NCT06921070

Usage and Adverse Events of Physical Restraints in an Intensive Care Unit

Usage and Adverse Events of Physical Restraints in an Intensive Care Unit - an Observational Cohort Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this retrospective observational single-center cohort study is to (1) examine the frequency of physical restraint use in a Swiss intensive care unit, (2) identify related adverse events, and (3) determine risk factors associated with their use and complications in critically ill adult patients.

Detailed description

Physical restraints are widely used in intensive care units (ICU) worldwide to protect patients by preventing them from removing medical devices, accidentally taking out breathing tubes (self-extubation), or falling. However, while they are intended to keep patients safe, restraints can also have negative effects. Their use may increase agitation, self-extubation, infections, blood clots, longer hospital stays, and even a higher risk of death. Studies have also linked physical restraints to long-term problems, such as cognitive decline and post-traumatic stress disorder. However, most studies lack strong evidence and cannot exclude the influence of other factors. This retrospective observational single-center cohort study aims to: 1. Determine the frequency with which physical restraints are used in a Swiss ICU 2. Identify the type and frequency of adverse events associated with physical restraint use 3. Identify other factors linked to physical restraints use and specific complications during intensive care of critically ill adult patients. Furthermore, the study examines the use of chemical sedation with physical restraint use and the risk of delirium. The results of this study will help improve patient care and contribute to better guidelines for physical restraint use in the ICU.

Conditions

• Physical Restraints

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-04-10
• Last updated: 2025-04-10

Locations

1 site across 1 country: Switzerland