Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03621475 | Novel Arm Restraint in the Intensive Care Unit | PHASE1 | COMPLETED | 8 | — | — | Oct 1, 2018 | Apr 15, 2019 | May 29, 2025 | 1 | United States |
Safety will be measured by the number (i.e. \< 1 in 5 participants had a treatment emergent safety event per their on study time) across all of the following measures listed below. Incidence does not have to be per person-year; in this case it is incidence of safety adverse event during the study period.
Grade 2b or higher skin laceration (per Skin Tear Audit Research \[STAR\] Skin Tear Classification System) in patient or clinician from any sharp edges of device. The STAR grading system ranges from grade 1a at best to 3 at worst. Each laceration is given an individual score based on appearance.
Development of pressure ulcer from device of Stage 3 or greater per 2016 National Pressure Ulcer Advisory Panel Pressure Injury Stages. This staging system provides an individual score to each pressure ulcer based on appearance from stage 1 (best) to stage 4 (worst)
Self-removal of novel restraint
Any damage to hospital bed from restraint device rendering it non-functional
Any damage to ICU equipment (e.g. ventilator) rendering it non-functional
| Arm | Type | Description |
|---|---|---|
| Novel restraint first, then traditional restraint | EXPERIMENTAL | Participants will be randomized to wear the novel arm restraint bilaterally for 4 hours on study day #1, followed by traditional soft bilateral wrist restraints for 4 hours. Then, on study day #2, they will wear both kinds of restraints in the opposite order. |
| Traditional restraint first, then novel restraint | EXPERIMENTAL | Participants will be randomized to wear traditional soft bilateral wrist restraints for 4 hours on study day #1, followed by the novel arm restraint bilaterally for 4 hours. Then, on study day #2, they will wear both kinds of restraints in the opposite order. |
| Name | Type | Description |
|---|---|---|
| Novel restraint | DEVICE | Use of a novel arm restraint |
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...