[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631110":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":25,"responsibleParty":40,"collaborators":25,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":25,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":25,"enrollmentInfo":51,"targetDuration":25,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":25,"overallStatus":60,"whyStopped":25,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":25},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ultrasound-Guided Intervention Group","EXPERIMENTAL","Participants in this arm receive a precision nursing prevention protocol guided by the Ultrasound-based Quantitative Risk Score. The nursing strategy is dynamically adjusted based on four risk strata (low, medium, medium-high, and high risk) determined by bedside ultrasound imaging of the sacral and coccygeal regions. This protocol utilizes objective pathological markers identified via ultrasound-such as blurred tissue layers, fascial discontinuity, and hypoechoic lesions-to initiate targeted decompression and skin care measures before clinical skin breakdown occurs.",[13],"Other: Ultrasound-based Quantitative Risk Score-guided Nursing Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care Control Group","ACTIVE_COMPARATOR","Participants in this arm receive routine clinical nursing care for pressure injury prevention according to the standard operating procedures of the ICU at Ruijin Hospital. The risk assessment and corresponding preventive interventions (e.g., scheduled repositioning and standard skin care) are strictly implemented and adjusted based on the scores from the traditional Braden Scale. No ultrasound-based quantitative risk assessments are used to guide nursing interventions in this group.",[19],"Other: Standard Pressure Injury Preventive Care",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Ultrasound-based Quantitative Risk Score-guided Nursing Intervention","A precision nursing intervention based on the Ultrasound-based Quantitative Risk Score (UQRS) developed in Phase 1. Patients are stratified into four risk levels (Low, Medium, Medium-High, and High) using bedside ultrasound to detect early sub-epidermal pathological changes such as loss of fascial continuity or hypoechoic lesions. Targeted pressure-relief measures and skin care frequencies are dynamically adjusted according to these ultrasound-identified risk strata.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard Pressure Injury Preventive Care","Routine nursing care for pressure injury prevention following the standard operating procedures of the ICU at Ruijin Hospital. Risk assessment and subsequent interventions, including scheduled repositioning and standard skin care, are strictly implemented based on the results of the traditional Scale scores. No ultrasound-guided quantitative assessments are used to direct clinical decisions in this group.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Weiqing Zhang, Ph.D","CONTACT","8618521525300","weiq.zh@163.com",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Ting Yuan","13635985076","otblue21_white@163.com",{"type":41,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100631110","predictive-validity-and-clinical-utility-of-an-ultrasound-based-quantitative-risk-score-for-pressure-injury-in-critically-ill-patients-100631110",false,"NCT07496411","Predictive Validity and Clinical Utility of an Ultrasound-based Quantitative Risk Score for Pressure Injury in Critically Ill Patients","Predictive Validity and Clinical Utility of an Ultrasound-based Quantitative Risk Score for Pressure Injury in Critically Ill Patients: A Two-Phase Sequential Study","Phase 1: Tool Development and Validation (Observational)\n\nInclusion Criteria (Phase 1):\n\n1. Age \\> 18 years.\n2. Newly admitted to the Intensive Care Unit (ICU) with an expected stay of ≥ 96 hours.\n3. Intact skin in the sacrococcygeal region within 24 hours of ICU admission.\n4. Provision of signed informed consent.\n\nExclusion Criteria (Phase 1):\n\n1. Pregnant women or children.\n2. Skin conditions (e.g., scarring, burns, or tumors) in the sacrococcygeal region interfering with ultrasound.\n3. Clinical instability preventing lateral repositioning for ultrasound.\n4. History of major sacrococcygeal surgery or severe trauma.\n5. Life expectancy \\\u003C 48 hours. Phase 2: Randomized Controlled Trial (Interventional)\n\nInclusion Criteria (Phase 2):\n\n1. Meet all the general inclusion criteria from Phase 1.\n2. Meet the pre-defined risk threshold based on the Ultrasound-based Quantitative Risk Score, as determined from the analysis of Phase 1 results.\n\nExclusion Criteria (Phase 2):\n\n1. Meet all the general exclusion criteria from Phase 1.\n2. Previous participation in Phase 1 of this study (to maintain independent samples for the RCT).\n3. Current participation in other interventional trials that may impact pressure injury outcomes.","ALL","18 Years",{"count":52,"type":53},390,"ESTIMATED","INTERVENTIONAL",[56],"NA","Pressure injuries are a common and serious complication for critically ill patients in the intensive care unit (ICU). Early and accurate identification of high-risk patients is crucial for effective prevention. This two-phase sequential study aims to evaluate a new, objective assessment tool: an ultrasound-based quantitative risk score.\n\nPhase 1 is an observational study designed to test the predictive validity of this ultrasound score. Researchers will use bedside ultrasound to examine tissue integrity and determine how accurately the score can predict the development of pressure injuries. Phase 2 is a pilot randomized controlled trial. In this phase, patients will be randomly assigned to receive either standard preventive care or a targeted nursing intervention guided by the ultrasound score. The primary goal is to assess the clinical effectiveness of this score-guided intervention in reducing the occurrence of pressure injuries and improving nursing care for critically ill patients.",[59],"Pressure Injury","NOT_YET_RECRUITING","2026-03-31",{"date":63,"type":64},"2026-04-06","ACTUAL",{"date":66,"type":53},"2026-03-20",{"date":68,"type":53},"2027-07-01",{"name":5,"class":6}]