Clinical trial NCT04067622: Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment
Official title: Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Encephalopathy
ARDS
Sepsis
Critical Illness
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: University of California, San Diego
name: Healthy Design, LLC
First posted: 2019-08-26
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within-patient, randomized crossover design.
Primary purpose: TREATMENT

Brief summary: This study evaluates a novel arm restraint compared with traditional soft wrist restraints in older critically ill patients. The primary outcome is upper extremity mobility measured by actigraphy, and secondary outcomes include sedation, agitation, satisfaction, and acceptability.

Detailed description: The goal of this Fast-Track STTR project is to optimize and test a novel arm restraint in older critically ill patients that increases mobility; reduces agitation, use of sedative medications, and delirium; and exhibits high satisfaction and acceptability among hospital staff, family members, and patients. Older critically ill patients are often immobilized with wrist restraints to prevent self-removal of tubes and lines and are sedated to reduce agitation caused by their restraints and endotracheal (breathing) tube. This sedation and immobility lead to complications, including delirium and muscle weakness, that are independently associated with long term cognitive impairment, reduced physical functioning, and mortality. Specifically, the incidence and duration of delirium in the ICU are strongly and independently associated with long-term cognitive impairment that is similar to Alzheimer's Disease and Related Dementias.

Healthy Design is developing the novel ExersidesTM restraint that allows arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines. Because it permits mobility, ExersidesTM may reduce agitation and the need for sedatives. In preliminary pilot testing, ExersidesTM has demonstrated very encouraging results. The objectives of this STTR Fast-Track project are to optimize ExersidesTM and evaluate it in a randomized controlled trial (RCT) in older critically ill patients at high risk for delirium and associated long-term cognitive impairment. The multidisciplinary investigator team has expertise in critical care, extensive experience in conducting ICU RCTs, and a history of successful collaboration.

Phase I of the STTR, during which the novel restraint device was modified based on feedback from healthy volunteers and a single-center prospective pilot study was performed in 8 older patients with acute respiratory failure, has already been completed. The Phase I pilot study has demonstrated that 1) the revised ExersidesTM prototype is safe and 2) the RCT proposed in Phase II is feasible.

Therefore, Phase II of the STTR will now occur. In Phase II, a multi-site within-patient crossover RCT in older critically ill patients requiring restraint will be conducted to test the following outcomes in ExersidesTM versus traditional wrist restraint: 1) Mobility assessed by actigraphy (primary outcome); 2) Agitation, delirium, and medication use (secondary outcomes); and 3) Satisfaction with and acceptability/perceptions of the device (secondary outcomes). Successful completion of this project will result in an ExersidesTM restraint that is ready for final optimization in preparation for commercialization, and is suitable for larger clinical studies to demonstrate effectiveness reducing long-term cognitive impairment in older ICU patients.

Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* Requiring ICU care
* Requiring wrist or mitt restraints and has active physician order
* Expected ICU stay ≥2 days after enrollment
* Responsive to verbal stimulus

Exclusion Criteria:

* Bilateral upper extremity impairments (e.g. arm injuries) or problems (e.g. severe skin breakdown) that prevent use of novel restraint device. Normal use of one arm (e.g. unilateral upper extremity amputation) is acceptable.
* Very limited mobility of bilateral upper extremities prior to admission (e.g. bilateral frozen shoulders). Normal use of one arm is acceptable.
* Pre-existing severe neuromuscular condition inhibiting or axacerbating upper extremity movement (e.g. Guillain-Barre, severe tremor, myoclonus)
* Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)
* Pre-existing severe cognitive impairment or language barrier prohibiting outcome assessment
* Expected death or withdrawal of life-sustaining treatments within 6 days from enrollment
* Incarcerated
* Pregnant
* Attending physician declines patient enrollment
* LAR unavailable to consent (and patient is unable to consent)
* Patient or LAR decline consent

Primary outcomes:
measure: Mobility assessed by actigraphy
timeFrame: Up to 6 days
Secondary outcomes:
measure: Sedation/Agitation
timeFrame: Baseline, every 60 minutes on study days 1-2, every 4 hours on study days 3-6
measure: Delirium
timeFrame: Baseline, every 4 hours days 1-2, twice daily days 3-6
measure: Average cumulative dose of sedative medications
timeFrame: Up to 6 days
measure: Average cumulative dose of analgesic medications
timeFrame: Up to 6 days
measure: Average cumulative dose of antipsychotic medications
timeFrame: Up to 6 days
Other outcomes:
measure: Satisfaction with novel restraint (nurses, family, physicians, and patients when able)
timeFrame: Up to 6 days
measure: Acceptability of novel restraint (nurses, family, physicians, and patients when able)
timeFrame: Up to 6 days
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Renee Stapleton, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Dale Needham, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: