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

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 Overview

• Status: Not yet recruiting
• Conditions: Pressure Injury
• Intervention / Treatment: Other: Ultrasound-based Quantitative Risk Score-guided Nursing Intervention; Other: Standard Pressure Injury Preventive Care

• Study Type: Interventional
• Enrollment (Estimated): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weiqing Zhang, Ph.D; Phone Number: 8618521525300; Email: weiq.zh@163.com
• Study Contact Backup: Name: Ting Yuan; Phone Number: 13635985076; Email: otblue21_white@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound-Guided Intervention Group; 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.	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.
Active Comparator: Standard Care Control Group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Daily assessment from randomization up to 28 days.

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2026
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin and Connective Tissue Diseases; Pressure Ulcer
• Other Study ID Numbers: ZWQ-PI-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No