Physical Restraint of Critically Ill Patients

NCT04771793 | Completed

• 1 other identifier: 0420-20-MMC
• Study Type: observational
• Target: 992
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Prevalence of physical restraint in ICU patients

  To assess the prevalence of physical restraint in ICU patients (%), both with and without mechanical ventilation support

  1 year (January 2020 - December 2020.

Study Arms (2)

Group A- before implentation of physical restraint protocols

Behavioral: new physical restraint protocols

Group B- after implentation of physical restraint protocols

Behavioral: new physical restraint protocols

Interventions

new physical restraint protocols BEHAVIORAL

new physical restraint protocols

Group A- before implentation of physical restraint protocols; Group B- after implentation of physical restraint protocols

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients aged 18--99 admitted to the General Intensive Care Unit from January 2020 to December 2020.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir medical center Kfar Saba

Kfar Saba, Israel

Location

Related Publications (1)

• Cohen S, Meyer A, Ifrach N, Dichtwald S. Physical restraint and associated agitation. Nurs Crit Care. 2024 Sep;29(5):1132-1141. doi: 10.1111/nicc.13130. Epub 2024 Jul 14.

  PMID: 39004848 DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 25, 2021
• Study Start: September 1, 2021
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

IL (1)