Physical Restraints in Intensive Care Unit Patients

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Jun 30, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the use of physical restraints in patients who are critically ill and being treated in the Intensive Care Unit (ICU). Physical restraints are sometimes used to keep patients safe, especially if they might accidentally pull out important medical devices like IV lines. However, these restraints can also lead to feelings of confusion and agitation. To address this, researchers have developed a decision-making tool that helps healthcare providers decide when it is appropriate to use restraints, based on objective assessments of a patient’s mental state.

To be eligible for this study, participants must be over 18 years old and have been in the ICU for at least 48 hours. They need to agree to participate, or their family member or trusted person can provide consent on their behalf. Throughout the study, participants can expect careful monitoring and support as the team evaluates the effectiveness of the new decision-making tool. This trial aims to improve patient care by reducing unnecessary use of restraints and enhancing safety in the ICU.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient, male or female, over 18 years of age, hospitalized in ICU for at least 48 hours.
• • Consent to participate in the patient's study or authorization to carry out the research collected from the designated trustworthy person (failing this, a family member, or failing this, a close and stable relation with the person concerned) according to the modalities described in Title II of the book of the First Public Health Code. If no relative is present, the patient may be included on the advice of the investigator (article L. 1111-6). A consent form for continuation of the study and use of the data will then be signed by the patient if and when the patient is again conscious and lucid, or if the patient is unable to express consent, authorization to continue the research will be obtained from the designated trusted person.
• • Patient covered by a social security system.
• Exclusion Criteria:
• • Predictable and uninterrupted maintenance of deep sedation throughout the duration of the stay, due to the seriousness of the lesions, from the moment the patient is admitted to the intensive care unit.
• • Lack of predictable remission of a severe coma present on admission to intensive care.
• • Refusal to participate by the patient, or by the trusted person contacted by default.
• • Patient with DNR (do not resuscitate) orders.
• • Patient under legal protection.
• • Patient already included in the protocol during another stay in resuscitation