Cross-Cultural Adaptation on CALCULATE in a Critical Care Unit

Completed

• Conditions: Pressure Injury; Critical Care

• Registration Number: NCT06851416
• Lead Sponsor: Istanbul University

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.

Study Timeline

• Study Start: 2024-09-01
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CALCULATE Pressure Ulcer Risk Assessment Scale in Intensive Care	3 days	The CALCULATE was developed by Richardson and Straughan (2015) to evaluate the risk of pressure ulcer development in intensive care patients. The scale was later revised and published in its final form by Richardson and Straughan (2015), consisting of eight items. These items assess eight pressure ulcer risk factors: mechanical ventilation, impaired circulation, dialysis, prolonged surgery/cardiac arrest (surgery duration\> 4 hours in the last 24 hours or cardiac arrest during this hospital stay), fecal incontinence (diarrhea type 5, 6, or 7), low protein (albumin \<35 g/L and/or malnutrition), immobility, and instability to the extent that the patient cannot turn. Each risk factor is assigned one point, with the total score ranging from 0 to 8. Based on the scoring, patients with four or more risk factors are classified as "very high risk," while those with three or fewer risk factors are classified as "high risk."

Secondary Outcome Measures

Name	Time	Method
Biochemical Markers	1 day	Based on the literature (Hatanaka et al., 2008; Wang et al., 2022), albumin, hemoglobin, and CRP levels monitored daily throughout the patient's stay in the intensive care unit. In the intensive care unit where the study conducted, these biochemical markers are routinely measured daily for all ICU patients
Braden Pressure Ulcer Risk Assessment Scale	3 days	The Braden Pressure Ulcer Risk Assessment Scale, developed by Braden and Bergstrom (1987), was adapted into Turkish by Karadag and Avşar (2013). The scale consists of six subscales: sensory perception, moisture, activity, mobility, nutrition, and friction and shear. The subscales of sensory perception, moisture, activity, mobility, and nutrition are scored between 1 and 4, while the friction and shear subscale is scored between 1 and 3. The total score on the scale ranges from a minimum of 6 to a maximum of 23. Lower scores indicate a higher risk of developing a pressure ulcer . A total score of 15-16 indicates a low risk, 13-14 indicates a moderate risk, and 12 or below indicates a high risk. For patients aged 75 and older, a score of 15-18 is considered low risk

Trial Locations

Locations (1)

Istanbul University; 🇹🇷 Fati̇h, İ̇stanbul, Turkey

Istanbul University

🇹🇷Fati̇h, İ̇stanbul, Turkey