AI-Assisted Skin Assessment for Pressure Injury Prevention in Critical Care Nurses

NCT07318571 | Recruiting DMC

• 2 other identifiers: RAC 2251201Research Ethics Committee
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

The Study Focuses on Skin Assessment and PI Staging in ICU Patients

Keywords

Artificial intelligence; critical care; intensive care; nurses; Pressure injuries

Outcome Measures

Primary Outcomes (1)

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

  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.

  Day 1 through 6 months

Secondary Outcomes (2)

• 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)

Study Arms (2)

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.

Other: ChatGPT Skin Assessment

Interventions

ChatGPT Skin Assessment OTHER

ChatGPT Skin Assessment

ChatGPT-Assisted Skin Assessmen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital and Research Center- Jeddah

Jeddah, Mecca Region, 21423, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Dr. Jennifer De Beer, PhD

CONTACT

+966559232671; debeerj@kfshrc.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nursing Research Senior Specialist

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: January 6, 2026
• Study Start: November 24, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): May 16, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)