Phase 1
Completed N=8
Novel Arm Restraint in the Intensive Care Unit
Source: ClinicalTrials.gov NCT03621475 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Number of Treatment-Emergent Severe Adverse Events [Safety] — 0; 0 number of safety events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment-Emergent Severe Adverse Events [Safety] |
0; 0 | — |
| PRIMARY Number of Clinician or Patient Lacerations |
0; 0 | — |
| PRIMARY Number of Pressure Ulcers From Device |
0; 0 | — |
| PRIMARY Number of Self-removals of Novel Restraint |
0; 0 | — |
| PRIMARY Number of Damaging Events to Hospital Bed Rendering it Non-functional |
0; 0 | — |
| PRIMARY Number of Damaging Events to ICU Equipment |
0; 0 | — |
| SECONDARY Number of Self-extubations |
0; 0 | — |
| SECONDARY Number of Movements of Upper Extremities |
27,509; 24,686 | — |
| SECONDARY Richmond Agitation Sedation Score [RASS] |
-1.5; -1 | — |
| SECONDARY Satisfaction With Novel Device as Assessed by the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST) Satisfaction Score |
3.5 | — |
| SECONDARY Delerium Score |
— | — |
Eligibility Criteria
Inclusion Criteria
- >65 years old
- Physician order for use of bilateral wrist restraints
- Requiring mechanical ventilation with actual or expected total duration of >48 hours
- Expected ICU stay >3 days after enrollment (to permit adequate exposure to proposed intervention)
- Not deeply sedated (Richmond Agitation Sedation Scale [RASS] score > -2)
Exclusion Criteria
- Upper extremity impairments that prevent use of novel restraint device (e.g. amputation, arm injury)
- Limited mobility of either upper extremity prior to admission (e.g. frozen shoulder, severe arthritis)
- Pre-existing primary systemic neuromuscular disease (e.g. Guillain-Barre)
- 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
- Severe skin breakdown on either upper extremity
Data sourced from ClinicalTrials.gov (NCT03621475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.