Pressure InjuryCALCULATENCT06851416
Cross-Cultural Adaptation on CALCULATE in a Critical Care Unit
An observational study of Pressure Injury and Critical Care, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury, Critical Care
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 31 Dec 2024
- How long will I take part?
- 3 Days
- 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 years and older
- All sexes
- Healthy volunteers accepted
- 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: Cross-Cultural Adaptation and Psychometric Evaluation of the Critical Care Pressure Ulcer Assessment Tool Made Easy (CALCULATE) in a Critical Care Unit in Turkey
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.
Read the 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.
- Conditions
- Pressure Injury, Critical Care
- Keywords
- pressure injury, critical care, validity, reliability
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 3 days
Secondary outcomes (2)
Braden Pressure Ulcer Risk Assessment Scale
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
Measured: 3 days
Biochemical Markers
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Sep 2024
- Primary completion1 Nov 2024
- Study completion31 Dec 2024
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 InjuryStudies 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
- 86 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu POLAT DÜNYA, Istanbul University
- Investigators
- Nurten Özen, Assoc. Prof, RN, PhD, Principal investigator, Istanbul University, Istanbul, TurkeyFatma Nur Ceylan, MScN, Study chair, Isparta City Hospital, Isparta, TurkeyAysegül Ünlü, Study chair, Isparta City Hospital, Isparta, TurkeyNatalie McEvoy, RN, PhD, Study chair, Royal College of Surgeons, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851416
- Sponsor's protocol ID
- 28.08.2024 /2024-353
- Acronym
- CALCULATE
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32368844Richardson 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.
PubMed 25787803
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06851416
- Acronym / sponsor ID
- CALCULATE / 28.08.2024 /2024-353
- Conditions
- Pressure Injury, Critical Care
- Keywords
- pressure injury, critical care, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Feb 2025 (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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care unit patient
Key inclusion criteria (4 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
CALCULATE Pressure Ulcer Risk Assessment Scale in Intensive Care
Time frame: 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."
2 secondary outcomes
Braden Pressure Ulcer Risk Assessment Scale
Time frame: 3 days
Biochemical Markers
Time frame: 1 day
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 28 Feb 2025.
- Results publication: PubMed 32368844Theeranut 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.
- Results publication: PubMed 25787803Richardson 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.
- 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 Özen, Assoc. Prof, RN, PhD principal investigator
Istanbul University, Istanbul, Turkey
Fatma Nur Ceylan, MScN study chair
Isparta City Hospital, Isparta, Turkey
Aysegül Ünlü study chair
Isparta City Hospital, Isparta, Turkey
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 Injury and Critical Care, 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 4 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 28 Feb 2025. 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?
CALCULATE 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 NCT06851416, 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 28 Feb 2025.