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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. Phase 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.

Conditions

• Pressure Injury

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2026-03-20
• Primary completion: 2027-06-20
• Completion: 2027-07-01
• First posted: 2026-03-27
• Last updated: 2026-04-06