Predictive Validity and Clinical Utility of an Ultrasound-based Quantitative Risk Score for Pressure Injury in Critically Ill Patients: A Two-Phase Sequential Study

NCT07496411 | Not Yet Recruiting

• 1 other identifier: ZWQ-PI-2026
• Study Type: interventional
• Target: 390
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

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.

Other: Ultrasound-based Quantitative Risk Score-guided Nursing Intervention

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.

Other: Standard Pressure Injury Preventive Care

Interventions

Ultrasound-based Quantitative Risk Score-guided Nursing Intervention OTHER

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.

Ultrasound-Guided Intervention Group

Standard Pressure Injury Preventive Care OTHER

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.

Standard Care Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years.
• Newly admitted to the Intensive Care Unit (ICU) with an expected stay of ≥ 96 hours.
• Intact skin in the sacrococcygeal region within 24 hours of ICU admission.
• Provision of signed informed consent.

You may not qualify if:

• Pregnant women or children.
• Skin conditions (e.g., scarring, burns, or tumors) in the sacrococcygeal region interfering with ultrasound.
• Clinical instability preventing lateral repositioning for ultrasound.
• History of major sacrococcygeal surgery or severe trauma.
• Life expectancy \< 48 hours. Phase 2: Randomized Controlled Trial (Interventional)
• Meet the pre-defined risk threshold based on the Ultrasound-based Quantitative Risk Score, as determined from the analysis of Phase 1 results.
• Previous participation in Phase 1 of this study (to maintain independent samples for the RCT).
• Current participation in other interventional trials that may impact pressure injury outcomes.

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Weiqing Zhang, Ph.D

CONTACT

8618521525300; weiq.zh@163.com

Ting Yuan

CONTACT

13635985076; otblue21_white@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 27, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03