Physical RestraintsNCT06921070
Usage and Adverse Events of Physical Restraints in an Intensive Care Unit
An observational study of Physical Restraints, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Restraints
- How many people
- 2,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients younger than 18 years.
- Patients with documented refusal to use data.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Clinic for Intensive Care Medicine
Basel, Canton of Basel-City, 4031
About this study
Official title: 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.
Read the 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:
- Determine the frequency with which physical restraints are used in a Swiss ICU
- Identify the type and frequency of adverse events associated with physical restraint use
- 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
- Keywords
- Intensive Care
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient demographics
Demographic information (e.g. age, sex) is collected to assess potential associations with physical restraint use.
Measured: 2010-2023
Acute prehospital management data
Data from acute prehospital management, as documented in emergency medical services (EMS) treatment protocols, is collected
Measured: 2010-2023
Duration of ICU stay
The length of ICU stay is recorded.
Measured: 2010-2023
Duration of hospital stay
The length of the total hospital stay is recorded.
Measured: 2010-2023
Discharge destination
The destination at discharge is recorded.
Measured: 2010-2023
Date of physical restraint use
The specific date of physical restraint use to each patient is documented.
Measured: 2010-2023
Reason for physical restraint use
The documented reason for applying physical restraints, as recorded in nursing and physician progress notes, is analyzed.
Measured: 2010-2023
Type of physical restraints used
The specific type of physical restraints used to patients during ICU stay is recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 2010-2023
Fluid balance data
Fluid balance data, including the administration of fluids such as blood products, crystalloids, and enteral/parenteral nutrition, are documented
Measured: 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.
Measured: 2010-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical RestraintsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raoul Sutter, Prof. Dr. med., Principal investigator, University Hospital Basel, Clinic for Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921070
- Sponsor's protocol ID
- 2024-00057; am23Sutter
- Status last verified
- Jun 2026
- First submitted
- 18 Mar 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usage and Adverse Events of Physical Restraints in an Intensive Care Unit - an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06921070
- Acronym / sponsor ID
- 2024-00057; am23Sutter
- Conditions
- Physical Restraints
- Keywords
- Intensive Care
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine the frequency with which physical restraints are used in a Swiss ICU
- Identify the type and frequency of adverse events associated with physical restraint use
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients younger than 18 years.
- Patients with documented refusal to use data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient demographics
Time frame: 2010-2023
Demographic information (e.g. age, sex) is collected to assess potential associations with physical restraint use.
Acute prehospital management data
Time frame: 2010-2023
Data from acute prehospital management, as documented in emergency medical services (EMS) treatment protocols, is collected
Duration of ICU stay
Time frame: 2010-2023
The length of ICU stay is recorded.
Duration of hospital stay
Time frame: 2010-2023
The length of the total hospital stay is recorded.
Discharge destination
Time frame: 2010-2023
The destination at discharge is recorded.
Date of physical restraint use
Time frame: 2010-2023
The specific date of physical restraint use to each patient is documented.
Reason for physical restraint use
Time frame: 2010-2023
The documented reason for applying physical restraints, as recorded in nursing and physician progress notes, is analyzed.
Type of physical restraints used
Time frame: 2010-2023
The specific type of physical restraints used to patients during ICU stay is recorded.
Restraint Duration
Time frame: 2010-2023
To characterize the restraint period, the duration of the physical restraint period is collected from the patient record in the hospital file.
Level of consciousness at onset of restraint
Time frame: 2010-2023
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.
Clinical neurologic monitoring score
Time frame: 2010-2023
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.
Critical illness severity score
Time frame: 2010-2023
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.
Charlson Comorbidity Index
Time frame: 2010-2023
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.
Laboratory parameters
Time frame: 2010-2023
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.
Complications associated with physical restraint use
Time frame: 2010-2023
The complication occurring during or after physical restraint use, including infections, shock, hemorrhage, ischemia, hypoxia, arrhythmia, cardiopulmonary arrest, and organ failure, is recorded.
Glasgow Outcome Score
Time frame: 2010-2023
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).
Therapeutic intervention
Time frame: 2010-2023
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.
Vital signs
Time frame: 2010-2023
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.
Fluid balance data
Time frame: 2010-2023
Fluid balance data, including the administration of fluids such as blood products, crystalloids, and enteral/parenteral nutrition, are documented
Diagnostic procedure
Time frame: 2010-2023
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raoul Sutter, Prof. Dr. med. principal investigator
University Hospital Basel, Clinic for Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Restraints, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient demographics (time frame: 2010-2023). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.