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

NCT ID: NCT06921070

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Physical Restraints

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adult patients (i.e., patients ≥18 years of age)
* Being physically restrained in the intensive care unit at the University Hospital Basel between 2010 and 2023

Exclusion Criteria

* Patients younger than 18 years.
* Patients with documented refusal to use data.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raoul Sutter, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Clinic for Intensive Care Medicine

Locations

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University Hospital Basel, Clinic for Intensive Care Medicine

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2024-00057; am23Sutter

Identifier Type: -

Identifier Source: org_study_id

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