NCT03621475

Novel Arm Restraint in the Intensive Care Unit

Pilot Study of a Novel Arm Restraint For Critically Ill Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Failure

Interventions

Type	Name	Description
DEVICE	Novel restraint	Use of a novel arm restraint

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-04-11
• Completion: 2019-04-15
• First posted: 2018-08-08
• Last updated: 2025-05-29
• Results posted: 2025-05-29

Locations

1 site across 1 country: United States