Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07496411

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pressure Injury Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

    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).

  2. Incidence of pressure injury within 28 days

    Time frame: Daily assessment from randomization up to 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ting Yuan

CONTACT

[email protected]

13635985076

Weiqing Zhang, Ph.D

CONTACT

[email protected]

8618521525300

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.