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| Name | Class |
|---|---|
| Healthy Design, LLC | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel restraint | Device | Use of a novel arm restraint |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-Emergent Severe Adverse Events [Safety] | 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. | Through study day 2 |
| Number of Clinician or Patient Lacerations | 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. | Through study day 2 |
| Number of Pressure Ulcers From Device | 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) | Through study day 2 |
| Number of Self-removals of Novel Restraint | Self-removal of novel restraint | Through study day 2 |
| Number of Damaging Events to Hospital Bed Rendering it Non-functional | Any damage to hospital bed from restraint device rendering it non-functional | Through study day 2 |
| Number of Damaging Events to ICU Equipment | Any damage to ICU equipment (e.g. ventilator) rendering it non-functional |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Self-extubations | Will record instances where participants remove own endotracheal tube | Through study day 2 |
| Number of Movements of Upper Extremities | Actigraphy counts of upper extremities as measured by Philliips actigraph, a device that records individual movements |
| Measure | Description | Time Frame |
|---|---|---|
| Enrolling Adequate Numbers of Patients | Number of participants enrolled in the study | 6-day study period |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont College of Medicine | Burlington | Vermont | 05405 | United States |
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In two academic ICUs within the same medical center, non-comatose, mechanically ventilated adults >25 years old who required restraints and had an expected ICU stay of at least 2 days were evaluated for eligibility. The recruitment period was 10/2/2018 -- 4/8/2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Novel Restraint First, Then Traditional Restraint | Participants were 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 wore both kinds of restraints in the opposite order. Novel restraint: Use of a novel arm restraint |
| FG001 | Traditional Restraint First, Then Novel Restraint | Participants were 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 wore both kinds of restraints in the opposite order. Novel restraint: Use of a novel arm restraint |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Novel Restraint First, Then Traditional Restraint | Crossover design in which participants were 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 wore both kinds of restraints in the opposite order. Novel restraint: Use of a novel arm restraint |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Treatment-Emergent Severe Adverse Events [Safety] | 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. | Posted | Number | number of safety events | Through study day 2 |
|
Adverse event data were collected for up to 2 days while the participants were enrolled in the study and required physical restraint as determined by the clinical team.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Novel Restraint | Per intervention | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Renee Stapleton, MD, PhD | University of Vermont | (802) 656-7975 | renee.stapleton@med.uvm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2018 | Jan 25, 2023 | Prot_SAP_000.pdf |
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| Through study day 2 |
| Continuously through study day 2 |
| Richmond Agitation Sedation Score [RASS] | Agitation measured by the median of Richmond agitation sedation score [RASS] collected longitudinally every hour while wearing restraints. This score measures sedation and agitation from a scale of -5 (most sedated) to +4 (most agitated) | Median of multiple RASS scores collected over first 2 days of study period |
| Satisfaction With Novel Device as Assessed by the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST) Satisfaction Score | Satisfaction with the novel restraint device will be measured with the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) satisfaction tool. This 12-item questionnaire is scored from 1 (lowest satisfaction) to 5 (highest satisfaction). | Study day 2 |
| Delerium Score | We intended to measure delirium score as accessed by the CAM-ICU. However, during the study we were unable to measure it because it was too often incorrectly charted by nursing. We therefore have nothing to report for this planned outcome. | 6-day study period |
| BG001 | Traditional Restraint First, Then Novel Restraint | Crossover design in which participants were randomized to wear the traditional arm restraint bilaterally for 4 hours on study day #1, followed by novel soft bilateral wrist restraints for 4 hours. Then, on study day #2, they wore both kinds of restraints in the opposite order. Novel restraint: Use of a novel arm restraint |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Primary | Number of Clinician or Patient Lacerations | 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. | Posted | Number | number of clinician/patient lacerations | Through study day 2 |
|
|
|
| Primary | Number of Pressure Ulcers From Device | 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) | Posted | Number | number of pressure ulcers | Through study day 2 |
|
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| Primary | Number of Self-removals of Novel Restraint | Self-removal of novel restraint | Posted | Number | number of restraint removals | Through study day 2 |
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| Primary | Number of Damaging Events to Hospital Bed Rendering it Non-functional | Any damage to hospital bed from restraint device rendering it non-functional | Posted | Number | number of damage events to bed incidents | Through study day 2 |
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| Primary | Number of Damaging Events to ICU Equipment | Any damage to ICU equipment (e.g. ventilator) rendering it non-functional | Posted | Number | number of damage events to ICU equipment | Through study day 2 |
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| Secondary | Number of Self-extubations | Will record instances where participants remove own endotracheal tube | Posted | Number | number of self-extubations | Through study day 2 |
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| Secondary | Number of Movements of Upper Extremities | Actigraphy counts of upper extremities as measured by Philliips actigraph, a device that records individual movements | Enrolled subjects who wore the restraint/restraint alternative devices | Posted | Number | number of movement events | Continuously through study day 2 |
|
|
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| Secondary | Richmond Agitation Sedation Score [RASS] | Agitation measured by the median of Richmond agitation sedation score [RASS] collected longitudinally every hour while wearing restraints. This score measures sedation and agitation from a scale of -5 (most sedated) to +4 (most agitated) | Posted | Median | Inter-Quartile Range | score on a scale | Median of multiple RASS scores collected over first 2 days of study period |
|
|
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| Secondary | Satisfaction With Novel Device as Assessed by the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST) Satisfaction Score | Satisfaction with the novel restraint device will be measured with the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) satisfaction tool. This 12-item questionnaire is scored from 1 (lowest satisfaction) to 5 (highest satisfaction). | Posted | Median | Inter-Quartile Range | score on a scale | Study day 2 |
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| Secondary | Delerium Score | We intended to measure delirium score as accessed by the CAM-ICU. However, during the study we were unable to measure it because it was too often incorrectly charted by nursing. We therefore have nothing to report for this planned outcome. | We intended to measure delirium score as accessed by the CAM-ICU. However, during the study we were unable to measure it because it was too often incorrectly charted by nursing. We therefore have nothing to report for this planned outcome. | Posted | No | 6-day study period |
|
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| Other Pre-specified | Enrolling Adequate Numbers of Patients | Number of participants enrolled in the study | participants enrolled in the study | Posted | Count of Participants | Participants | 6-day study period |
|
|
|
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Traditional Restraint | Per intervention | 0 | 7 | 0 | 7 | 0 | 7 |
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