Predictive Validity and Clinical Utility of an Ultrasound-based Quantitative Risk Score for Pressure Injury in Critically Ill Patients: A Two-Phase Sequential Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 390
- 主要终点
- Area Under the Receiver Operating Characteristic Curve (AUC) of the Ultrasound-based Quantitative Risk Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 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.
干预措施: Standard Pressure Injury Preventive Care (Other)
结局指标
主要结局
Area Under the Receiver Operating Characteristic Curve (AUC) of the Ultrasound-based Quantitative Risk Score
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点