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

April 10, 2019 updated by: French Society for Intensive Care
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1228

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France, 47923
        • Hôpital Saint-Esprit
      • Angers, France, 49000
        • CHU d'Angers
      • Antony, France, 92166
        • Hôpital Privé d'Antony
      • Ars-Laquenexy, France, 57245
        • Hopital Mercy
      • Belfort, France, 90015
        • Hôpital Nord Franche Comté
      • Bobigny, France, 93000
        • Hopital 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
        • Hôpital 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
        • Hôpital Raymond Poincaré
      • 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
        • Hôpital Laennec
      • Nice, France, 06202
        • Hôpital l'Archet
      • Nîmes, France, 30029
        • CHU Nîmes
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
      • Paris, France, 75020
        • Hôpital Tenon
      • Paris, France, 75014
        • COCHIN
      • Paris, France, 75010
        • Hopital St Louis
      • Paris, France, 75013
        • La Pitié Salpétrière
      • Paris, France, 75015
        • HEGP
      • Paris, France, 75012
        • GH Diaconnesses Croix Saint Simon
      • Paris, France, 75015
        • CHU Necker Enfants Malades
      • Paris, France, 75015
        • CHU Robert Debre
      • 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
        • Hôpital 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pressure Ulcer Presence on the study day
Time Frame: Through study completion, an average of 1 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Grade of Pressure Ulcer on the study day
Time Frame: Through study completion, an average of 1 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
Time Frame: Through study completion, an average of 1 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
French Society for Intensive Care

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Gael Piton, MD, PhD, French Intensive Care Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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