Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04771793 |
| Other study ID # |
0420-20-MMC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
March 14, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
Meir Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background: Physical restraint of patients in the intensive care unit (ICU) is a common
practice, with estimated prevalence of 50% of all ICU patients, with and without invasive
ventilation support(1). The prevalence of physical restraint varies between ICU's according
to patient population (surgical, cardiac, trauma, burns and general intensive care patients).
In mechanically ventilated patients, the physical restriction (tying the patient) is carried
out frequently in addition to pharmacological treatment with analgesic and sedative
medications, in order to prevent falling, self-inflicted injury or accidental removal of
essential medical devices (tracheobronchial tubes, central venous infusions, drains, etc.) by
the patient. In non-ventilated patients, physical restraint is often carried out in patients
with delirium or cognitive decline, in addition to pharmacological anti -delirium therapy
(1).
However, physical restraint has many drawbacks, including injuries to the skin and the soft
tissues, blood vessels, peripheral nerves, muscle and skeleton (2). In addition, physical
restraint may exacerbate symptoms of restlessness and delirium and even increase the risk of
developing post-traumatic stress disorder in these patients (3,4).
Despite the high prevalence of physical restraint of ICU patients, with its disadvantages and
advantages, currently there are no consensual criteria for physical restraint and the
decision when and how long to use it is at the discretion of the attending physician. It is
important to note that in recent years there has been a tendency to reduce the amount of
sedation that mechanically ventilated patients are given, which may lead to an increase in
the incidence of physical restraint of patients who are fully or partially conscious (5).
Description:
Background: Physical restraint of patients in the intensive care unit (ICU) is a common
practice, with estimated prevalence of 50% of all ICU patients, with and without invasive
ventilation support(1). The prevalence of physical restraint varies between ICU's according
to patient population (surgical, cardiac, trauma, burns and general intensive care patients).
In mechanically ventilated patients, the physical restriction (tying the patient) is carried
out frequently in addition to pharmacological treatment with analgesic and sedative
medications, in order to prevent falling, self-inflicted injury or accidental removal of
essential medical devices (tracheobronchial tubes, central venous infusions, drains, etc.) by
the patient. In non-ventilated patients, physical restraint is often carried out in patients
with delirium or cognitive decline, in addition to pharmacological anti -delirium therapy
(1).
However, physical restraint has many drawbacks, including injuries to the skin and the soft
tissues, blood vessels, peripheral nerves, muscle and skeleton (2). In addition, physical
restraint may exacerbate symptoms of restlessness and delirium and even increase the risk of
developing post-traumatic stress disorder in these patients (3,4).
Despite the high prevalence of physical restraint of ICU patients, with its disadvantages and
advantages, currently there are no consensual criteria for physical restraint and the
decision when and how long to use it is at the discretion of the attending physician. It is
important to note that in recent years there has been a tendency to reduce the amount of
sedation that mechanically ventilated patients are given, which may lead to an increase in
the incidence of physical restraint of patients who are fully or partially conscious (5).
Objectives: In the first stage of our planned study (in this study) - we would like to assess
the prevalence of physical restraint in ICU patients, both with and without mechanical
ventilation support, their clinical characteristics and the rate of delirium among them. In
the second stage of the study (in a future study) - we plan to install specific protocols for
physical restraint, aiming to decrease the rate of physical restraint of patients in our ICU.
The data obtained from the first phase of the study can help us characterize the patients who
require physical restraint in the ICU, which from we will attempt to generate protocols that
will help us reduce the prevalence of physical restraint in the unit. For example, if the
group of patients who required physical restraint tended to experience delirium more often,
as measured by the RASS score, we could formulate a special protocol for the treatment of
delirium in these patients, which might reduce the need for physical restraint in some cases.
We can address factors that may alter the incidence of delirium, such as emphasizing the
importance of renewing as soon as possible all regular patients' pharmacological therapy with
antipsychotic drugs, if any, or to soon start treatment to prevent withdrawal syndrome (in
case of chronic ethanol abuse, or regular benzodiazepine treatment. Alternative measures can
also be used to decrease delirium prevalence, such as presence of the patient's family
member, music, television, maintaining the patient's room dark at night hours, etc.), as well
as other measures. The characterization of those patients is essential for the formulation of
such treatment protocols.
Methods and materials:
Study type: Retrospective study based on data collection. Data will be extracted from the
hospital computerized systems. The study will include all our ICU admitted patients from
1.1.2020 to 31.12.2020. About 1000 patients total.
Inclusion criteria: All patients aged 18--99 admitted to the General Intensive Care Unit from
January 2020 to the end of December 2020.
Data collection: Retrospective observational data collection from hospital records and
computerized systems (Chameleon system and iMDsoft software).
Collected data: Age, gender, hospital and ICU admission times, ventilation days, 28-day
mortality, past medical history including chronic medication therapy, APACHE-2 score,
admission lactate level, need for pressor or inotropic support, need for dialysis, need for
tracheostomy, type of ICU admission (Infectious, trauma etc.), delirium score measured by the
RASS score, need for physical restraint, duration of physical restraint, prevalence of self
extubation, prevalence of self-inflicted injuries including falls and inadvertent retrieval
of tubes or other medical devices.
Study group size: 1000 patients. Statistical analysis: All demographic and intra-patient
parameters will be statistically examined by a qualified statistician depending on the type
of data. The current study group will be the control group (before intervention), and the
second group will be the treatment group (after intervention, i.e. after creating and
installing new physical restraint protocols in the ICU) .We will use the Chi square test to
analyze the discrete data and the Mann-Whitney test to analyze the continuous data.
