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Not yet recruiting NCT07496411

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

No phase Interventional Pressure Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound-based Quantitative Risk Score-guided Nursing Intervention, Standard Pressure Injury Preventive Care.
Who it may be relevant to
Registry conditions: Pressure Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • 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.

Primary outcome measures

  • Area Under the Receiver Operating Characteristic Curve (AUC) of the Ultrasound-based Quantitative Risk Score [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 [Time frame: Daily assessment from randomization up to 28 days.]

Eligibility criteria

Phase 1: Tool Development and Validation (Observational)

Inclusion Criteria (Phase 1):

  • 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.

Exclusion Criteria (Phase 1):

  • 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)

Inclusion Criteria (Phase 2):

  • Meet all the general inclusion criteria from Phase 1.
  • 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):

  • Meet all the general exclusion criteria from Phase 1.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07496411 · ZWQ-PI-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗