Clinical trial NCT06851416: Cross-Cultural Adaptation on CALCULATE in a Critical Care Unit
Official title: Cross-Cultural Adaptation and Psychometric Evaluation of the Critical Care Pressure Ulcer Assessment Tool Made Easy (CALCULATE) in a Critical Care Unit in Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Injury
Critical Care
Keywords: pressure injury
critical care
validity
reliability
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care unit patient

Brief summary: Pressure injuries are localized lesions that occur in the skin and/or underlying tissues due to pressure, or pressure in combination with shear. PIs arise as a consequence of prolonged immobility during hospitalization, leading to increased morbidity, mortality, prolonged hospital stays which may result in higher healthcare costs. Critically ill patients are vulnerable cohort of patients at a higher risk of developing PIs compared to the general population due to factors such as immobility, severity of illness, hemodynamic instability, ventilation, use of vasopressors, and the application of medical devices.

Detailed description: Despite the potential for preventing pressure injury through evidence-based, multidisciplinary approaches, critically ill patients still develop pressure injury at approximately four times the rate of other patients.While there are over forty pressure injuries risk assessment tools available, none are considered the 'gold standard,' and their assessments are based on subjective data, which may not yield valid and reliable results in clinical practice. In a study identified sixteen scales used to assess pressure injury in intensive care, with the Cubbin and Jackson Index, Braden, and Waterlow being the most common. Although the Braden scale was most frequently used, it was not considered the best tool for intensive care unit patients. In a recent review, the Critical Care Pressure Ulcer Assessment Tool made Easy was noted to outperform others in detecting pressure injuries, with the Braden and Critical Care Pressure Ulcer Assessment Tool made Easy scores showing superior performance, and Braden demonstrating the best results.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: CALCULATE Pressure Ulcer Risk Assessment Scale in Intensive Care
timeFrame: 3 days
Secondary outcomes:
measure: Braden Pressure Ulcer Risk Assessment Scale
timeFrame: 3 days
measure: Biochemical Markers
timeFrame: 1 day
Other outcomes:
Locations:
city: Fati̇h
country: Turkey
facility: Istanbul University
state: İ̇stanbul
Study officials:
affiliation: Istanbul University, Istanbul, Turkey
name: Nurten Özen, Assoc. Prof, RN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Isparta City Hospital, Isparta, Turkey
name: Fatma Nur Ceylan, MScN
role: STUDY_CHAIR
affiliation: Isparta City Hospital, Isparta, Turkey
name: Aysegül Ünlü
role: STUDY_CHAIR
affiliation: Royal College of Surgeons, Ireland
name: Natalie McEvoy, RN, PhD
role: STUDY_CHAIR
References:
citation: Theeranut A, Ninbanphot S, Limpawattana P. Comparison of four pressure ulcer risk assessment tools in critically ill patients. Nurs Crit Care. 2021 Jan;26(1):48-54. doi: 10.1111/nicc.12511. Epub 2020 May 5.
citation: Richardson A, Straughan C. Part 2: pressure ulcer assessment: implementation and revision of CALCULATE. Nurs Crit Care. 2015 Nov;20(6):315-21. doi: 10.1111/nicc.12172. Epub 2015 Mar 19.