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Simplified Acute Physiology Score 2 and Pressure Ulcer Prediction in ICU.

Using the Simplified Acute Physiology Score 2 (SAPS 2) for Predicting Pressure Ulcer Formation Among Critically Ill Patients Admitted in Medical Intensive Care Unit.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07732517
Acronym
IGS-2-MIR
Enrollment
500
Registered
2026-07-29
Start date
2027-02-01
Completion date
2028-09-01
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcers

Keywords

SAPS 2, Pressure ulcers, predictive test, Intensive Care Unit

Brief summary

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.

Detailed description

Pressure ulcers are soft tissue lesions induced when an unrelieved pressure, from a prominent bone, is applied on the skin and the underlying tissues, leading to ischemia and eventually necrosis of the area. Commonly, pressure ulcers are often located at the sacrum and heels. Yet, developing rapidly, they burden patients' illness and hospital care and costs: an increase in the length of stay of 11.2 days and additional costs of € 5,612 per patient in 2012. Although pressure ulcers are a common issue for hospitalized patients (12.5%) in France according to the SRLF, the prevalence rate is greatly higher in Intensive Care Units (30%) due to several factors inherent to the type of critically ill patients admitted: severity of the initial condition, age, weight, altered perfusion/oxygenation ratio, and length of stay. Currently, nurse staff at medical ICU Bordeaux teaching hospital are using the Braden scale as the gold standard to predict the risk for pressure ulcer formation. Despite its high sensitivity (more than 80% of critically ill adult patients are identified at high risk), this scale is well known to have a low specificity which makes its use suboptimal. This scale does not indeed process ICU-specific predictive factors for pressure ulcer risk. Some of these factors, as aforementioned, are integrated into the Simplified Acute Physiology Score 2, which assesses the severity of patients upon admission and is systematically and mandatorily collected by medical teams. Studies show that 35% of patients with a SAPS 2 ≥ 33 have pressure ulcers, compared to 17% of patients with a SAPS 2 ≤ 33, and that the risk of developing a pressure ulcer increases in conjunction with SAPS 2. Thus, the SAPS-2 could be useful for identifying patients at risk of developing pressure ulcers in ICU. Nurse staff at medical ICU Bordeaux teaching hospital therefore propose to evaluate the contribution of using the SAPS 2 (IGS-2) in addition to the Braden scale, to improve the prediction of the risk of sacral pressure ulcers, in adult patients hospitalized in medical intensive care, in order to better target patients to be treated and for a more effective and efficient use of human and material resources. We design a prospective observational cohort study, for a duration of 19 months, in which adult patients admitted in the Pellegrin medical intensive care unit will be considered for inclusion (first day) following inclusion and non-inclusion criteria. All included patients will be free of pressure ulcers upon admission. The scores studied in the project (Braden and SAPS 2/IGS-2) are measured beforehand and therefore without knowledge of the development of pressure ulcers. The prediction horizon used is 20 days, which corresponds to the maximum expected length of stay for the majority of patients in the target population.

Interventions

OTHERPressure ulcer

Skin 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

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults ≥ 18 years of age; * Patients admitted to intensive care unit; * Patients without any preexisting pressure ulcer on admission; * Capacity to give informed consent.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Determine prognostic ability of the SAPS 2 in ICU patientsFrom enrollment to 20 daysThe 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.

Countries

France

Contacts

CONTACTJulie GAUTHIER
julie.gauthier@chu-bordeaux.fr05 56 79 56 79
CONTACTRenaud PREVEL, Dr
renaud.prevel@cu-bordeaux.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026