Cross-Cultural Adaptation on CALCULATE in a Critical Care Unit

NCT06851416 | Completed

• 1 other identifier: 28.08.2024 /2024-353
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Injury; Critical Care

Keywords

pressure injury; critical care; validity; reliability

Outcome Measures

Primary Outcomes (1)

• CALCULATE Pressure Ulcer Risk Assessment Scale in Intensive Care

  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."

  3 days

Secondary Outcomes (2)

• Braden Pressure Ulcer Risk Assessment Scale

  3 days

• Biochemical Markers

  1 day

Study Arms (1)

ICU Patient

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, and who consent to participate in the study (or whose family members consent) included in the study. Patients or their family members who did not consent to participate, as well as patients who transferred to another hospital during their ICU stay, excluded from the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Fatih, İ̇stanbul, 34116, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 32368844 RESULT

• 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.

  PMID: 25787803 RESULT

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nurten Özen, Assoc. Prof, RN, PhD

  Istanbul University, Istanbul, Turkey

  PRINCIPAL INVESTIGATOR

• Fatma Nur Ceylan, MScN

  Isparta City Hospital, Isparta, Turkey

  STUDY CHAIR

• Aysegül Ünlü

  Isparta City Hospital, Isparta, Turkey

  STUDY CHAIR

• Natalie McEvoy, RN, PhD

  Royal College of Surgeons, Ireland

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisst Prof

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: September 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 31, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)