Acute Respiratory Failure
Conditions
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.
Interventions
DEVICENovel restraint
Use of a novel arm restraint
Sponsors
Healthy Design, LLC
University of Vermont
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Damaging Events to ICU Equipment | Through study day 2 | Any damage to ICU equipment (e.g. ventilator) rendering it non-functional |
| Number of Treatment-Emergent Severe Adverse Events [Safety] | Through study day 2 | 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. |
| Number of Clinician or Patient Lacerations | Through study day 2 | 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. |
| Number of Pressure Ulcers From Device | Through study day 2 | 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) |
| Number of Self-removals of Novel Restraint | Through study day 2 | Self-removal of novel restraint |
| Number of Damaging Events to Hospital Bed Rendering it Non-functional | Through study day 2 | Any damage to hospital bed from restraint device rendering it non-functional |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Self-extubations | Through study day 2 | Will record instances where participants remove own endotracheal tube |
| Number of Movements of Upper Extremities | Continuously through study day 2 | Actigraphy counts of upper extremities as measured by Philliips actigraph, a device that records individual movements |
| Richmond Agitation Sedation Score [RASS] | Median of multiple RASS scores collected over first 2 days of study period | 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) |
| Satisfaction With Novel Device as Assessed by the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST) Satisfaction Score | Study day 2 | 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). |
| Delerium Score | 6-day study period | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Enrolling Adequate Numbers of Patients | 6-day study period | Number of participants enrolled in the study |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| 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 | 3 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No longer required restraints at initiation | 0 | 1 |
Baseline characteristics
| Characteristic | Novel Restraint First, Then Traditional Restraint | Total | Traditional Restraint First, Then Novel Restraint |
|---|---|---|---|
| Age, Customized | 65.5 years | 65 years | 64 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 7 Participants | 3 Participants |
| Region of Enrollment United States | 4 participants | 7 participants | 3 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
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.
Time frame: Through study day 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Novel Restraint | Number of Clinician or Patient Lacerations | 0 number of clinician/patient lacerations |
| Traditional Restraint | Number of Clinician or Patient Lacerations | 0 number of clinician/patient lacerations |
Primary
Number of Damaging Events to Hospital Bed Rendering it Non-functional
Any damage to hospital bed from restraint device rendering it non-functional
Time frame: Through study day 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Novel Restraint | Number of Damaging Events to Hospital Bed Rendering it Non-functional | 0 number of damage events to bed incidents |
| Traditional Restraint | Number of Damaging Events to Hospital Bed Rendering it Non-functional | 0 number of damage events to bed incidents |
Primary
Number of Damaging Events to ICU Equipment
Any damage to ICU equipment (e.g. ventilator) rendering it non-functional
Time frame: Through study day 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Novel Restraint | Number of Damaging Events to ICU Equipment | 0 number of damage events to ICU equipment |
| Traditional Restraint | Number of Damaging Events to ICU Equipment | 0 number of damage events to ICU equipment |
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)
Time frame: Through study day 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Novel Restraint | Number of Pressure Ulcers From Device | 0 number of pressure ulcers |
| Traditional Restraint | Number of Pressure Ulcers From Device | 0 number of pressure ulcers |
Primary
Number of Self-removals of Novel Restraint
Self-removal of novel restraint
Time frame: Through study day 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Novel Restraint | Number of Self-removals of Novel Restraint | 0 number of restraint removals |
| Traditional Restraint | Number of Self-removals of Novel Restraint | 0 number of restraint removals |
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.
Time frame: Through study day 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Novel Restraint | Number of Treatment-Emergent Severe Adverse Events [Safety] | 0 number of safety events |
| Traditional Restraint | Number of Treatment-Emergent Severe Adverse Events [Safety] | 0 number of safety events |
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.
Time frame: 6-day study period
Population: 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.
Secondary
Number of Movements of Upper Extremities
Actigraphy counts of upper extremities as measured by Philliips actigraph, a device that records individual movements
Time frame: Continuously through study day 2
Population: Enrolled subjects who wore the restraint/restraint alternative devices
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Novel Restraint | Number of Movements of Upper Extremities | 27,509 number of movement events |
| Traditional Restraint | Number of Movements of Upper Extremities | 24,686 number of movement events |
Secondary
Number of Self-extubations
Will record instances where participants remove own endotracheal tube
Time frame: Through study day 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Novel Restraint | Number of Self-extubations | 0 number of self-extubations |
| Traditional Restraint | Number of Self-extubations | 0 number of self-extubations |
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)
Time frame: Median of multiple RASS scores collected over first 2 days of study period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Novel Restraint | Richmond Agitation Sedation Score [RASS] | -1.5 score on a scale |
| Traditional Restraint | Richmond Agitation Sedation Score [RASS] | -1 score on a scale |
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).
Time frame: Study day 2
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Novel Restraint | Satisfaction With Novel Device as Assessed by the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST) Satisfaction Score | 3.5 score on a scale |
Other Pre-specified
Enrolling Adequate Numbers of Patients
Number of participants enrolled in the study
Time frame: 6-day study period
Population: participants enrolled in the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Novel Restraint | Enrolling Adequate Numbers of Patients | 4 Participants |
| Traditional Restraint | Enrolling Adequate Numbers of Patients | 4 Participants |