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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Phase 1: Tool Development and Validation (Observational)
Inclusion Criteria (Phase 1):
Exclusion Criteria (Phase 1):
Inclusion Criteria (Phase 2):
Exclusion Criteria (Phase 2):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiqing Zhang, Ph.D | Contact | 8618521525300 | weiq.zh@163.com | |
| Ting Yuan | Contact | 13635985076 | otblue21_white@163.com |
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| 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. |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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