Cross-Cultural Adaptation on CALCULATE in a Critical Care Unit

NCT ID: NCT06851416

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Pressure Injury Critical Care

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Cansu POLAT DÜNYA

Asisst Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nurten Özen, Assoc. Prof, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University, Istanbul, Turkey

Fatma Nur Ceylan, MScN

Role: STUDY_CHAIR

Isparta City Hospital, Isparta, Turkey

Aysegül Ünlü

Role: STUDY_CHAIR

Isparta City Hospital, Isparta, Turkey

Natalie McEvoy, RN, PhD

Role: STUDY_CHAIR

Royal College of Surgeons, Ireland

Locations

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Istanbul University

Fatih, İ̇stanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 32368844 (View on PubMed)

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.

Reference Type RESULT
PMID: 25787803 (View on PubMed)

Other Identifiers

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28.08.2024 /2024-353

Identifier Type: -

Identifier Source: org_study_id

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