Clinical trial NCT06921070: Usage and Adverse Events of Physical Restraints in an Intensive Care Unit
Official title: Usage and Adverse Events of Physical Restraints in an Intensive Care Unit - an Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Physical Restraints
Keywords: Intensive Care
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes all consecutive adult patients (i.e. \>= 18 years of age) being physically restrained in the intensive care unit at the University Hospital Basel between 2010 and 2023.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient demographics
timeFrame: 2010-2023
measure: Acute prehospital management data
timeFrame: 2010-2023
measure: Duration of ICU stay
timeFrame: 2010-2023
measure: Duration of hospital stay
timeFrame: 2010-2023
measure: Discharge destination
timeFrame: 2010-2023
measure: Date of physical restraint use
timeFrame: 2010-2023
measure: Reason for physical restraint use
timeFrame: 2010-2023
measure: Type of physical restraints used
timeFrame: 2010-2023
measure: Restraint Duration
timeFrame: 2010-2023
measure: Level of consciousness at onset of restraint
timeFrame: 2010-2023
measure: Clinical neurologic monitoring score
timeFrame: 2010-2023
measure: Critical illness severity score
timeFrame: 2010-2023
measure: Charlson Comorbidity Index
timeFrame: 2010-2023
measure: Laboratory parameters
timeFrame: 2010-2023
measure: Complications associated with physical restraint use
timeFrame: 2010-2023
measure: Glasgow Outcome Score
timeFrame: 2010-2023
measure: Therapeutic intervention
timeFrame: 2010-2023
measure: Vital signs
timeFrame: 2010-2023
measure: Fluid balance data
timeFrame: 2010-2023
measure: Diagnostic procedure
timeFrame: 2010-2023
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Clinic for Intensive Care Medicine
state: Basel-Stadt
Study officials:
affiliation: University Hospital Basel, Clinic for Intensive Care Medicine
name: Raoul Sutter, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: