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

NCT07732517 | Not Yet Recruiting

• 1 other identifier: CHUBX 2022/35
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcers

Keywords

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

Outcome Measures

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.

  From enrollment to 20 days

Interventions

Pressure ulcer OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Hôpital Pellegrin

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Julie GAUTHIER

CONTACT

05 56 79 56 79; julie.gauthier@chu-bordeaux.fr

Renaud PREVEL, Dr

CONTACT

renaud.prevel@cu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

FR (1)