Pressure Incidence PreventionTTV: EVARUCINCT07575581
Psychometric Evaluation of the EVARUCI Scale in Turkish Intensive Care Units
An observational study of Pressure Incidence Prevention, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pressure Incidence Prevention
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 1 Feb 2026
- How long will I take part?
- 100 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care unit patient
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: From Translation to Validation: Psychometric Evaluation of the EVARUCI Scale in Turkish Intensive Care Units
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.
Read the detailed description
A scoping review examining pressure injury risk assessment tools in critically ill patients across eight databases reported that the Risk Assessment Scale for Pressure Ulcers in Intensive Care demonstrated superior performance indicators, while the CALCULATE scale was highlighted as a recent, appropriate, simple, and user-friendly instrument, although both still require further refinement. In a study by Guerrero-Toapanta et al., EVARUCI was found to be a suitable tool for assessing PI risk in ICU patients, with the optimal assessment time identified as 48 hours after admission. 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.
- Conditions
- Pressure Incidence Prevention
- Keywords
- pressure injury, nursing, prevention
- Medical subject headings
- Pressure Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Oct 2025
- Primary completion1 Jan 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pressure Incidence PreventionStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 100 Months
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurten Ozen, Istanbul University
- Investigators
- Nurten Ozen, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575581
- Sponsor's protocol ID
- 2024/400
- Acronym
- TTV: EVARUCI
- Status last verified
- May 2026
- First submitted
- 2 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24280770Picoito 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.
PubMed 37820213
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Translation to Validation: Psychometric Evaluation of the EVARUCI Scale in Turkish Intensive Care Units
- ClinicalTrials.gov ID
- NCT07575581
- Acronym / sponsor ID
- TTV: EVARUCI / 2024/400
- Conditions
- Pressure Incidence Prevention
- Keywords
- pressure injury, nursing, prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A scoping review examining pressure injury risk assessment tools in critically ill patients across eight databases reported that the Risk Assessment Scale for Pressure Ulcers in Intensive Care demonstrated superior performance indicators, while the CALCULATE scale was highlighted as a recent, appropriate, simple, and user-friendly instrument, although both still require further refinement. In a study by Guerrero-Toapanta et al., EVARUCI was found to be a suitable tool for assessing PI risk in ICU patients, with the optimal assessment time identified as 48 hours after admission. 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 100 Months
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care unit patient
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EVARUCI Pressure Ulcer Risk Assessment Scale in Intensive Care
Time frame: 3 days
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 24280770Garcia-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.
- Background: PubMed 37820213Picoito 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurten Ozen principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Incidence Prevention, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EVARUCI Pressure Ulcer Risk Assessment Scale in Intensive Care (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07575581, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.