EichorEICHOR
Study identifier: NCT04957238 Synced from ClinicalTrials.gov · August 03, 2026
● Completed

Physical Restraints in Intensive Care Unit Patients

Condition: Critically Ill · Intensive Care Unit Delirium · Delirium Confusional State  ·  Sponsor: University Hospital, Clermont-Ferrand

PhaseNA
Planned participants4000
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The use of physical restraints is common practice in Intensive Care Units (ICU). This medically prescribed procedure requires full attention of medical and paramedical teams for its implementation, monitoring and ending, as a major restriction of patients\' individual freedom. French highest authority for health has defined, for geriatrics and psychiatric units, ten criteria of good practice for physical restraints' use. Routine practice reports critically ill patients' safety as main reason of use. This decision, often left to the sole discretion of nurses, varies according to their own representation of this risk, and depends on several factors: seniority in ICU, nurse to patient ratio and personal workload. In order to reduce practices subjectivity and heterogeneity, we have developed a decision-making tool for physical restraints implementation. This tool is based on objective scales used on a daily basis concerning neurological status (Richmond Agitation-Sedation Scale (RASS) and Confusion Assessment Method for the ICU (CAM-ICU)). Disorientation or delirium can lead to severe incidents by promoting accidental removing of important devices such as arterial of venous line, drains among others. However, physical restraints are recognized as a major cause of delirium and agitation. Critically ill patients require rigorous evaluation of organ dysfunctions necessitating adequate invasive equipments, with associated risks of unexpected removal or alteration. Such events c…

This description comes directly from the study's public registry record.

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Locations (19)

CH Henri MondorAurillac, France
Centre Hospitalier d'AvignonAvignon, France
Hôpital Nord Franche-ComtéBelfort, France
Centre de Lutte Contre le Cancer Jean-PerrinClermont-Ferrand, France
Centre Hospitalier Universitaire de Clermont-FerrandClermont-Ferrand, France
Centre Hospitalier Universitaire de DijonDijon, France
Centre Hospitalier du Puy en VelayLe Puy-en-Velay, France
Centre Hospitalier Universitaire - Hospices Civils de Lyon - Hôpital Edouard HerriotLyon, France
Assistance Publique-Hôpitaux de Marseille - La TimoneMarseille, France
Centre Hospitalier Universitaire de MontpellierMontpellier, France
Centre Hospitalier Moulins-YzeureMoulins, France
Centre Hospitalier Universitaire de NiceNice, France

+ 7 more locations — full list on the registry record.

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