Predictive Validity and Clinical Utility of an Ultrasound-based Quantitative Risk Score for Pressure Injury in Critically Ill Patients

N/ANot Yet RecruitingNCT07496411

Ruijin Hospital390 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

390

Conditions

Pressure Injury

Interventions

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.

Standard Pressure Injury Preventive CareOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Phase 1: Tool Development and Validation (Observational) Inclusion Criteria (Phase 1): 1. Age \> 18 years. 2. Newly admitted to the Intensive Care Unit (ICU) with an expected stay of ≥ 96 hours. 3. Intact skin in the sacrococcygeal region within 24 hours of ICU admission. 4. Provision of signed informed consent. Exclusion Criteria (Phase 1): 1. Pregnant women or children. 2. Skin conditions (e.g., scarring, burns, or tumors) in the sacrococcygeal region interfering with ultrasound. 3. Clinical instability preventing lateral repositioning for ultrasound. 4. History of major sacrococcygeal surgery or severe trauma. 5. Life expectancy \< 48 hours. Phase 2: Randomized Controlled Trial (Interventional) Inclusion Criteria (Phase 2): 1. Meet all the general inclusion criteria from Phase 1. 2. Meet the pre-defined risk threshold based on the Ultrasound-based Quantitative Risk Score, as determined from the analysis of Phase 1 results. Exclusion Criteria (Phase 2): 1. Meet all the general exclusion criteria from Phase 1. 2. Previous participation in Phase 1 of this study (to maintain independent samples for the RCT). 3. Current participation in other interventional trials that may impact pressure injury outcomes.

Outcomes

Primary Outcomes

Area Under the Receiver Operating Characteristic Curve (AUC) of the Ultrasound-based Quantitative Risk Score

To evaluate the predictive validity of the Ultrasound-based Quantitative Risk Score for new-onset pressure injuries compared to traditional clinical scales (Braden, Norton, Waterlow, and Cubbin \& Jackson).

Time frame: Assessed at baseline (within 24h), and on days 4, 7, 14, 21, and 28 post-ICU admission.

Incidence of pressure injury within 28 days

The proportion of participants who develop at least one new sacral pressure injury (Stage 1 or higher according to NPUAP/EPUAP criteria) during the study period.

Time frame: Daily assessment from randomization up to 28 days.