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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Ultrasound-based Quantitative Risk Score-guided Nursing Intervention

    Other 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.

  • Standard Pressure Injury Preventive Care

    Other intervention

    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.

Treatment groups

390 Participants
are divided into 2 treatment groups
Group A: Ultrasound-Guided Intervention GroupExperimental treatment 1 intervention
Group B: Standard Care Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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