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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Physical Restraints

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.

• Study Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Basel-City
    • Basel, Canton of Basel-City, Switzerland, 4031
      • University Hospital Basel, Clinic for Intensive Care Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient demographics	Demographic information (e.g. age, sex) is collected to assess potential associations with physical restraint use.	2010-2023
Acute prehospital management data	Data from acute prehospital management, as documented in emergency medical services (EMS) treatment protocols, is collected	2010-2023
Duration of ICU stay	The length of ICU stay is recorded.	2010-2023
Duration of hospital stay	The length of the total hospital stay is recorded.	2010-2023
Discharge destination	The destination at discharge is recorded.	2010-2023
Date of physical restraint use	The specific date of physical restraint use to each patient is documented.	2010-2023
Reason for physical restraint use	The documented reason for applying physical restraints, as recorded in nursing and physician progress notes, is analyzed.	2010-2023
Type of physical restraints used	The specific type of physical restraints used to patients during ICU stay is recorded.	2010-2023
Restraint Duration	To characterize the restraint period, the duration of the physical restraint period is collected from the patient record in the hospital file.	2010-2023
Level of consciousness at onset of restraint	To characterize the restraint period, the patient's level of consciousness at the onset of physical restraint is collected from the patient record in the hospital file.	2010-2023
Clinical neurologic monitoring score	A score from validated neurological assessment tool (e.g., RASS, SAS, GCS, ICDSC, STESS) is recorded during the ICU stay. The specific tool used, as well as the scale of the score and meaning behind the score, depends on the neurological assessment documented in the patient register.	2010-2023
Critical illness severity score	Disease severity is assessed using a standardized scoring system recorded in the patient register, such as APACHE II, SAPS II, and SOFA. The specific scoring system used depends on the clinical documentation available. The scale of the score and meaning behind the score depends on the severity assessment that has been applied.	2010-2023
Charlson Comorbidity Index	The Charlson Comorbidity Index (CCI) is calculated based on pre-existing comorbidities and additional diagnoses. The CCI predicts the ten-year mortality for a patient who may have a range of comorbid conditions. It assigns weighted scores (from 0 to maximal 6) to 17 comorbid conditions (e.g., heart disease, diabetes, cancer), resulting in a total score ranging from 0 to 33, if the patient had the most severe form of each of the 17 conditions.	2010-2023
Laboratory parameters	Routine laboratory value for e.g. CRP, albumin, LDH, CK, procalcitonin, white blood cell levels, creatinine, liver enzymes, blood gas analyses, and metabolic data, is collected. The specific parameters recorded may vary depending on the laboratory assessments documented in the patient register. All values will be reported using their respective units of measurement.	2010-2023
Complications associated with physical restraint use	The complication occurring during or after physical restraint use, including infections, shock, hemorrhage, ischemia, hypoxia, arrhythmia, cardiopulmonary arrest, and organ failure, is recorded.	2010-2023
Glasgow Outcome Score	The Glasgow Outcome Score (GOS) is calculated based on the assessment of key clinical outcomes such as in-hospital mortality, survival, survival with neurofunctional alteration, return to premorbid neurological function, and hospital readmission to determine the patient outcome. The GOS ranges from 1 (death) to 5 (good recovery).	2010-2023
Therapeutic intervention	The therapeutic intervention is document based on the data available in the patient register. This includes information on treatment duration, dosage and number of treatment medication, number of neuroleptic, sedative and analgesic drugs, invasive procedures, such as intubation, mechanical, ventilation, vasopressors, installation of central lines, nutrition, etc. The specific interventions recorded depend on the clinical documentation available. All reported values will follow their respective units of measurement.	2010-2023
Vital signs	Vital signs are analyzed based on the data available in the patient register. These may include blood pressure, heart rate, respiratory rate, oxygen saturation, body temperature, and level of consciousness. The specific parameters recorded depend on the clinical documentation available. All values will be reported using their respective units of measurement. The collected parameters are aggregated to provide an overall assessment of the patient's clinical condition.	2010-2023
Fluid balance data	Fluid balance data, including the administration of fluids such as blood products, crystalloids, and enteral/parenteral nutrition, are documented	2010-2023
Diagnostic procedure	The diagnostic procedure (invasive or non-invasive) during intensive care, such as radiologic imaging, lumbar puncture, etc. and restraint usage during such diagnostic procedures is documented.	2010-2023

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Raoul Sutter, Prof. Dr. med., University Hospital Basel, Clinic for Intensive Care Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Intensive Care
• Other Study ID Numbers: 2024-00057; am23Sutter

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No