Predictive Validity and Clinical Utility of an Ultrasound-based Quantitative Risk Score for Pressure Injury in Critically Ill Patients: A Two-Phase Sequential Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Ruijin Hospital
- Enrollment
- 390
- Primary Endpoint
- Area Under the Receiver Operating Characteristic Curve (AUC) of the Ultrasound-based Quantitative Risk Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
- •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
- •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
- •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.
Arms & Interventions
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.
Intervention: Ultrasound-based Quantitative Risk Score-guided Nursing Intervention (Other)
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.
Intervention: Standard Pressure Injury Preventive Care (Other)
Outcomes
Primary Outcomes
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).
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.
Secondary Outcomes
No secondary outcomes reported