Clinical trial NCT03621475: Novel Arm Restraint in the Intensive Care Unit
Official title: Pilot Study of a Novel Arm Restraint For Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Respiratory Failure
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Healthy Design, LLC
First posted: 2018-08-08
Enrollment: 8
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The goal of this pilot is to evaluate a novel restraint device in 8 older mechanically ventilated patients to demonstrate that 1) the revised novel restraint prototype is safe and 2) a future randomized controlled trial (RCT) is feasible.

Detailed description: The goal of this Fast-Track Small Business Technology Transfer (STTR) project is to optimize and test a novel arm restraint in older critically ill mechanically ventilated patients that may increase mobility; reduce agitation, use of sedative medications, and delirium; and exhibit high satisfaction and acceptability among hospital staff, family members, and patients. Older mechanically ventilated patients are often immobilized with wrist restraints to prevent self-extubation 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 has developed a novel restraint device that allows arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines. Because it permits mobility, the novel restraint may reduce agitation and the need for sedatives. The objectives of this pilot study are to evaluate the novel restraint in 8 older mechanically ventilated patients to demonstrate that 1) the revised novel restraint prototype is safe and 2) a future RCT is feasible.

Eligibility criteria: Inclusion Criteria:

1. \>65 years old
2. Physician order for use of bilateral wrist restraints
3. Requiring mechanical ventilation with actual or expected total duration of \>48 hours
4. Expected ICU stay \>3 days after enrollment (to permit adequate exposure to proposed intervention)
5. Not deeply sedated (Richmond Agitation Sedation Scale \[RASS\] score \> -2)

Exclusion Criteria:

1. Upper extremity impairments that prevent use of novel restraint device (e.g. amputation, arm injury)
2. Limited mobility of either upper extremity prior to admission (e.g. frozen shoulder, severe arthritis)
3. Pre-existing primary systemic neuromuscular disease (e.g. Guillain-Barre)
4. Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)
5. Pre-existing severe cognitive impairment or language barrier prohibiting outcome assessment
6. Expected death or withdrawal of life-sustaining treatments within 6 days from enrollment
7. Incarcerated
8. Severe skin breakdown on either upper extremity

Primary outcomes:
measure: Number of Treatment-Emergent Severe Adverse Events [Safety]
timeFrame: Through study day 2
measure: Number of Clinician or Patient Lacerations
timeFrame: Through study day 2
measure: Number of Pressure Ulcers From Device
timeFrame: Through study day 2
measure: Number of Self-removals of Novel Restraint
timeFrame: Through study day 2
measure: Number of Damaging Events to Hospital Bed Rendering it Non-functional
timeFrame: Through study day 2
measure: Number of Damaging Events to ICU Equipment
timeFrame: Through study day 2
Secondary outcomes:
measure: Number of Self-extubations
timeFrame: Through study day 2
measure: Number of Movements of Upper Extremities
timeFrame: Continuously through study day 2
measure: Richmond Agitation Sedation Score [RASS]
timeFrame: Median of multiple RASS scores collected over first 2 days of study period
measure: Satisfaction With Novel Device as Assessed by the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST) Satisfaction Score
timeFrame: Study day 2
measure: Delerium Score
timeFrame: 6-day study period
Other outcomes:
measure: Enrolling Adequate Numbers of Patients
timeFrame: 6-day study period
Locations:
city: Burlington
country: United States
facility: University of Vermont College of Medicine
state: Vermont
Study officials:
References: