Simplified Acute Physiology Score 2 and Pressure Ulcer Prediction in ICU.
ConditionPressure Ulcers
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux
About this trial
Critically ill patients admitted in intensive care units are at high risk of developing pressure ulcer (also known as pressure injury). In Bordeaux teaching hospital, a prevalence survey identified the department of anaesthesia and Intensive Care Unit with the highest rate for pressure ulcer (up to 29% of patients). Yet, developing a PU will increase patient's pain, health expenses, and the risks for further complications such as infection, prolonged hospitalization and a higher mortality rate. Therefore, this study aims at improving pressure ulcer prediction by using the Simplified Acute Physiology Score 2 (SAPS 2) as the latter estimates the severity of a patient condition while factoring in several causative factors for pressure ulcer among ICU patients. This could then lead to a better use and allocation of human and material resources and improve patients' care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥ 18 years of age;
Patients admitted to intensive care unit;
Patients without any preexisting pressure ulcer on admission;
Capacity to give informed consent.
Disqualifiers
Length of stay less than 24 hours;
Decline to participate in the study;
Admission criteria being post-surgery monitoring and/or admission for drug intoxication
Patients admitted to ICU with a pre-existent sacral pressure ulcer (any stage).
Trial population
This is a single-centre, prospective, observational cohort study with a prognostic focus, involving patients admitted to the medical intensive care unit at Pellegrin. 500 subjects will be included in the study. Of these, 90 per cent are expected to have a Braden score of ≤12 (patients at risk of pressure ulcers), i.e. 450 patients.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Pressure ulcer
Other interventionSkin monitoring, assessment of the Braden Score, calculation of the Simplified Acute Physiology Score 2 (SAP2), dating the appearance of a sacred wound and determining its classification
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Determine prognostic ability of the SAPS 2 in ICU patients
The primary outcome is to determine the prognostic ability (sensitivity, specificity, positive predictive value, and negative predictive value) of the SAPS 2 in ICU patients classified as at risk of pressure ulcer according to the Braden Scale: * Test to be evaluated: The SAPS 2 obtained on admission. * Reference test: The occurrence or absence of stage I pressure ulcer using the EPUAP/NPIAP classification through direct observation between days 1 and 20. For participants discharged from the ICU within 20 days, the presence or absence of a sacral pressure ulcer at discharge will be used as the final status for the analysis.
Time frame
From enrollment to 20 daysSponsors and contacts
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Source ClinicalTrials.gov
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