NCT07575581

Brief Summary

International guidelines recommend the use of Pressure Injury risk assessment tools. According to these guidelines, a systematic approach to assessing risk for PI development is essential. Although several tools have been developed, no single clinical pathway is considered superior. Instead, a comprehensive evaluation of risk factors, combined with visual skin assessment, is recommended. The aim of this study was to evaluate the applicability of the EVARUCI Scale in a Turkish intensive care unit setting by performing cross-cultural adaptation and linguistic validation, and to examine its validity and reliability through psychometric testing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 2, 2026

Last Update Submit

May 2, 2026

Conditions

Keywords

pressure injurynursingprevention

Outcome Measures

Primary Outcomes (1)

  • EVARUCI Pressure Ulcer Risk Assessment Scale in Intensive Care

    The EVARUCI was developed specifically for intensive care unit patients based on studies of common risk factors for pressure injuries in Spain. González et al. (2004) found that the EVARUCI scale had a suitable reliability when tested. Subsequently, Roca et al. (2015) concluded that the interobserver concordance for the EVARUCI scale was very high. The EVARUCI scale assesses level of consciousness, hemodynamic and respiratory status, and the mobility status of the patient. Each of these parameters is scored from 0 to 4. A fifth category called "other" assesses risk factors such as temperature, skin status, blood pressure, prone position, and length of stay in the ICU. The total score ranges from 4 (minimum risk) to 23 (maximum risk).

    3 days

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intensive care unit patient

You may qualify if:

  • Patients who are 18 years or older
  • without a pressure injury at the time of ICU admission
  • expected to stay in the ICU for at least 72 hours who consent to participate in the study (or whose family members consent) included in the study.

You may not qualify if:

  • Patients or their family members who did not consent to participate
  • Patients who transferred to another hospital during their ICU stay, excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Garcia-Fernandez FP, Pancorbo-Hidalgo PL, Agreda JJ. Predictive capacity of risk assessment scales and clinical judgment for pressure ulcers: a meta-analysis. J Wound Ostomy Continence Nurs. 2014 Jan-Feb;41(1):24-34. doi: 10.1097/01.WON.0000438014.90734.a2.

    PMID: 24280770BACKGROUND
  • Picoito RJBR, Lapuente SMMPDC, Ramos ACP, Rabiais ICM, Deodato SJ, Nunes EMGT. Risk assessment instruments for pressure ulcer in adults in critical situation: a scoping review. Rev Lat Am Enfermagem. 2023 Oct 6;31:e3983. doi: 10.1590/1518-8345.6659.3983. eCollection 2023.

    PMID: 37820213BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nurten Ozen

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
100 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 2, 2026

First Posted

May 8, 2026

Study Start

October 1, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations