Prevalence of Pressure Ulcers Among Critically Ill Patients and Factors Associated With Their Occurrence in the ICU (PRESSURE)

The prevalence of and risk factors for pressure ulcers (PUs) in critically ill patients have been poorly studied. The main objective of this study was to describe the prevalence of PUs in critically ill patients. Secondary objectives were to describe PUs, means of prevention of PUs, and factors associated with occurrence of PUs in the ICU.

Study Overview

• Status: Completed
• Conditions: Critical Care; Pressure Ulcer; Intensive Care Unit Syndrome
• Intervention / Treatment: Other: Pressure Ulcer Evaluation

Detailed Description

Pressure ulcers (PUs) among hospitalized patients are associated with a poor prognosis and with a high cost of care. Hospitalization in the ICU is a context where there is a high risk of occurrence of PUs, prevention of which is a priority for ICU teams caring for critically ill patients. However, the literature is inconclusive regarding the prevalence of PUs among critically ill patients and the associated risk factors. The main objective of this study was to describe the prevalence of PUs among critically ill patients hospitalized in the ICU. Secondary objectives were to describe means of prevention of PUs in the ICU and the characteristics of PUs, and to identify factors either related to the ICU or patient characteristics associated with occurrence of PUs in the ICU.

• Study Type: Observational
• Enrollment (Actual): 1228

Contacts and Locations

Study Locations

• France
  • Agen, France, 47923
    • Hôpital Saint-Esprit
  • Angers, France, 49000
    • CHU d'Angers
  • Antony, France, 92166
    • Hopital Prive d'Antony
  • Ars-Laquenexy, France, 57245
    • Hopital Mercy
  • Belfort, France, 90015
    • Hopital Nord Franche Comte
  • Bobigny, France, 93000
    • Hôpital Avicenne
  • Bordeaux, France, 33000
    • CHU Pellegrin
  • Bordeaux, France, 33075
    • Hopital St-Andre
  • Boulogne Billancourt, France, 92100
    • Hôpital Ambroise Paré
  • Brest, France, 29240
    • HIA Clermont Tonnerre
  • Clamart, France, 92140
    • Hôpital Antoine Béclère
  • Clamart, France, 92190
    • HIA Percy
  • Colombes, France, 92700
    • Hopital Louis Mourier
  • Corbeil-Essonnes, France, 91100
    • Groupe Hospitalier Sud Ile de France
  • Cornebarrieu, France, 31700
    • Clinique des Cèdres
  • Creteil, France, 94010
    • CHU Henri Mondor
  • Dijon, France, 21709
    • CHU Dijon Bourgogne
  • Eaubonne, France, 95600
    • Hôpital Simone Veil
  • Garches, France, 92380
    • Hopital Raymond Poincare
  • Grenoble, France, 38700
    • Chu Grenoble Alpes
  • Jossigny, France, 77600
    • Grand Hôpital de l'Est Francilien
  • La Réunion, France, 97400
    • CHU Réunion Saint Pierre
  • Le Kremlin-Bicêtre, France, 94270
    • CHU Kremlin-Bicêtre
  • Lille, France, 59037
    • Hôpital Roger Salengro
  • Lyon, France, 69003
    • HIA Desgenettes Lyon
  • Lyon, France, 69437
    • Groupe Hospitalier Edouard Herriot
  • Mantes-la-Jolie, France, 78200
    • Hopital Francois Quesnay
  • Marseille, France, 13385
    • Hôpital de la Timone
  • Marseille, France, 13003
    • Hôpital Européen Marseille
  • Marseille, France, 13015
    • CHU Marseille Hopital Nord
  • Metz, France, 57038
    • Hopital Notre-Dame de Bon Secours
  • Montfermeil, France, 93370
    • GHIRM
  • Montpellier, France, 34090
    • CHU Lapeyronie
  • Nancy, France, 54035
    • CHU Nancy
  • Nantes, France, 44000
    • CHU Nantes
  • Nantes, France, 44035
    • Hopital Laennec
  • Nice, France, 06202
    • Hôpital l'Archet
  • Nîmes, France, 30029
    • CHU Nîmes
  • Paris, France, 75014
    • Institut Mutualiste Montsouris
  • Paris, France, 75020
    • Hopital Tenon
  • Paris, France, 75014
    • COCHIN
  • Paris, France, 75010
    • Hôpital St Louis
  • Paris, France, 75013
    • La Pitié Salpêtrière
  • Paris, France, 75015
    • HEGP
  • Paris, France, 75012
    • GH Diaconnesses Croix Saint Simon
  • Paris, France, 75015
    • CHU Necker Enfants Malades
  • Paris, France, 75015
    • CHU Robert Debré
  • Poitiers, France, 86021
    • CHU Poitiers
  • Quincy-sous-Sénart, France, 91480
    • Hôpital privé Claude Galien
  • Saint-Jean, France, 31240
    • Clinique de l'Union
  • St-Denis, France, 93200
    • Hopital DELAFONTAINE
  • St-Mande, France, 94160
    • HIA Béjin
  • Strasbourg, France, 67200
    • CHU Strasbourg
  • Sète, France, 34200
    • Hôpital Saint Clair
  • Toulouse, France, 31400
    • CHU TOULOUSE Rangueil
  • Tremblay-en-France, France, 93290
    • Hopital Privé du Vert Galan
  • Valenciennes, France, 59322
    • Hopital Jean Bernard
  • Villejuif, France, 94805
    • Institut Gustave Roussy
  • Villenave-d'Ornon, France, 33140
    • HIA Robert Pique
  • Yerres, France, 91330
    • Hopital Privé du Val d'Yerres

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient in Critical Care during study day.

Description

The inclusion criteria were :

• hospitalization in the ICU
• age ≥ 18 years.

The exclusion criterion was:

- refusal to participate in the study by the patient or by the patient's family when the patient was unable to consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure Ulcer Presence on the study day	Presence (1) or absence (0) of pressure ulcer (however grade of pressure ulcer) during the study period which is a 1 Day Study Prevalence	Through study completion, an average of 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade of Pressure Ulcer on the study day	Grade (from 1 to 4) of pressure ulcer during the study period which is a 1 Day Study Prevalence	Through study completion, an average of 1 day
Area of Pressure Ulcer on the study day	Area on the patient's body of pressure ulcer during the study period which is a 1 Day Study Prevalence	Through study completion, an average of 1 day

Collaborators and Investigators

• Sponsor: French Society for Intensive Care
• Investigators: Study Chair: Gael Piton, MD, PhD, French Intensive Care Society

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (ACTUAL): April 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 11, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: PRESSURE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No