Usage and Adverse Events of Physical Restraints in an Intensive Care Unit - an Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Patient demographics
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients younger than 18 years.
- •Patients with documented refusal to use data.
结局指标
主要结局
Patient demographics
时间窗: 2010-2023
Demographic information (e.g. age, sex) is collected to assess potential associations with physical restraint use.
Acute prehospital management data
时间窗: 2010-2023
Data from acute prehospital management, as documented in emergency medical services (EMS) treatment protocols, is collected
Duration of ICU stay
时间窗: 2010-2023
The length of ICU stay is recorded.
Duration of hospital stay
时间窗: 2010-2023
The length of the total hospital stay is recorded.
Discharge destination
时间窗: 2010-2023
The destination at discharge is recorded.
Date of physical restraint use
时间窗: 2010-2023
The specific date of physical restraint use to each patient is documented.
Reason for physical restraint use
时间窗: 2010-2023
The documented reason for applying physical restraints, as recorded in nursing and physician progress notes, is analyzed.
Type of physical restraints used
时间窗: 2010-2023
The specific type of physical restraints used to patients during ICU stay is recorded.
Restraint Duration
时间窗: 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
时间窗: 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.
Complications associated with physical restraint use
时间窗: 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.
Diagnostic procedure
时间窗: 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.
Laboratory parameters
时间窗: 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.
Clinical neurologic monitoring score
时间窗: 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
时间窗: 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
时间窗: 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.
Glasgow Outcome Score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 2010-2023
Fluid balance data, including the administration of fluids such as blood products, crystalloids, and enteral/parenteral nutrition, are documented
次要结局
未报告次要终点