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

NCT06921070 | Active Not Recruiting

• 1 other identifier: 2024-00057; am23Sutter
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Restraints

Keywords

Intensive Care

Outcome Measures

Primary Outcomes (20)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients younger than 18 years.
• Patients with documented refusal to use data.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Clinic for Intensive Care Medicine

Basel, Canton of Basel-City, 4031, Switzerland

Location

Study Officials

• Raoul Sutter, Prof. Dr. med.

  University Hospital Basel, Clinic for Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 10, 2025
• Study Start: March 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

CH (1)