patients aged 18 years or older Patients in whom the study measurements can be performed early after ICU admission (within 7 days) Patients (or their legally acceptable representative) who have provided written informed consent for participation in this study Key exclusion criteria - Patients who meet any of the following criteria will not be eligible for enrollment:

Patients judged to have significant confounding of ICUAW assessment due to pre-existing neuromuscular disease, spinal cord disease, or severe central nervous system impairment Patients in whom appropriate testing is difficult due to skin disorders, trauma, infection, or other conditions at the measurement muscle or stimulation site Patients in whom the specified measurements are difficult to perform due to limb amputation, marked contracture, or other reasons Patients judged unsuitable for study participation by the principal investigator, sub-investigator, or attending physician Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 10 Day Anticipated trial start date - 2026 Year 08 Month 15 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071517

Disclaimer: Curated by HT Syndication.