跳至主要内容
临床试验/NCT07318571
NCT07318571招募中不适用

A Randomized Controlled Trial on the Application of Artificial Intelligence (AI) in Skin Assessment for Pressure Injury Prevention and Staging by Critical Care Nurses

King Faisal Specialist Hospital & Research Center1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年11月24日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Agreement Between Nurse and Expert Skin Assessment and Pressure Injury Staging Using NPIAP Criteria

研究概览

简要总结

The goal of this clinical trial is to learn whether an artificial intelligence (AI)-assisted skin assessment tool can improve the accuracy of pressure-injury staging in critical-care nurses. The study also aims to understand whether the AI tool increases nurses' knowledge and confidence in performing skin assessments. The main questions it aims to answer are:

Does AI-assisted assessment improve the accuracy of pressure-injury staging compared with standard visual assessment?

Does the use of AI improve nurses' knowledge and confidence related to skin assessment and pressure-injury staging?

Researchers will compare nurses who use an AI-assisted mobile application with nurses who perform standard manual assessments to see whether the AI tool improves staging accuracy and supports early identification of pressure injuries.

Participants will:

Complete brief questionnaires about their knowledge and confidence before and after training

Perform skin assessments on their assigned ICU patients using either standard methods or the AI tool.

Have their assessments compared with those of a blinded wound-care specialist, who will determine the most accurate staging

详细描述

Pressure injuries remain a significant and largely preventable complication among critically ill patients, with ICU populations at particularly high risk due to immobility, hemodynamic instability, and complex medical needs. At KFSHRC-Jeddah, more than half of all hospital-acquired pressure injuries reported in 2024 occurred in critical-care settings, underscoring ongoing challenges in early detection and consistent staging. Although the organization follows evidence-based practices and uses tools such as the Braden Scale and NPIAP staging guidelines, variability in nurses' knowledge, skill, and confidence continues to influence prevention quality and accuracy of assessment.

Traditional skin assessment relies primarily on visual inspection and clinical judgement, which can lead to inconsistent interpretation of early tissue changes, particularly in darker skin tones, deep tissue injuries, and moisture-associated skin damage. These limitations highlight the need for innovative approaches that support more consistent and objective staging.

Artificial intelligence (AI)-assisted image recognition has emerged as a potentially valuable adjunct to standard nursing assessment. By analyzing skin characteristics such as color, texture, and contour, AI tools may assist nurses in identifying early-stage changes and provide decision support aligned with NPIAP criteria. Integrating AI into routine practice has the potential to enhance early detection, improve staging accuracy, and reduce practice variation.

This randomized controlled trial evaluates the use of an AI-assisted mobile application compared with standard manual skin assessment performed by critical-care nurses. The intervention uses an image-recognition tool that analyzes standardized photographs of high-risk skin areas and provides staging recommendations based on NPIAP definitions. Nurses in the control group will continue performing traditional visual and palpation-based assessments according to existing hospital protocols.

All participating nurses will receive pre-intervention education on pressure injury prevention, comprehensive skin assessment, and NPIAP staging to establish a consistent baseline. The intervention group will undergo additional training on standardized image capture to ensure appropriate lighting, distance, and positioning. A blinded wound-care specialist will independently review all assessments and images; this external review serves as the reference standard for evaluating accuracy and inter-rater reliability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

A senior wound-care specialist, blinded to allocation, will independently review anonymized images and bedside assessments. Each assessment will be coded, and the expert's determinations will serve as the gold standard for inter-rater reliability testing

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Nurses working within the organisation for at least 6 months
  • Nurses involved in direct patient care for over 50% of their work time.
  • Skin assessments and staging for patients at risk for developing pressure injuries (Using the Braden Scoring system).
  • Adult Patients (18 years and older)
  • Patients who are currently admitted to the ICU and are receiving critical care treatment.
  • No current severe skin conditions patients without active severe dermatological conditions (e.g., large open wounds, severe rashes) that would interfere with the AI-based skin assessment process.

排除标准

  • Nurses working within the organization for less than 6 months
  • Nurses involved in direct patient care for less than 50% of their work time
  • End-of-Life Care or Terminal Illness- patients receiving end-of-life care or those with a terminal diagnosis, where the prevention of pressure injuries may not be a priority and where participation in the study may not align with their care goals.
  • Severe or active dermatological conditions- patients with active skin conditions such as severe rashes, burns, or other dermatological issues that could interfere with accurate skin assessments by AI or confound the study results.
  • Recent Skin Grafts or Advanced Wound Care- patients who have recently undergone skin grafts or those receiving complex wound care treatments that are outside the scope of typical pressure injury prevention practices.
  • Inability to Maintain Required Positioning for Skin Assessment- patients who are physically unable to remain in the necessary position for the skin assessments, either due to severe mobility restrictions or critical medical conditions.

研究组 & 干预措施

Standard Assessment

No Intervention

Standard assessment

ChatGPT-Assisted Skin Assessmen

Other

Nurses will use ChatGPT-based AI support to assist in skin assessment and staging.

干预措施: ChatGPT Skin Assessment (Other)

结局指标

主要结局

Agreement Between Nurse and Expert Skin Assessment and Pressure Injury Staging Using NPIAP Criteria

时间窗: Day 1 through 6 months

The primary outcome explicitly measures agreement between nurse-assigned and expert-assigned pressure injury stages using the National Pressure Injury Advisory Panel (NPIAP) staging criteria, rather than stating a study objective. Agreement will be quantified using Cohen's Kappa statistic, and accuracy will be summarized as the percentage of nurse-assigned stages that exactly match expert-assigned stages. Agreement analyses will be conducted separately for manual nurse assessments and AI-assisted nurse assessments, allowing clear and reportable comparison between study groups. Agreement outcomes will be summarized across individual assessment domains, including erythema, discoloration, edema, temperature, and overall pressure injury staging, using quantitative agreement metrics. The primary outcome will be assessed from Day 1 through 6 months.

次要结局

  • Knowledge- Change From Baseline in Nurse Knowledge Score on the Pressure Ulcer Prevention Knowledge Assessment Instrument (PUPKAI)(Day 1 (Baseline) and Day 1 (Immediately Post-intervention))
  • Change From Baseline in Nurse Confidence Score on the Skin Assessment Confidence Scale (SACS)(Day 1 (Baseline) and Day 1 (Immediately Post-intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer De Beer

Nursing Research Senior Specialist

King Faisal Specialist Hospital & Research Center

研究点 (1)

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